| CTRI Number |
CTRI/2025/10/096282 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Testing a Nerve Stimulation Device Compared to a Fake Device to Reduce Labor Pain in Pregnant Women During Early Childbirth |
|
Scientific Title of Study
|
he Efficacy of Transcutaneous Electrical Nerve Stimulation
(TENS) for Pain Relief During First Stage of Labor- A single
blinded randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Paritosh Gupta |
| Designation |
junior resident |
| Affiliation |
AIIMS Raipur |
| Address |
3rd floor dept of ob and gyn
aiims raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
07007628387 |
| Fax |
|
| Email |
gupta.paritosh3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita Agrawal |
| Designation |
Professor and Head |
| Affiliation |
AIIMS Raipur |
| Address |
3rd floor Dept of Obs and Gynae
AIIMS RAIPUR
Raipur
CHHATTISGARH
492099
India |
| Phone |
08518881744 |
| Fax |
|
| Email |
drsaritaagrawal@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paritosh Gupta |
| Designation |
PG student |
| Affiliation |
AIIMS Raipur |
| Address |
3rd floor dept of obs and gyane
aiims raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
07007628387 |
| Fax |
|
| Email |
gupta.paritosh3@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Paritosh Gupta |
| Address |
3rd floor dept of obgyn aiims raipur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Paritosh |
AIIMS Raipur |
1st floor labour room ,AIIMS Raipur, CG
Raipur
CHHATTISGARH |
7007628387
gupta.paritosh3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham TENS Device |
Participants in the control group will receive an identical-appearing sham TENS unit with inactive electrical output, applied at the same spinal levels (T10–L1 and S2–S4) using identical electrodes and placement method.
This ensures participant blinding and controls for placebo effects. |
| Intervention |
TENS device |
Participants in the intervention group will receive TENS therapy using a portable battery-operated device. Two pairs of flat electrodes (5 x 9 cm) will be placed paravertebrally—1 cm lateral to the spine—at the T10 to L1 and S2 to S4 dermatomal levels, which correspond to the uterine, cervical, and perineal sensory pathways.
Continuous low-intensity electrical impulses (frequency 16–120 Hz, pulse duration 100–150 microseconds) will be delivered. The intensity will be adjusted according to maternal comfort under supervision of labour room staff. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Primigravida Women
2. Singleton pregnancy
3. Gestational Age more than equal to 37 weeks
4. Cephalic Presentation
5. Women in active first stage of labour with (where in active labour is defined as cervical dilatation more than equal to 4cm with adequate uterine contractions)
|
|
| ExclusionCriteria |
| Details |
1. Pregnancies with Medical complications such as heart disease, renal disease, psychiatric disease, seizure disorders
2. Antepartum haemorrhage
3. Cephalopelvic disproportion
4. Precipitate labour
5. Previous history of caesarean section or myomectomy
6. Women who received any other method of analgesia before entering to study.
7. Skin lesion at the site of application of TENS patch
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain index and percentage of pain relief before and after the intervention |
during the first stage of labour (20 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Duration of first stage of labour
• Mode of delivery
• Neonatal outcome:
• APGAR score at birth & at 5 minutes
• Need for resuscitation
• NICU admissions
• Any side effects- rashes at the site
• Patient satisfaction
|
during first stage of labour 20 hours max |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Scientific Title
The Efficacy of Transcutaneous Electrical Nerve Stimulation TENS for Pain Relief During the First Stage of Labor A Single Blind Randomised Controlled Trial
Public Title
Evaluation of TENS Transcutaneous Electrical Nerve Stimulation for Labour Pain Relief in Women During the First Stage of Labour
Background or Brief Summary
Labour pain is one of the most intense physiological experiences for women. Non pharmacological options for pain relief are gaining importance due to their safety and ease of use. Transcutaneous Electrical Nerve Stimulation TENS delivers mild electrical impulses through the skin to modulate pain transmission by stimulating large sensory fibres and promoting natural endorphin release. Previous studies have shown mixed results. This study aims to provide clear evidence on the efficacy and safety of TENS for labour pain relief compared to a sham device.
Study Design
Single blind randomised controlled parallel group clinical trial conducted at the Department of Obstetrics and Gynaecology All India Institute of Medical Sciences AIIMS Raipur
Participants
Primigravida women aged 18 years and above with singleton cephalic pregnancies at 37 weeks or more in active first stage of labour with cervical dilatation of 4 cm or more
Sample size 70 participants 35 per group calculated for 80 percent power and 5 percent significance level
Intervention
Study Group Active portable TENS device applied at T10 to L1 and S2 to S4 dermatomal levels
Control Group Sham inactive TENS device
Both groups will receive standard obstetric care as per WHO labour care guidelines
Primary Outcome
1 Reduction in pain intensity measured using Visual Analogue Scale and Pain Index
2 Requirement of pharmacological analgesia
Secondary Outcomes
Duration of first stage of labour
Mode of delivery
Maternal satisfaction score
Neonatal outcomes Apgar score at 1 and 5 minutes need for resuscitation NICU admission
Adverse effects such as rash or burn
Duration
Total study duration 24 months including 18 months for recruitment and 6 months for data analysis and report preparation
Expected Outcome
The study aims to determine whether TENS is an effective safe and satisfactory non pharmacological method for labour pain relief and to support evidence based obstetric analgesia guidelines |