FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045994 [Registered on: 28/09/2022] Trial Registered Prospectively
Last Modified On: 28/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [MUSIC THERAPY]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   a study to assess the effectiveness of music therapy on anxiety and pain in labour women. 
Scientific Title of Study   Effectiveness of music therapy on reduction of anxiety and pain perception in parturient mothers admitted for labour at JIPMER- A Randomized control trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  varna mohan 
Designation  MSc Obstetric and gynecology Nursing student 
Affiliation  College of Nursing, JIPMER, Puducherry  
Address  Jawaharlal Institute of Postgraduate Medical Education and Research. MSc Nursing Obstetric and gynaecology Nursing department, college of nursing,JIPMER,Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8075909368  
Fax    
Email  varnamoha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Kanimozhi K 
Designation  Tutor 
Affiliation  College of Nursing, JIPMER, Puducherry 
Address  Department of Obstetric and gynecology Nursing. College of Nursing, Jawaharlal Institute of Postgraducate Medical Education & Research, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8940865962  
Fax    
Email  kanibaskar@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Mrs Kanimozhi K 
Designation  Tutor 
Affiliation  College of Nursing, JIPMER, Puducherry 
Address  Department of Obstetric and gynecology Nursing. College of Nursing, Jawaharlal Institute of Postgraducate Medical Education & Research, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8940865962  
Fax    
Email  kanibaskar@yahoo.in  
 
Source of Monetary or Material Support  
INTRAMURAL FUND COMMITTEE,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY-605006 
 
Primary Sponsor  
Name  INTRAMURAL FUND 
Address  INTRAMURAL FUND COMMITTE , JIPMER,PUDUCHERRY-605006 
Type of Sponsor  Research institution and hospital 
 
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 
Mrs KANIMOZHI K  JIPMER  CLEAN LABOUR ROOM, GROUND FLOOR, WCH, JIPMER, PUDUCHERRY, 605006
Pondicherry
PONDICHERRY 		 8940865962

kanibaskar@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITEE FOR HUMAN STUDIES, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Music therapy  In the Intervention Group, the Parturient mother will listen to the type of music individualized according to the choice of a mother for 30min using Bluetooth. Music therapy will be provided uniformly to all mothers after 4-5cm cervical dilatation for a minimum of 3 times. Baseline anxiety and pain perception of selected parturient mothers will be assessed using C.D Speilberger’s scale of state-trait anxiety inventory and Numerical pain intensity scale respectively. Pain perception is assessed intermittently after each set of music therapy. After completion of music therapy, post test anxiety level and pain perception will be assessed. 
Comparator Agent  nil  The parturient mother in the control group will receive regular standard care inj Tramadol 50mg IM. Baseline anxiety and pain perception of selected parturient mothers will be assessed using C.D Speilberger’s scale of state-trait anxiety inventory and Numerical pain intensity scale respectively. Pain perception is assessed in half an hour interval twice. In the end, post-test anxiety level and pain perception of parturient mothers will be assessed again. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Primipara mother of singleton pregnancy at term admitted with cervical dilatation of 4 - 5 cm or more in labour room. Mother who are provided with standard routine care of inj Tramadol 50mg IM during labour and are planned to undergo spontaneous vaginal delivery. Mother with no medical and obstetrical co-morbidities. 
 
ExclusionCriteria 
Details  Mother is not willing to participate and the Mother with hard of hearing or hearing impairment.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of music therapy on labour pain and anxiety in parturient mother.   3hour 
 
Secondary Outcome  
Outcome  TimePoints 
nil  0 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   30/09/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study is a randomized control trial to know the effectiveness of music therapy on reduction of anxiety and pain perception of parturient mother admitted in JIPMER. Parturient mothers who are willing and  meet the criteria  will be randomly assigned to either the experimental group or control group.The background demographic and clinical data will be obtained using semi-structured interview and record review. Preference of music will be assessed through semi-structured interview from experimental mother at the time of admission. All the parturient mothers will receive Inj Tramadol 50mg IM as standard routine care, additionally experimental group will  listen to type of music individualized according to the choice of mother  for 30min using bluetooth. Music therapy will be provided uniformally to all mothers after 4-5cm cervical dilatation for minimum 3 times. These musics will be validated by experts from the field of music, obstetrics and field of nursing. Baseline anxiety and pain perception of parturient mothers of both the group will be assessed  using C.D Speilberger’s scale of state trait anxiety inventory and Numerical pain intensity scale respectively. Pain perception is assessed intermittently after each set of music therapy. After completion of music therapy, post test anxiety level and pain perception of parturient mothers of both group will be  assessed .

 
Close