Báez-Suárez et al.

Trials (2018) 19:652

https://doi.org/10.1186/s13063-018-3036-2

RESEARCH Open Access

Evaluation of different doses of

transcutaneous nerve stimulation for pain
relief during labour: a randomized
controlled trial
Aníbal Báez-Suárez* , Estela Martín-Castillo, Josué García-Andújar, José Ángel García-Hernández,
María P. Quintana-Montesdeoca and Juan Francisco Loro-Ferrer

Abstract
Background: Pain during labour is one of the most intense pain that women may experience in their lifetime.
There are several non-pharmacological analgesic methods to relieve pain during labour, among them
transcutaneous electrical nerve stimulation (TENS). TENS is a low-frequency electrotherapy technique, analgesic
type, generally used in musculoskeletal pathology, but it has also come to be used as an alternative treatment
during labour. The purpose of this study is to investigate the pain-relieving effect of a TENS application during
labour and to find out the most effective dose.
Methods: This study is a randomized, double-blind, placebo-controlled trial. TENS therapy was initiated at the
beginning of the active phase of labour. Participants were randomly assigned to three groups (21 per group: two
active TENS and one placebo). Active TENS 1 intervention consisted in a constant frequency of 100-Hz, 100-μs,
active TENS 2 intervention consisted in a varying high-frequency (80–100 Hz), 350 μs, and in a placebo group,
participants were connected to the TENS unit without electrical stimulation. TENS was applied with two self-
adhesive electrodes placed parallel to the spinal cord (T10–L1 and S2–S4 levels). The primary outcome was pain
intensity (0–10 cm) measured on a visual analogue scale (VAS) at several stages (at baseline and at 10 and 30 min
later). Secondary outcomes included women’s satisfaction (via the Care in Obstetrics: Measure for Testing
Satisfaction scale).
Results: Sixty-three women participated. Regarding baseline characteristics, no differences were found among the
three groups. The active TENS 2 group obtained an improvement with clinically significant VAS results (− 2.9, 95%
confidence interval – 4.1 to − 1.6, p < 0.001). Regarding satisfaction, the results also revealed better results in the
active TENS than in the placebo group.
Conclusions: TENS with high frequencies modified in time as well as high pulse width are effective for relieving
labour pain, and they are well considered by pregnant participants.
Trial registration: ClinicalTrials.gov, NCT03137251. Registered on 2 May 2017.
Keywords: Transcutaneous electrical nerve stimulation, Pain relief, Randomized controlled trial, Obstetric labour,
Physical therapy modality

* Correspondence: [email protected]
Department of Medical and Surgical Sciences, University of Las Palmas de
Gran Canaria, Paseo Blas Cabrera Felipe, s/n, 35016 Las Palmas de Gran
Canaria, Las Palmas, Spain

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Báez-Suárez et al. Trials (2018) 19:652 Page 2 of 10

