| CTRI Number |
CTRI/2026/01/100173 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
POSITIVE EFFECT OF FOOT REFLEXOLOGY AND MUSIC THERAPY TO WOMEN IN LABOUR FOR POSITIVE LABOUR OUTCOME |
|
Scientific Title of Study
|
“A Randomized Controlled Trial Assessing the Effects of Specific Intranatal Complementary Therapies on Anxiety Level and Obstetric Outcome Among Parturient Mothers Admitted at Selected Tertiary Care Hospital, Vadodara, Gujarat” |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Mittal Panchal |
| Designation |
Assistant Professor |
| Affiliation |
Sumandeep Nursing College |
| Address |
Sumandeep vidhyapeeth, Nursing department, Waghodia road, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9009500791 |
| Fax |
|
| Email |
mittalhardik1521@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vruti Patel |
| Designation |
Associate Professor |
| Affiliation |
Sumandeep Nursing College |
| Address |
Sumandeep vidhyapeeth, Nursing department, Waghodia road, Vadodara, Gujarat.
26- B, SHARNAM LIFESTYLE,WAGHODIA ROAD
Vadodara
GUJARAT
391760
India |
| Phone |
9009500791 |
| Fax |
|
| Email |
vrutipatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Mittal Panchal |
| Designation |
Assistant Professor |
| Affiliation |
Sumandeep Nursing College |
| Address |
Sumandeep vidhyapeeth, Nursing department, Waghodia road, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9009500791 |
| Fax |
|
| Email |
mittalhardik1521@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ms Mittal Panchal |
| Address |
Sumandeep vidhyapeeth, Nursing department, Waghodia road, Vadodara, Gujarat. |
| 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 |
| Ms Mittal Panchal |
Dheeraj hospital |
Sumandeep vidhyapeeth, dheeraj hospital, Waghodia road, Vadodara, Gujarat.
Vadodara
GUJARAT |
09009500791
mittalhardik1521@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeepvidhyapeethinstitutionalethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Parturient mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. MUSIC THERAPY
2. FOOTREFLEXOLOGY THERAPY |
BOTH THERAPIES WILL APPLY ACCODINGLY FOR 20 MINUTES STEPWISE. |
| Intervention |
Music therapy and foot reflexology therapy |
providing therapy to the parturient mothers for 20 minutes |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
parturient mothers admitted at tertiary care hospital of Vadodara, Gujarat and with term gestational week (37-42), spontaneous labor, cephalic presentation of the foetus. |
|
| ExclusionCriteria |
| Details |
The parturient mothers who having medical problem or pregnancy related complication, high risk pregnancy, conceived after treatment of infertility and short stature mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFECTIVENESS OF FOOT REFLEXOLOGY THERAPY ON ANXIETY AND OBSTETRIC OUTCOME |
4 to 8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EFFECTIVENESS OF MUSIC THERAPY ON ANXIETY AND OBSTETRIC OUTCOME |
4 TO 8 HOURS |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
Final Enrollment numbers achieved (Total)= "156"
Final Enrollment numbers achieved (India)="156" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2026 |
| Date of Study Completion (India) |
15/12/2025 |
| Date of First Enrollment (Global) |
13/01/2026 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Preparing article for publication. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
I have used two interventions for parturient mothers. for experimental group 1 - applied Music therapy with free positions and for Experimental group 2- applied foot reflexology therapy. for each intervention researcher took 20 minutes. Data collection is completed now. Data analysis and interpretation found both interventions were effective but music therapy is more effective as compared to foot reflexology. |