| CTRI Number |
CTRI/2026/03/105710 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
evaluate the effect of hand and foot massage on pain, sleep, and anxiety in post-caesarean mothers. |
|
Scientific Title of Study
|
Assess the Effectiveness of Hand And Foot Massage on Incisional Pain, Sleeping Pattern and Anxiety Among Post Caesarean Mothers Admitted In Selected Hospitals.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Pandav |
| Designation |
post graduate student |
| Affiliation |
Datta Meghe Institute of higher Education And Research |
| Address |
Department of Obstetric And Genecology Nursing Rmt Radhikabai Meghe Memorial collage of nursing Sawangi Meghe wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9588662736 |
| Fax |
|
| Email |
pujapandav2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Moon |
| Designation |
Assistant Professor Of OBGY Nursing |
| Affiliation |
Datta Meghe Institute of higher Education And Research |
| Address |
Department Of OBGY Nursing Smt
Radhikabai Meghe Memorial collage of nursing Sawangi Meghe wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970814240 |
| Fax |
|
| Email |
Moonshalini@Gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Moon |
| Designation |
Assistant Professor Of OBGY Nursing |
| Affiliation |
Datta Meghe Institute of higher Education And Research |
| Address |
Department Of OBGY Nursing Smt
Radhikabai Meghe Memorial collage of nursing Sawangi Meghe wardha
MAHARASHTRA
442001
India |
| Phone |
9970814240 |
| Fax |
|
| Email |
Moonshalini@Gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of higher Education And Research Sawangi Meghe Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of higher Education And Research |
| Address |
Sawangi Meghe Wardha India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Pooja Pandav |
Acharya Vinobha Bhave Rural Hospital |
Department of Obstetrics and Gynecology, Ground floor AVBRH Building, Sawangi, Meghe, Wardha, India 442001
Wardha
MAHARASHTRA |
9588662736
pujapandav2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Education And Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hand and food massage on incisional pain sleeping pattern and anxiety among post caesarean mothers |
Hand and food massage on incisional pain sleeping pattern and anxiety among post caesarean mothers to promote relaxation, reduce pain at the incision site, improve sleep quality, and lower anxiety levels. intervention will be from 14 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Post-caesarean mothers are in 1st, 2nd and 3rd post-operative day
2 Post-caesarean mothers are willing to participate in the study
3 Post-caesarean mothers understand Marathi, Hindi and English.
|
|
| ExclusionCriteria |
| Details |
1 Associated post caesarean complications eg. Infection, Surgical injury to bladder or intestines,
2 Amniotic fluid embolism (Amniotic fluid or fetal material enters the maternal bloodstream), Inflammation of the uterus, Bleeding.
3 Mother who are mentally ill.
4 Mothers who are severely ill
5 Those mothers already participated in this type of study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome showed that hand and foot massage significantly reduced incisional pain, improved sleep quality, and lowered anxiety levels among post-Caesarean mothers. Mothers who received the massage reported faster physical recovery and better emotional well-being compared to those who did not.
|
Primary timepoints for data collection were set at baseline (before the first massage session) and after each daily massage during the intervention period. A final assessment was conducted at the end of the 5-day intervention to evaluate overall changes in incisional pain, sleep pattern, and anxiety. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome included improved maternal satisfaction with postnatal care and enhanced bonding with the newborn. Participants also reported feeling more relaxed and supported during their hospital stay. |
Secondary outcomes were measured at the end of the intervention period (day 5) and during discharge. Follow-up feedback was also collected through a short interview or questionnaire before leaving the hospital. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2026 |
| 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 study aimed to assess the effectiveness of hand and foot massage on incisional pain, sleeping pattern, and anxiety among post-Caesarean mothers in selected hospitals. A structured intervention involving daily 15–20 minute massages was given for 3–5 days post-surgery. Results showed significant reduction in pain, improved sleep quality, and decreased anxiety levels in the intervention group compared to those who received standard care. The findings suggest that hand and foot massage is a simple, non-invasive, and effective supportive therapy for enhancing recovery in post-Caesarean mothers. |