Background Ethics Committee (ID CEIm-CHUIMI-2016/875), and it

Pain during labour is one of the most intense types of followed the ethical guidelines set out in the Declaration
pain that a woman may experience in her lifetime, and it of Helsinki. It was also conducted in accordance with the
can be influenced by anatomical and physiological fac- Good Clinical Practice (GCP) guidelines. All patients
tors and by women’s own experiences, as well as by cul- signed an informed consent statement before starting the
tural, social, and environmental factors [1]. Moreover, study.
mothers who experience high levels of pain during preg- When the Hospital’s Human Ethics Committee ap-
nancy have an increased risk of complications during proved the trial in December 2016, we undertook a pilot
labour, like foetal tachycardia, vaginal tears, or alteration study with 20 patients. They did not take part in the
in foetal blood samples [2]. final trial and they were excluded for the current ana-
Neuraxial analgesia during labour is the most effective lysis. We just wanted to detect possible difficulties in the
method for pain relief, but it appears to be associated with process; for this reason, these patients were not regis-
certain side effects, such as maternal hypotension, de- tered under NCT03137251. Subsequently, 63 partici-
creased uteroplacental perfusion, foetal bradycardia, mater- pants were enrolled at the Complejo Hospitalario
nal fever and pruritus, an increased oxytocin requirement, Universitario Insular-Materno Infantil (Spain) between
a prolonged second stage of labour, a higher rate of caesar- May 2, 2017 and August 30, 2017. The inclusion criteria
ean deliveries, and especially, higher costs [3]. were as follows: aged above 18, women with a low-risk
Non-pharmacological methods for pain relief include a pregnancy, a gestational age between 37 and 42 weeks, a
wide variety of techniques aimed at improving physical single foetus, and cervical dilatation of at least 4 cm. Ex-
sensations and preventing the psychoemotional percep- clusion criteria included the following: aged below 18, a
tion of pain. Among the main non-pharmacological planned caesarean, a high-risk pregnancy, cutaneous
methods of pain relief for childbirth is the application of damage at the TENS application sites, women wearing a
transcutaneous electrical nerve stimulation (TENS). Its pacemaker or automatic implanted cardiac defibrillator,
application during childbirth is based on the gait control inability to understand or refusal to sign the informed
theory of pain of Melzack and Wall [4]. Furthermore, consent form, and previous experience with TENS.
many non-pharmacological methods of managing pain The sample size and power calculations were performed
increase the satisfaction of women with regard to their using the software GRANMO 7.11. Calculations were
labour experience [5, 6]. based on detecting differences of 1.3 units on a 10 numer-
TENS has been used for labour analgesia, and there are ical pain rate scale at post-data, an alpha level of 0.05, and
several studies which show its effectiveness and safety [7– a desired power of 80%. These assumptions generated a
10]. The effectiveness of TENS depends on the duration, sample size of 63 subjects, 21 per group. Participants in
frequency, and amplitude of the stimulating current and both groups received all other routine obstetric care. The
the location of the electrodes’ application [11]. Despite the participants were also instructed to choose the most com-
widespread use of TENS and its potential advantages for fortable position. The presence of an accompanying per-
the relief of labour pain, evidence from systematic reviews son was permitted during labour and delivery.
has been inconsistent in demonstrating clear benefits of Pregnant women who went to childbirth preparation
this method, and overall effect for pain relief using TENS courses were informed about the possibility of using
in labour was weak [12]. Most of the studies were small or TENS during labour. In this way, most participants had
non-randomized trials [13–15]. Furthermore, there is no been informed that a clinical trial was being conducted,
consensus in the current literature about the exact param- while the rest of the participants were informed once
eters that allow effective pain relief, and currently there is they were admitted.
no common protocol that provides us with an effective Participants were notified about alternative treatments,
clinical practice guide that allows us to be efficient in our responsibilities during the study, and the potential ad-
intervention. vantages and risks associated with this research. Possible
The aim of this double-blind, randomized, placebo- side effects caused by this intervention include redness
controlled trial was to investigate the pain-relieving effect at the electrode sites. However, these symptoms mostly
of a TENS application during labour and to find out the disappear spontaneously within a few days. The people
most effective dose. who attended the delivery of the study participants had a
minimum of 15 years of experience in the midwifery ob-
Materials and methods stetrics service.
Study design
We conducted a randomized, double-blind, placebo- Randomization and double blinding
controlled trial. This study (ClinicalTrials.gov ID Before starting the trial, investigator 1, who was not in-
NCT03137251) was approved by the Hospital’s Human volved in the selection and inclusion process, assigned a
Báez-Suárez et al. Trials (2018) 19:652 Page 3 of 10

