| CTRI Number |
CTRI/2025/02/080375 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Parent bookreading] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of book-reading on stress in fathers of hospitalized neonates |
|
Scientific Title of Study
|
Effectiveness of parent-infant book reading on parental stress in fathers with hospitalized neonates. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raji Ramanujan |
| Designation |
Masters Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Bangalore, Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9900855771 |
| Fax |
|
| Email |
raji.mhsblr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeeshma Vijin |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of higher Education, Bangalore,
Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
08217723829 |
| Fax |
|
| Email |
jeeshma.vijin@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jeeshma Vijin |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, Manipal Academy of higher Education, Bangalore,
Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
08217723829 |
| Fax |
|
| Email |
jeeshma.vijin@manipal.edu |
|
|
Source of Monetary or Material Support
|
| No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal
College of Health Professions,Manipal Academy of Higher Education, Bangalore 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
No.98, Rustam Bagh Road, Old Airport Road, Department of Clinical Psychology, Manipal
College of Health Professions,Manipal Academy of Higher Education, Bangalore 560017 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Raji Ramanujan |
Manipal Hospitals, Bangalore |
Department of Neonatology, Inpatient
Service, 9th floor, Manipal
Hospital #98,HAL Old
Airport Road,Bangalore
Bangalore
560017
Bangalore
KARNATAKA |
9900855771
raji.mhsblr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fathers of hospitalized neonates |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Parent-infant book reading |
Participants will read storybooks to their neonate in infant-directed speech for 20-30 minutes.
Three reading sessions will be administered across one week. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Fathers with neonatal hospitalization of at least 1 week |
|
| ExclusionCriteria |
| Details |
- Fathers whose neonates have been hospitalized for less than 1 week.
- Fathers whose infants are in critical, unstable condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Parental Stress Scale- NICU |
1. At baseline (0 days)
2. At the end of intervention (7 days) |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2025 |
| Date of Study Completion (India) |
01/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Parent-infant book reading has been studied in detail regarding its benefits to NICU infants. It fosters language exposure and cognitive and emotional development in a population particularly vulnerable to neurodevelopmental disorders.
Thus far, research has studied parental stress only as a predictor variable for future parent reading behaviors. While much of the empirical evidence suggests that parents of NICU infants experience stress as well, most research concludes that the further direction of research must focus on providing caregiving opportunities to reduce parental stress due to parental role alteration.
Since shared reading has established benefits to the infant, it helps the parents feel they are contributing and participating in caring for their infant, thus providing an opportunity for the father to perform their parental role by engaging in caregiving activities. This study aims to determine if parental stress levels are reduced before and after parent-infant book reading. |