| CTRI Number |
CTRI/2026/01/100725 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Receptive Music Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial to see the effect of music therapy on labor and delivery in first time pregnancies |
|
Scientific Title of Study
|
Effect Of Receptive Music Therapy On Labor and Delivery In Nulliparous Singleton Pregnancies - Randomized Control Study |
| 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 Anupama Gupta |
| Designation |
Post Graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9958108752 |
| Fax |
|
| Email |
ag1998jan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi M Gupta |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi.
Central
DELHI
110002
India |
| Phone |
9968604351 |
| Fax |
|
| Email |
drmadhavimg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi M Gupta |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi.
Central
DELHI
110002
India |
| Phone |
9968604351 |
| Fax |
|
| Email |
drmadhavimg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi DELHI 110002 India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 |
| Type of Sponsor |
Government 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 Anupama Gupta |
Maulana Azad Medical College |
Department of obstetrics and gynaecology,Maulana Azad Medical College, Bahadur Shah zafar Marg
New Delhi
DELHI
Central
DELHI |
9958108752
ag1998jan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Receptive Music Therapy |
Laboring women in latent phase of labor will be screened and who fulfill the inclusion criteria will be recruited. All the participants will be included in the study after written informed consent about the study and music intervention. Eligible participants will be randomly allocated by opaque sealed envelope in a 1:1 ratio to either music during labor or control group. In Music Group ( Group II ) preselected music ( Raag Hamsadhwani and Beethoven s Ode to joy ) will be played ( through noise cancelling headphones, alternately) once the active phase of labor ( more than or equal to 5 cm cervical dilatation ) is established until full dilatation. The music will be played in a continuous loop of 60 minutes with 10 minutes break every 60 minutes. In that 10-minute break VAS score for pain and anxiety will be assessed. Labor progress and demand for analgesia will be noted in both groups. Outcomes will be noted at full dilatation.
Once delivery is completed: Postpartum assessment of VAS score for pain and anxiety (at 1hr and 24hr) will be done and acceptability for future labor and child birth will be ascertained. |
| Comparator Agent |
Standard Care |
Women in group I will receive routine obstetrical care as per hospital protocol , including the use of noise cancelling headphones to reduce the background noise that can promote anxiety. Every 60 minute: VAS score for pain and anxiety will be assesed. Labor progress and demand for analgesia will be noted in both groups. Outcomes will be noted at full dilatation.
Once delivery is completed: Postpartum assessment of VAS score for pain and anxiety (at 1hr and 24hr) will be done and acceptability for future labor and child birth will be ascertained. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Nulliparous women
2. Age: 18-40 yrs
3. Low risk singleton pregnancies, vertex presentation.
4. 37-41 weeks period of gestation.
5. Spontaneous labor |
|
| ExclusionCriteria |
| Details |
1. Women with hearing impairment.
2. Women with known severe anxiety disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean pain level during the active phase of labor, assessed by VAS ( Visual Analogue scale ) for pain. |
From establishment of active phase of labor ( more than or equal to 5 cm cervical dilatation ) until full dilatation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean Pain level during the second stage, and at post partum, assessed by VAS for pain.
2. Duration of second stage of labor.
3. Mean anxiety level during the active phase of labor, second stage, and at post partum, assessed by VAS for anxiety.
4. Use of analgesics.
5. Acceptability for future labor and child birth. |
From establishment of active phase of labor ( more than or equal to 5 cm cervical dilatation ) until full dilatation.
Post partum assessment of VAS score for pain and anxiety ( at 1hr and 24hr) . |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
19/01/2026 |
| 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 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
|
The primary purpose of this study is to evaluate the effect of receptive music therapy as a non-pharmacological intervention on the intensity of perceived labor pain and anxiety among nulliparous women with singleton pregnancies during labor, and to assess its impact on labor and delivery outcomes when compared to routine intrapartum care. Study hypothesis Receptive music therapy during labor reduces perceived pain and anxiety levels and improves labor outcomes in nulliparous singleton pregnancies. |