| CTRI Number |
CTRI/2024/12/077792 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF MUSIC THERAPY ON MATERNAL STRESS LEVELS AND VOLUME OF EXPRESSED BREAST MILK |
|
Scientific Title of Study
|
EFFECT OF MUSIC THERAPY ON MATERNAL STRESS LEVELS AND VOLUME OF EXPRESSED BREAST MILK – A PILOT 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 |
Himang Bhardwaj |
| Designation |
Junior Resident |
| Affiliation |
JNMCH AMU |
| Address |
Department of Paediatrics JNMCH AMU Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7351604565 |
| Fax |
|
| Email |
Hbhardwaj3792@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Uzma Firdaus |
| Designation |
Professor |
| Affiliation |
JNMCH AMU |
| Address |
Department of Paediatrics JNMCH AMU Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9837122711 |
| Fax |
|
| Email |
Druzmafirdaus@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Himang Bhardwaj |
| Designation |
Junior Resident |
| Affiliation |
JNMCH AMU |
| Address |
Department of Paediatrics JNMCH AMU Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7351604565 |
| Fax |
|
| Email |
Hbhardwaj3792@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Himang Bhardwaj
Jr1 Department of Paediatrics
Jnmch AMU ALIGARH UP India 202001 |
|
|
Primary Sponsor
|
| Name |
Dr Himang Bhardwaj |
| Address |
Department of Paediatrics JNMCH AMU Aligarh |
| 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 Himang Bhardwaj |
Neonatal Intensive Care Unit |
Side Room Division of Neonatology Department of Paediatrics JNMCH AMU Aligarh
Aligarh
UTTAR PRADESH |
7351604565
Hbhardwaj3792@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Regd.),Jawaharlal Nehru Medical College and Hospita |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z391||Encounter for care and examinationof lactating mother, (2) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Music Therapy |
Baselines Volume of Expressed Breast Milk and Salivary cortisol levels taken before Music therapy at 6 am of same patient and Baseline Volume of Expressed Breast Milk and Salivary Cortisol level of control at 6am and 8 am |
| Intervention |
Music Therapy |
Music Therapy is given for 30 minutes through earpods at 8 before Expression of Breast Milk and post music Salivary Cortisol |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Mother along with the preterm newborns admitted in Neonatal Intensive care unit. |
|
| ExclusionCriteria |
| Details |
Sick Mothers or mothers taking any drugs which are contraindicated during lactation. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the effect of music therapy on reducing stress level in lactating mothers.
2.To determine the effect of music therapy on augmenting the volume of expressed breast milk and maternal stress hormone |
Early Morning (6am-9am) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the maternal and neonatal factors affecting the milk output. |
Early Morning (6am-9am) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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="2"
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
|
This pilot randomized control trial will include 80 newborn mother dyads, 40 each in the intervention and the control group. A written informed consent will be sought from the parents/legal guardian. The details of newborn history, finding of clinical examination and results of investigation will be recorded in the predesigned proforma. Maternal and family characteristics, ANC details and birth related history, comorbid conditions, physical characteristics and investigation results will be meticulously enquired and entered in the proforma. Block randomization including blocks of 4 will be utilized for recruitment of subjects in the two arms. For expression of milk in the control group, the mother will be made to sit in the designated area for 10 minutes after which expression of milk will be done by aseptic measures. For the study group, the mother will be seated in the same place and will be made to listen to a preselected light instrumental music with the help of earpods for 30 minutes. The expression of milk will be done after 20 minutes while she still keeps listening to the music adopting the same procedure as previously mentioned. The volume of milk expressed will be quantified and fed to the baby as advised by the treating neonatologist. The trial will commence after obtaining the registration from CTRI |