number to each of the three devices designed using dif- waveform at a mixed stimulating frequency that randomly
ferent doses (one of them was a placebo). Investigator 2 varied between 80 and 100 Hz, and it had a pulse duration
generated the random sequence (based on simple of 350 μs. The device intensity (amplitude) was individu-
randomization) by using a computerized random num- ally titrated according to the sensitivity of each parturient.
ber generator [16]; these processes were concealed from Although this method of determining the level of intensity
the rest of the staff of the study. At the time of enrol- will result in a variation in delivered amplitude between
ment in the study, each of the 63 participants was ran- participants, it is consistent with the techniques of previ-
domly assigned to one of three groups, active TENS 1 ous literature and clinical practice [17–19]. All groups re-
(n = 21), active TENS 2 (n = 21), or TENS placebo (n = 21). ceived TENS constantly over 30 min starting at the
The participants and nurses who evaluated the results were beginning of the active phase of labour (4 cm of cervical
blinded to the group assignments. dilatation). Those women who were comfortable with the
To achieve and ensure blinding in the placebo group, TENS were allowed to use it for longer, although the pain
participants were connected to the TENS unit in exactly relief was only recorded during the first 30 min.
the same way as participants of the active TENS groups.
The active indicator of the unit emitted light and sound, Primary outcome
but it did not deliver electrical stimulation. In addition The primary outcome was the change in pain severity at
to this, the investigator who applied the device did not the end of the intervention period. The level of pain during
know if it was the active one or placebo. labour was measured on a 10-cm-long horizontal linear
visual analogical scale (VAS). Baseline VAS evaluations
Intervention were performed to assess the severity of pain on an inter-
TENS therapy was initiated at the beginning of the ac- mittent scale from 0 (‘no pain’) to 10 (‘worst pain imagin-
tive phase of labour. Investigator 1 programmed the able’). Evaluations were completed at three distinct stages
TENS unit and was the only researcher who knew if during the procedure: (1) at the beginning of the active
TENS was active or in placebo mode. The nurses who phase of labour, (2) after 10 min, and (3) after 30 min. We
attended the participants were trained by investigator 1 considered 1.3 cm the minimal clinically important differ-
as study personnel to operate the TENS on the assigned ence in pain relief [20–23].
points. However, an external nurse to the obstetrics ser- None of the participants used analgesic medication dur-
vice entered the data and checked the devices to ensure ing the time from admission to hospital until the end of the
that the dose administered was always the one pro- revaluation of the pain-related outcomes after the interven-
grammed in each device. Two pairs of electrodes meas- tion period. This allowed the data from all participants to
uring 5 × 9 cm were fixed on the paravertebral regions of be included in the analysis of pain outcomes without any
the participants at the T10–L1 and S2–S4 levels (Fig. 1). possible misleading effects of analgesic medication use.
The TENS device used in this study was a Cefar Rehab
2pro®. In the active TENS 1, it produced a modified bi- Secondary outcomes
phasic asymmetric pulse, and it was set to a pulse width The secondary outcome indicators included satisfaction
of 100 μs and a frequency of 100 Hz. In the active TENS levels and obstetric and neonatal outcomes.
2, it emitted an asymmetric, balanced, biphasic square Twenty-four hours postpartum, the second investiga-
tor asked participants to answer questions regarding
their satisfaction with the care provided. The satisfaction
level was measured with the Care in Obstetrics: Measure
for Testing Satisfaction (COMFORTS) scale. This scale
is a valid and reliable instrument to measure women’s
satisfaction with care during labour and the postpartum
period [24]. We obtained authorization for using the
Spanish version of the COMFORTS scale [25]. It is com-
posed of six subscales: confidence in newborn care, post-
partum nursing care, provision of choice, labour and
delivery nursing care, physical environment, and respect
for privacy. It includes 40 items which participants an-
swered with a 5-point Likert scale in agreement with
each statement where 1 = strongly disagree and 5 =
strongly agree. The calculation of the results applied to
the COMFORTS scale consists of 40 items, and each
Fig. 1 Electrode placement
one of them can be rated from 1 to 5 (1 = strongly
Báez-Suárez et al. Trials (2018) 19:652 Page 4 of 10

