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CTRI Number  CTRI/2025/01/078872 [Registered on: 16/01/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Music therapy Tactile stimulation visual stimulation aromatherapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Different sensory stimulus such as touch, music, visual and smell will be provided and checked whether it affects the mother-infant and mother-unborn child bonding  
Scientific Title of Study   Effect of multi-sensory stimulation on antepartum and postpartum maternal bonding among primigravida women in a selected tertiary care hospital. 
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 A Priscillal Devakirubai 
Designation  Associate Professor 
Affiliation  St Johns College of Nursing 
Address  St Johns College of Nursing St Johns National Academy of Health Sciences Sarjapur Road Bangalore - Karnataka
St Johns College of Nursing St Johns National Academy of Health Sciences Sarjapur Road Bangalore - Karnataka
Bangalore
KARNATAKA
560034
India 
Phone  8283841749  
Fax    
Email  apriscillalde@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A Priscillal Devakirubai 
Designation  Associate Professor 
Affiliation  St Johns College of Nursing 
Address  St Johns College of Nursing St Johns National Academy of Health Sciences Sarjapur Road Bangalore - Karnataka
St Johns College of Nursing St Johns National Academy of Health Sciences Sarjapur Road Bangalore - Karnataka
Bangalore
KARNATAKA
560034
India 
Phone  8283841749  
Fax    
Email  apriscillalde@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr A Priscillal Devakirubai 
Designation  Associate Professor 
Affiliation  St Johns College of Nursing 
Address  St Johns College of Nursing St Johns National Academy of Health Sciences Sarjapur Road Bangalore - Karnataka
St Johns College of Nursing St Johns National Academy of Health Sciences Sarjapur Road Bangalore - Karnataka
Bangalore
KARNATAKA
560034
India 
Phone  8283841749  
Fax    
Email  apriscillalde@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences, 4th T Block, Jayanagar, Bangalore, Karnataka. India PIN - 56004 
 
Primary Sponsor  
Name  Dr A Priscillal Devakirubai Self 
Address  St Johns College of Nursing St Johns National Academy of Health Sciences Sarjapur Road Bangalore Karnataka, India PIN-560034 
Type of Sponsor  Other [Self] 
 
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 
Dr A Priscillal Devakirubai  St Johns Medical College Hospital  OBG Department Sarjapur Road Bangalore Karnataka PIN 560034
Bangalore
KARNATAKA 		 8283841749

apriscillalde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Medical College Hospital, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primigravida women  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multi sensory stimulation vs standardised care   Music therapy - 3 mins Aromatherapy - 10 mins Tactile stimulation - whenever the mother perceives baby movement may be 18 - 20 times in a day Visual stimulation - 3-5 minutes 
Comparator Agent  Standardised care   All the antenatal, intranatal and postnatal standardised care will be provided - as per the hospital policy  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1 Primigravida women in 28-32 weeks period of gestation with singleton pregnancy
2 Spontaneous conception of multiple gestation  
 
ExclusionCriteria 
Details  1 Primigravida women who are in high risk category Preterm Labour Severe Preeclampsia Eclampsia Placenta Previa III and IV grade
2 Primigravida women who are diagnosed with psychiatric disorder by the psychiatrist
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Antepartum and Postpartum Maternal bonding  At baseline, 30 days after the intervention and after delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/03/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 The final study report will be published in one of the leading national journal  
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  apriscillalde@gmail.com

  6. For how long will this data be available start date provided 31-12-2025 and end date provided 31-12-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
 
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