FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105406 [Registered on: 05/03/2026] Trial Registered Prospectively
Last Modified On: 04/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Deep Breathing, Progressive Muscle Relaxation Techniques]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of deep breathing and muscle relaxation techniques on labour pain and childbirth experience among first-time pregnant mothers visiting labour room in IMS & SUM Hospital of Bhubaneswar Odisha. 
Scientific Title of Study   The effect of psychoeducation on pain perception and labour experience among mothers visiting labour room in IMS & SUM Hospital of Bhubaneswar, Odisha. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayushi De 
Designation  M.Sc. Nursing 
Affiliation  SUM Nursing College 
Address  SUM Nursing College, Department of Obstetrics and Gynaecological Nursing, Siksha O Anusandhan University, Kalinga Nagar, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  9734574407  
Fax    
Email  ayushide09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. (Dr.) Pravati Tripathy 
Designation  Director 
Affiliation  SUM Nursing College 
Address  SUM Nursing College, Department of Obstetrics and Gynaecological Nursing, Siksha O Anusandhan University, Kalinga Nagar, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  9437035927  
Fax    
Email  pravatitripathy@soa.ac.in  
 
Details of Contact Person
Public Query  
Name  Ayushi De 
Designation  M.Sc. Nursing 
Affiliation  SUM Nursing College 
Address  SUM Nursing College, Department of Obstetrics and Gynaecological Nursing, Siksha O Anusandhan University, Kalinga Nagar, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  9734574407  
Fax    
Email  ayushide09@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Ayushi De 
Address  SUM Nursing College, Department of Obstetrics and Gynaecological Nursing, Siksha O Anusandhan University, Kalinga Nagar, Bhubaneswar 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ayushi De  IMS & SUM Hospital  Department of Obstetrics and Gynaecology Labour Room IMS & SUM Hospital Siksha O Anusandhan University Kalinga Nagar Bhubaneswar
Khordha
ORISSA 		 9734574407

ayushide09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant Mothers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Deep Breathing, Progressive Muscle Relaxation Techniques  The intervention consists of two structured psychoeducation sessions during late pregnancy and a short booster at admission. In Week 1, mothers receive an introduction that includes consent, baseline assessment, explanation of labour stages and pain, coping methods, partner roles, and training in deep breathing and progressive muscle relaxation (PMR). In Week 2, the focus shifts to addressing fears, coping statements, guided imagery, partner support skills such as massage and encouragement, and demonstrations of labour positions, followed by combined relaxation practice. On admission to the labour room (38–40 weeks), mothers are given a quick revision of breathing, PMR, and coping techniques, along with reassurance, to reinforce confidence and preparedness for labour. The total duration of the intervention is 2 weeks during late pregnancy, with one introductory session in week 1 and one reinforcement session in week 2, followed by a brief booster guidance during the early stage of labour. 
Comparator Agent  Routine Antenatal Care  Participants in the control group will receive routine standard care provided in the hospital, including monitoring of labour progress, supportive nursing care, and standard obstetric management without any additional psychoeducation intervention. Participants in the control group will receive routine antenatal care provided in the hospital without any additional intervention. The total duration of the routine antenatal care is 2 weeks during late pregnancy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Pregnant women who are hospitalised for induction of labour or ruptured membranes without onset of contractions.
2. Women who can understand and communicate in the local language (Odia) as applicable.
3. Women who are willing to participate, provide written informed consent, and are ready to attend at least 2 sessions.
4. Women who are decide to delivery in this hospital, available for follow-up until the postpartum data collection period.
 
 
ExclusionCriteria 
Details  1. Pregnant women who delivered by instrumental vaginal delivery (e.g. vacuum forcep) or caesarean section after pain scoring was performed.
2. Women with high-risk pregnancies (e.g., severe pre-eclampsia, placenta previa with bleeding, severe cardiac disease) that may affect safe participation.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in pain perception and labour experience scores among primi mothers following psychoeducation intervention, assessed using a standardized Pain Perception Scale during labour and Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ Version A and B) for labour experience, in both experimental and control groups  Change in pain perception and labour experience scores among parturient mothers following psychoeducation intervention, assessed using a standardized Pain Perception Scale during labour and Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ Version A and B) for labour experience, in both experimental and control groups. Baseline assessment will be done during late pregnancy before intervention and outcome assessment will be done within 24 hours of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   N/A 
Date of First Enrollment (India)   02/04/2026 
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 Yet Recruiting 
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   This randomized controlled trial aims to evaluate the effect of structured psychoeducation on pain perception and childbirth-related expectancy and experience among parturient mothers admitted to the labour room of IMS and SUM Hospital, Bhubaneswar, Odisha. A total of 84 participants will be recruited and randomly allocated into experimental (n = 42) and control (n = 42) groups. The experimental group will receive structured psychoeducation, including information on labour process, coping strategies, breathing and relaxation techniques, while the control group will receive routine standard care. Pain perception will be assessed using a standardized Pain Perception Scale at baseline before intervention and and within 24 hours after delivery, and childbirth expectancy and experience will be assessed using Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ Version A and B). Data will be collected at baseline, and within 24 hours after delivery. The findings of the study are expected to provide evidence on the effectiveness of psychoeducation in improving maternal labour outcomes 
Close