disagree and 5 = strongly agree); consequently, the max- group that obtained an improvement with clinically
imum final value is 200 and the minimum value is 40. A significant results (more than 1.3 cm of the VAS) was
level above 171 would be considered a high satisfaction the active TENS 2 group. Therefore, better results were
level [24]. obtained using high frequencies modified in time (80–
100 Hz), as well as a high pulse width (350 μs). However,
Statistical analysis a repeated measures test was analysed during the base-
Statistical calculations were performed using the IMB line and at 10 and 30 min after intervention (Table 4).
SPSS version 18.0 for Windows. The quantitative variables All anthropometric measures of the newborns are pre-
were presented as the mean ± standard deviation. The sented in Table 5. The mean values of newborn weight
qualitative variables were presented mediating the abso- and head circumference were not significantly different
lute frequencies. Statistical methods for analysing differ- between groups. No differences were observed in pain re-
ences between groups were one-way analysis of variance lief with regard to the newborn or mother anthropometric
(ANOVA) for continuous variables with normal distribu- or general characteristics. In all groups, all of the new-
tion, followed by the χ2 test for categorical variables, and a borns had Apgar scores > 7 by the first minute after birth,
Kruskal-Wallis test when the assumptions of one-way and all had normal scores by the fifth minute after birth.
ANOVA were not met. Statistical significance was defined To determine the overall satisfaction with the pro-
as p < 0.05. An external nurse to the obstetrics service en- gram, we used the COMFORTS scale. The one-way
tered the data and checked the devices to ensure that the ANOVA test results revealed differences among groups
dose administered was always the one programmed in with higher levels of satisfaction in the active TENS
each device. The data was analysed by a statistician who groups (active TENS 1, 175.1 ± 11.7; active TENS 2,
did not intervene in the clinical trial. 177.6 ± 11.3) compared with the TENS placebo group
(165.1 ± 9.2). No significant differences between the ac-
Results tive TENS groups were observed regarding the labour
No differences were found among the three groups re- experience and satisfaction with the care provided dur-
garding maternal age, weight, body mass index, gesta- ing labour. Regarding question 6, which refers to mea-
tional age, presentation, childbirth preparation course, sures to control pain during labour, participants showed
position adopted during labour, and kind of pushing a greater degree of satisfaction in the active TENS
during the third stage of labour (Table 1). Figure 2 groups versus the TENS placebo group (Fig. 3).
shows the progression of the participants throughout the No patients in any group reported adverse events such
trial. There were no dropouts during the study. The as skin allergy or burning at the electrode site.
baseline characteristics of the participants in each group With regard to the effectiveness of the blinding of the
are presented in Table 1. participants and the nurses, responses in the placebo
A significant association of VAS was detected depend- group were not significantly different from those of the
ing on the type of TENS over time. The initial pain level active TENS groups (p > 0.05), suggesting an adequate
of the active TENS 1 group had a mean of 7.4 ± 1.5, the blinding in all cases.
active TENS 2 group a mean of 8.1 ± 1.2, while the
TENS placebo group presented a mean of 6.6 ± 1.7 (p Discussion
< 0.05). The women of the TENS 2 group started with a The main purpose of this study was to evaluate the
higher level of pain, followed by the TENS 1 group, and pain-relieving effect of TENS during labour and to estab-
the TENS placebo group. The mean VAS pain scores in lish the most effective dose. VAS scores highlighted a de-
all the groups at different stages are shown in Table 2. crease in pain in the active TENS groups compared with
Therefore, to correct the possible effect that could be the placebo group. Moreover, the reduction in pain
generated when comparing pain at baseline with pain at reached the minimum clinically relevant difference. Re-
the end of the intervention, the analysis of covariance garding satisfaction, results also revealed better results in
(ANCOVA) method was used, detecting a significant asso- the active TENS groups than in the placebo group. No ad-
ciation between baseline and after 30 min (p < 0.001) as verse effects on the mothers or newborns were recorded.
well as with the type of treatment (p < 0.001). The global The findings of the present study in relation to our main
average considering the data of the three groups was 7.269 objective are similar to those of previous studies. Bundsen
(Table 3). et al. [26], Van der Spank et al. [7], and Chao et al. [8] re-
The between-group analysis highlighted a significant ported a significant reduction in pain intensity in the
decrease in pain, as measured on the VAS, at several TENS active group. However, the methods of those stud-
stages (baseline, 10 min, and 30 min later) in the active ies are very different from those of the present study.
TENS 2 group compared with the TENS 1 group and Bundsen et al. [26] used the TENS device interchangeably,
also compared with the TENS placebo group. The only placed on the lower back, on acupuncture points, and on
Báez-Suárez et al. Trials (2018) 19:652 Page 5 of 10

