| CTRI Number |
CTRI/2025/08/092675 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [educational] |
| Study Design |
Other |
|
Public Title of Study
|
Client centric teaching program |
|
Scientific Title of Study
|
Effectiveness of client centric teaching program on bonding, anxiety, knowledge and practice towards the care of preterms among mothers of a selected tertiary care hospital. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHARIN NEETAL DSOUZA |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya nursing college |
| Address |
Department of child health nursingYENEPOYA NURSING COLLEGE
yenepoya nursing college
Mangalore
nil
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09972413432 |
| Fax |
|
| Email |
dsouzasharin83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHARIN NEETAL DSOUZA |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya nursing college |
| Address |
Departemt of Child health nursing YENEPOYA NURSING COLLEGE
Yenepoya university
mangalore
nil
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09972413432 |
| Fax |
|
| Email |
dsouzasharin83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHARIN NEETAL DSOUZA |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya nursing college |
| Address |
Department of child health nursing YENEPOYA NURSING COLLEGE
Yenepoya university
Manglore
nil
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09972413432 |
| Fax |
|
| Email |
dsouzasharin83@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Yenepoya Nursing college |
| Address |
Yenepoya nursing college, Yenepoya university
kallarakodi, Bantwal Taluk, Naringana, DK dist,
Mangalore |
| 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 |
| Dr Noothan |
Yenepoya medical college hospital |
Yenepoya university
Deralakatte Mangalore
Dakshina Kannada
KARNATAKA |
09972413432
123noothan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
admitted mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cient centric education program |
a. Video assisted teaching on care of preterm neonate including Kangaroo mother care, expression of breast milk, prevention of infection, care of skin. This teaching is done for 15minutes.
b. Demonstration of various aspects of care of preterm neonate including routine care of neonates which include hand washing, wearing gloves, wearing gown to enter NICU, holding the baby, care of eyes, cord care, breast feeding technique, burping, mummification. The demonstration session will be for 20minutes, after the demonstration investigator will insure that mother does the return demonstration and gains the skill.
c. Interactive session this will be given after video teaching and demonstration to the mothers. Here mother will be encouraged to ask questions or any doubts regarding care of preterm babies and investigator will be clarifying the doubts. This teaching is done for 10minutes.
d. Training will be provided to mother once a day for 3 days.
|
| Intervention |
Client centric education program |
a. Video assisted teaching on care of preterm neonate including Kangaroo mother care, expression of breast milk, prevention of infection, care of skin. This teaching is done for 15minutes. b. Demonstration of various aspects of care of preterm neonate including routine care of neonates which include hand washing, wearing gloves, wearing gown to enter NICU, holding the baby, care of eyes, cord care, breast feeding technique, burping, mummification. The demonstration session will be for 20minutes, after the demonstration investigator will insure that mother does the return demonstration and gains the skill. c. Interactive session this will be given after video teaching and demonstration to the mothers. Here mother will be encouraged to ask questions or any doubts regarding care of preterm babies and investigator will be clarifying the doubts. This teaching is done for 10minutes. d. Training will be provided to mother once a day for 3 days |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Mother who is,
1. Admitted in postnatal ward
2.Permitted to visit NICU regularly and involve in care of preterm neonates.
|
|
| ExclusionCriteria |
| Details |
Mothers who are,
1. Having postnatal complications which hinders her to participate in CCTP
2. Physically and mentally not stable / challenged
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| getting education about newborn care |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| early discharge of newborn |
2-3weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="10" |
|
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
|
Newborns are vulnerable group who need more attention and care. If it is preterm babies, more care and protection are needed. The transition end when the parent develops a sense of comfort and confidence in performing the parental role. The parenting process requires cognitive and affective skills, knowledge and motor skills. It requires attachment, bonding, proximity, reciprocity and commitment. During hospitalization of their baby, mothers may experience several and often contradictory emotional reactions, such as grief, sadness, guilt, fear, anger, loss of self-esteem and sense of failure. In fact, this situation can be so overwhelming for mothers that they might react by emotionally distancing themselves from their children. This study aims to provide client centric education program to the mothers so that they can update their knowledge, clarify their doubts, enhance their skills in the care along with this they will be provided to demonstrate certain important procedures which is needed in routine care of their preterm neonate. This study will be done in selected medical college hospitals of Mangaluru. Total 80 samples will be selected based on the selection criteria. Selected samples will be divided into intervention and control groups. Intervention group will be receiving client centric education and control will be receiving the routine care. These samples will be selected by using non probability purposive sampling technique. The collected data will be analyzed by descriptive and inferential statistics. |