| CTRI Number |
CTRI/2025/07/091274 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [Integrated program] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Integrated Program upon Parental Competency and Clinical Outcomes of Children Undergoing Surgery. |
|
Scientific Title of Study
|
Effectiveness of Integrated Program upon Parental Competency and Clinical Outcomes of Children undergoing Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joselin Anna Bel P C |
| Designation |
Reader |
| Affiliation |
Apollo College of Nursing |
| Address |
Academic Block I
IV floor
Room No 37
Child Health Nursing Department
Apollo College of Nursing
Vanagaram to Ambattur Main road
Ayanambakkam
Chaennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
8903114001 |
| Fax |
|
| Email |
pcjoselin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nesa Sathya Satchi |
| Designation |
Principal |
| Affiliation |
Apollo College of Nursing |
| Address |
Academic Block I
Ground Floor
Room No 14
Apollo College of Nursing
Vanagaram to Ambattur Main road
Ayanambakkam
Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
8973977910 |
| Fax |
|
| Email |
drnesasathya_s@apollohospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Joselin Anna Bel PC |
| Designation |
Reader |
| Affiliation |
Apollo College of Nursing |
| Address |
Academic Block I
IV floor
Room No 37
Child Health Nursing Department
Apollo College of Nursing
Vanagaram to Ambattur Main road
Ayanambakkam
Chaennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
8903114001 |
| Fax |
|
| Email |
pcjoselin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Childrens Hospital
15 shafee mohammed road Thousand lights Chennai 600006
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Joselin Anna Bel P C |
| Address |
Apollo College of Nursing Vanagaram to Ambattur main road Ayanambakkam Chennai |
| Type of Sponsor |
Other [PhD Research Scholar 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 |
| Joselin Anna Bel PC |
Apollo Childrens Hospital |
Inpatient Block
II floor
Room No 2
Nursing office
15 Shafee Mohammed Road
Thousand light
Chennai 600006
Chennai
TAMIL NADU |
8903114001
pcjoselin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC of Apollo College of Nursing |
Approved |
| IEC of Apollo College of Nursing |
Approved |
| IEC of Apollo College of Nursing |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Integrated Program
Routine care 15 minutes |
It is a program to empower the parents and children on pre operative virtual operation theatre tour (VOT) and counselling the parents on post-operative care of children undergoing surgery which will be conducted during preoperative period for half an hour through various approaches lecture cum discussion using power point presentation video shows and demonstration of quality post operative care by parents of children undergoing surgery to improve their clinical outcomes. |
| Intervention |
Pre-operative Virtual OT Tour and Counselling 15 to 20 minutes |
It refers to the orientation of parents and the child undergoing surgery to the Operation
Theatre using video tapes. The video show is for about 7 minutes’ duration. It includes the Operation Theatre set-up as well as the health personnel who will take care of the child during and after surgery.
Counselling the parents on postoperative care of children for about 15-20 minutes. It includes general information about the ICU care monitoring discomforts like pain & anxiety, play therapy, recognize the warning signs and complications after surgery, Health education, discharge and follow up of children after surgery. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children who were admitted preoperatively for elective surgeries
willing to participate in the study
Available at the time of data collection |
|
| ExclusionCriteria |
| Details |
Children who are seriously ill
Posted for emergency surgery
Children who were physically or mentally challenged or with any developmental delay
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the integrated program upon Parental Competency and clinical outcome of children |
Day 1 Posttest 1 will be conducted to assess the pain
Day 4 of intervention posttest 2 will be conducted to assess the parental competency |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the relationship between the outcome variables & parental competency
Association between selected background variables of parents & parental competency
Association between selected demographic & clinical variables of children undergoing Surgery & their clinical outcomes |
2 week after intervention Post-test 3 will be conducted to assess the competency & clinical outcomes of children readmissions postoperative complications discharge & follow up of children after surgery |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
20/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response (Others) - NIL
- What additional supporting information will be shared?
Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 07-01-2025 and end date provided 07-12-2026?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
An Evaluative Study to Determine the Effectiveness of Integrated Program (VOT and Counselling) upon Parental Competency and Clinical Outcomes of Children undergoing Surgery at Selected Hospitals, Chennai. Primary Objectives 1 To evaluate the effectiveness of Integrated Program upon Parental Competency in Postoperative care of children 2 To evaluate the effectiveness of Integrated Program upon Clinical Outcomes of Children undergoing Surgery Secondary Objectives 3 To determine the level of acceptability regarding Integrated Program among the experimental group of parents with children undergoing surgery. 4 To determine the relationship between the outcome variables and parents’ knowledge and perceived parenting skills 5 To determine the association between selected background variables of parents and parental competency on post-operative care of children among the control and experimental group. 6 To determine the association between selected demographic and clinical variables of children undergoing Surgery and their clinical outcomes in the control and experimental group
Research Methodology Research Approach An evaluative approach will be used in this study Research Design Children C Control Group O1 C - O 2 C O3 C Experimental Group O1 C X O 2 C O3 C
Parent P Control Group O1 P - O3 P O4 P Experimental Group O1 P X O3 P O4 PChildren (C) O1 C - Pre-test to assess the anxiety of children in control and experimental group of children undergoing surgery. X – Integrated Program on pre-operative virtual operation theatre tour (VOT). O2 C - Post-test 1 will be conducted on POD 1 to assess the clinical outcomes of children (pain) O3 C – After 4 days of intervention post-test 2 will be conducted to assess the clinical outcomes (duration of hospital stay, parent and child satisfaction). Parents (P) O1 P - Pre-test to assess the knowledge of parents on Post-operative care in control and experimental group of children and parents of children undergoing surgery. X – Integrated Program on pre-operative virtual operation theatre tour (VOT) and Counselling on post-operative care of children undergoing surgery. Counselling the parents on postoperative care of children for about 15- 20 minutes. O3 P –After 4 days of intervention post-test 2 will be conducted to assess the competency on post-operative care of children. O4 P - After two week of intervention post-test 3 will be conducted to assess the competency and clinical outcomes of children (readmissions & post-operative complications, discharge and follow up of children after surgery).
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