Table 1 Baseline participant characteristics and obstetric outcomes

Characteristic Group p
TENS 1 (n = 21) TENS 2 (n = 21) Placebo (n = 21)
Age (years) 28.3 ± 5.3 28.9 ± 6.0 27.1 ± 5.3 0.545*
Weight (kg) 72.9 ± 10.9 75.9 ± 12.6 71.5 ± 7.7 0.399*
BMI (kg/m2) 26.7 ± 2.9 28.7 ± 5.4 26.8 ± 1.6 0.745*
Presentation 0.714**
Cephalic-vertex 12 (19) 11 (17.5) 8 (12.7)
Cephalic-sinciput 5 (7.9) 3 (4.8) 5 (7.9)
Cephalic-brow 1 (1.6) 3 (4.8) 4 (6.3)
Cephalic-face 0 0 1 (1.6)
Breech 3 (4.8) 4 (6.3) 3 (4.8)
Gestational age (weeks) 39.5 ± 1.5 39.6 ± 1.5 39.3 ± 1.3 0.508*
Childbirth preparation course 0.446**
Yes 13 (20.6) 11 (17.5) 15 (23.8)
No 8 (12.7) 10 (15.9) 6 (9.5)
Length of first stage (min) 443 (216) 451 (238) 527 (225) 0.532*
Length of second stage (min) 42 (23.5) 40 (18.3) 38 (21.4) 0.722*
Position adopted during labour 0.319**
Sitting 3 (4.8) 3 (4.8) 1 (1.6)
Lateral decubitus 1 (1.6) 2 (3.2) 0
Dorsal decubitus 7 (11.1) 10 (15.9) 4 (6.3)
Dorsal decubitus and sitting 6 (9.5) 4 (6.3) 9 (14.3)
Lateral decubitus and sitting 2 (3.2) 0 3 (4.8)
Lateral and dorsal decubitus 2 (3.2) 2 (3.2) 4 (6.3)
Pushing methods for the second stage of labour 0.774**
Valsalva pushing 12 (19) 10 (15.9) 12 (19)
Spontaneous pushing 9 (14.3) 11 (17.5) 9 (14.3)
Perineal laceration 0.469**
None 1 (1.6) 1 (1.6) 0
Grade I 15 (23.8) 19 (30.2) 19 (30.2)
Grade II 4 (6.3) 1 (1.6) 2 (3.2)
Grade III 1 (1.6) 0 0
Accompanying person during the active phase of labour 21 (33.3) 21 (33.3) 21 (33.3) 1**
Data are presented as mean ± standard deviation or n (%)
TENS transcutaneous electrical nerve stimulation, BMI body mass index
*p values obtained from Kruskal-Wallis test and one-way analysis of variance tests
**p values obtained from χ2 test

other parts of the body. Van der Spank et al. [7] used dif- the TENS placebo group during the procedure, and it
ferent parameters during the TENS application: a fixed in- was clinically relevant in the active TENS 2 group.
ternal frequency of 80 Hz and a burst frequency of 2 Hz, Moreover, the reduction in pain reached the minimum
with a pulse duration of 275 μs, thus obtaining a reduction clinically relevant difference (1.3 points on the VAS), as
of 1.5 points on the VAS (lower than our results). Chao et was previously validated for Bernstein et al. [20], Galla-
al. [8] also used different parameters and applied it to spe- gher et al. [21], Todd et al. [22], and Santana et al. [23],
cific acupuncture points. who applied the same doses and localization TENS,
Our results in terms of quantification of pain reduc- obtaining an improvement that was almost double that
tion showed that there was a decrease in the patients’ of our study. A possible explanation for these findings
pain scores in the active TENS groups compared with may relate to individual pain perception, which in labour
Báez-Suárez et al. Trials (2018) 19:652 Page 6 of 10

Fig. 2 Consolidated Standards of Reporting Trials (CONSORT) flow diagram describing participant allocation in this study

depends on the intensity and duration of the contrac-

tions, the physical condition of the woman, as well as a
complexity of emotional factors, such as previous experi-
ences, present expectations, and cultural factors [27]. No
data on these characteristics were collected in our study.
Table 2 Pain visual analogue scale scores at different stages With regard to the TENS location, there is not a de-
Group finitive consensus to it being applied on the back (Bund-
Stage TENS 1 TENS 2 TENS placebo sen et al. [26], Van der Spank et al. [7], Santana et al.
Baseline 7.0 ± 1.5 8.1 ± 1.2 6.6 ± 1.7 [23]) or on acupuncture points (Bundsen et al. [26] and
Chao et al. [8]). The optimization of TENS depends on
10 min 6.2 ± 1.4 6.2 ± 2.0 8.3 ± 1.2
accurately selecting the electrode position, current wave-
30 min 6.3 ± 1.7 5.9 ± 1.9 8.8 ± 1.1
form, waveform duration, frequency, and intensity. Prior
Difference (95% CI) p* reports indicate that the greatest degree of pain reduc-
Baseline tion occurs when the electrodes are placed within the re-
TENS 1-TENS 2 −1.0 (− 2.2 to 0.1) 0.079 ceptive field for the nerve roots to alter nociceptive
TENS 1-Placebo 0.4 (− 0.7 to 1.6) 0.668 transmission in the dorsal horn of the spinal cord. In
our study, the electrodes were placed parallel to the
TENS 2-Placebo 1.5 (0.3 to 2.7) 0.009
spinal cord at the T10–L1 and S2–S4 levels (instead of
10 min
TENS 1-TENS 2 −0.4 (− 1.3 to 1.2) 0.995 Table 3 Adjustment of baseline pain level differences using the
TENS 1-Placebo −2.1 (− 3.3 to – 0.8) < 0.001 ANCOVA method
TENS 2-Placebo − 2.1 (− 3.3 to – 0.8) < 0.001 Group Mean error* Difference (95% CI)

30 min TENS 1 6.514a 0.300 5.913 to 7.115

a
TENS 1-TENS 2 0.4 (− 0.7 to 1.7) 0.646 TENS 2 5.382 0.315 4.750 to 6.013

TENS 1-Placebo − 2.4 (− 3.7 to − 1.5) < 0.001 Placebo 9.200a 0.308 8.583 to 9.816
Data are visual analogue scale (VAS) mean values
TENS 2-Placebo −2.9 (− 4.1 to − 1.6) < 0. 001
TENS transcutaneous electrical nerve stimulation, CI confidence interval
Data are visual analogue scale mean ± standard deviation scores unless *error values obtained from ANCOVA method
a
otherwise specified The covariates that appear in the model are evaluated with the following
TENS transcutaneous electrical nerve stimulation, CI confidence interval values: pain VAS at baseline = 7269. The dependent variable is VAS
*p values obtained from one-way analysis of variance after 30 min
Báez-Suárez et al. Trials (2018) 19:652 Page 7 of 10

Table 4 Repeated measures test for three measurements meaningful reduction in pain. Even in studies where there
(baseline, 10 min, and 30 min) are not significant differences in pain relief, many of their
Group (A) Time (B) Time Differences p* Difference participants have stated that they would prefer to use
(A – B) (95% CI) TENS for a future labour. A systematic review by Dow-
TENS 1 1a 2b 0.810 0.029 0.063 to 1.556 swell et al. [10] included 17 randomized, controlled trials
3c 0.667 0.135 − 0.136 to 1.469 comparing women receiving TENS during labour versus
2 1 −0.810 0.029 −1.556 to −0.063 routine care or placebo devices. The authors demon-
2 −0.143 1.000 −0.637 to 0.351
strated little difference in satisfaction with pain relief or in
pain ratings between the TENS and control groups.
3 1 −0.667 0.135 −1.469 to 0.136
Therefore, it seems reasonable to assume that the use of
2 0.143 1.000 −0.351 to 0.637 TENS may contribute to greater acceptance and more fre-
TENS 2 1 2 −1.857 > 0.001 1.111 to 2.603 quent use during delivery. In addition, the possibility of in-
3 2.238 > 0.001 1.436 to 3.040 cluding it within the process of routine care should be
2 1 −1.857 > 0.001 −2.603 to − 1.111 considered. Despite the results obtained, we must bear in
2 0.381 0.187 −0.113 to 0.875
mind that it is a subjective result susceptible to recall bias.
Another factor to take into account with TENS is the
3 1 −2.238 > 0.001 −3.040 to −1.436
accommodation factor. Patients of our study were
2 −0.381 0.187 −0.875 to 0.113 instructed to increase the TENS intensity to the maximum
Placebo 1 2 −1.762 > 0.001 −2.508 to − 1.016 non-painful level and to report if they perceived any de-
3 −2.190 > 0.001 −2.993 to −1.388 crease in their stimulus perception (which happens as a
2 1 1.762 > 0.001 1.016 to 2.508 result of nerve accommodation). We used high-frequency
2 −0.429 0.110 −0.922 to 0.065
TENS that randomly varied between 80 and 100 Hz. We
based this choice on evidence suggesting that delivering
3 1 2.190 > 0.001 1.388 to 2.993
random frequencies provides superior pain relief com-
2 0.429 0.110 −0.065 to 0.922 pared with a conventional fixed frequency [29]. It is con-
Data are visual analogue scale mean sidered that applying a stimulus with modulated or
TENS transcutaneous electrical nerve stimulation, CI confidence interval
*
p values obtained from repeated measures test alternating frequency reduces the accommodation suf-
a
b
Baseline fered by the nervous system against monotonous im-
After 10 min
c
After 30 min
pulses, since with the variation of frequencies the stimulus
that the patient is receiving varies continuously [30–32].
placing them on acupuncture points) to stimulate the Santana et al. [23] used a constant frequency of 100 Hz,
nerve roots at the dermatomal level, corresponding to observing a significant improvement in pain relief with an
the whole uterus. Saxena et al. [28] compared the effi- application time of 30 min. However, it was observed that
cacy of TENS administered by dermatomal stimulation if there was a significant improvement in the degree of
with TENS administered by stimulation of acupuncture. pain at 15 min, but at 30 min it began to rise, it was prob-
In their study, TENS administration by dermatomal ably the result of the accommodation effect.
point stimulation provided early onset and better pain With regard to the TENS pulse width, Santana et al.
relief in labour. However, it is important to note that au- [23] applied 100 μs. In our study, we selected 350 micro-
thors who applied TENS at acupuncture points seconds because it has been observed that the increase
recognize that the physiological mechanisms whereby of the duration of the pulse in 250 microseconds can
TENS can relieve pain are uncertain. produce more analgesic effects [33].
In our study, satisfaction was significantly higher in The use of TENS during labour has advantages and
the TENS active groups because this intervention re- disadvantages. Advantages of TENS includes non-inva-
sulted in a statistically significant and clinically siveness, easy application, no interference with maternal

Table 5 Anthropometric measures of the newborns

Characteristics of the Group p*
newborn
TENS 1 (n = 21) TENS 2 (n = 21) TENS placebo (n = 21)
Weight (g) 3303.0 ± 367.7 3176.1 ± 366.2 3172.8 ± 453.1 0.485
Height (cm) 47.9 ± 1.8 47.5 ± 1.7 48.6 ± 1.6 0.127
Cranial perimeter (cm) 34.7 ± 1.7 33.8 ± 2.0 33.9 ± 1.6 0.254
Data are mean ± standard deviation or n unless otherwise specified
TENS transcutaneous electrical nerve stimulation
*p values obtained from Kruskal-Wallis test
Báez-Suárez et al. Trials (2018) 19:652 Page 8 of 10

Fig. 3 COMFORTS scale. Question 6: Measures to control pain during labour. TENS transcutaneous nerve stimulation

consciousness or mobility, safety, and freedom from any A further major weakness of our study was that we did
significant side effects [7, 34, 35]. However, there are some not evaluate patient anxiety, in spite of its potential role as
indirect side effects that result from the use of neuraxial a confounding factor in studies on pain reduction interven-
anaesthesia that can be underestimated. These may in- tions. Women during labour experience significant levels
clude, for example, longer first and second stages of of anxiety with repercussions on pain perception and satis-
labour, an increased incidence of foetal malposition, and faction. Psychological variables are also likely to play a role.
increased use of oxytocin and instrumental vaginal deliv- Anxiety and depression have been considered from a
eries. In this context, there are not sufficient studies that physiological standpoint, but they are also likely to affect
describe the relationship between TENS and lacerations. maternal behaviour during the birth. Maternal anxiety is
Tischendorf et al. [36] describes an incidence of episiot- associated with lower self-efficacy and confidence, a greater
omy or lacerations of 52%, and we found in our study an perceived threat, and increased pessimism [37–39].
87% incidence of superficial vaginal tears, which would be Mothers who are in pain prenatally may be more anxious
treated by nurses, and a 12.7% incidence of grade II–III of the birth experience and enter childbirth with an
lacerations. There were no differences between the groups increased level of physiological arousal as a consequence of
with or without active TENS. Tischendorf et al. [36] also both the pain they are experiencing and the psychological
suggested that the reduction of pain achieved through implications. Increased physiological arousal during labour
TENS could promote lacerations. has also been associated with reducing contractions and
On the other hand, TENS represents an alternative increasing the duration of labour and foetal distress, thus
method in pain relief for those women who wish to increasing the likelihood of an intervention. In the context
have a natural delivery and when epidural analgesia is of mothers who have prenatal pain may be more anxious
not available or contraindicated. According to this about the experience of childbirth, for this reason we talk
idea, the review of Bedwell al. [9] argued that some about offering a pre-labor experience with less pain. Since
women wish to have methods to enable them to cope the TENS is an economical and easy-to-use device, its use
with pain, which they see as an integral and necessary could be taught to women for their use at home.
part of labour. Nevertheless, our results are not
without their own limitations. We did not compare Conclusions
TENS with other non-pharmacological pain relief TENS is a non-pharmacologic, effective, and safe option
methods. for pain relief during labour. With the use of high
Báez-Suárez et al. Trials (2018) 19:652 Page 9 of 10

frequencies modified in time (80–100 Hz) as well as a 3. Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, et al. Pain
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Funding Database Syst Rev. 2009;(2):CD007214. https://doi.org/10.1002/14651858.
This research received no specific grant from any funding agency in the CD007214.pub2.
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revised it critically for important intellectual content. JGA was involved in Beerens L. Pain relief in labour by transcutaneous electrical nerve
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Universitario Insular Materno Infantil Research Ethics Committee (CEIm- stimulation (TENS) can reduce postoperative analgesic consumption. A
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invited to participate. All patients signed an informed consent statement
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Consent for publication
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All subjects who participated in the image acquisition signed a consent
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form. The patients agreed that their information in this study could be
20. Bernstein SL, Bijur PE, Gallagher EJ. Relationship between intensity and relief
revealed for publication. Signed consent forms from the patients in this
in patients with acute severe pain. Am J Emerg Med. 2006;24:162–6.
study are kept in the author’s institution and are available for review upon
21. Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically
request from the Editor-in-Chief.
important changes in pain severity measured on a visual analog scale. Ann
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Competing interests
22. Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported
The authors declare that they have no competing interests.
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23. Santana LS, Gallo RB, Ferreira CH, Duarte G, Quintana SM, Marcolin AC.
Publisher’s Note Transcutaneous electrical nerve stimulation (TENS) reduces pain and
Springer Nature remains neutral with regard to jurisdictional claims in postpones the need for pharmacological analgesia during labour: a
published maps and institutional affiliations. randomised trial. J Physiother. 2016;62(1):29–34.
24. Janssen PA, Dennis CL, Reime B. Development and psychometric testing of
Received: 26 February 2018 Accepted: 1 November 2018 The Care in Obstetrics: Measure for Testing Satisfaction (COMFORTS) scale.
Res Nurs Health. 2006;29(1):51–60.
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