| CTRI Number |
CTRI/2026/03/105295 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Impact of Nurse-Facilitated Distraction Strategies] |
| Study Design |
Other |
|
Public Title of Study
|
Nurse-Facilitated Distraction Strategies on Post-Operative Pain, Anxiety and Maternal Satisfaction After Childrens Surgery |
|
Scientific Title of Study
|
Impact of Nurse-Facilitated Distraction Strategies on Post-Operative Pain, Anxiety and Maternal Satisfaction among Children: A hospital based study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay L Alagundi |
| Designation |
Senior Tutor |
| Affiliation |
DR. Prabhakar Kore Hospital and MRC Nehru Nagar Belagavi |
| Address |
Ground floor pediatric surgery ward DR. Prabhakar Kore Hospital and MRC Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7259999150 |
| Fax |
|
| Email |
sanjay.alagundi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gavisidayya Salimath |
| Designation |
Professor and HOD |
| Affiliation |
KAHER Institute of Nursing Sciences Belagavi |
| Address |
KAHER Institute of Nursing Sciences Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9480033476 |
| Fax |
|
| Email |
gavisalimath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay L Alagundi |
| Designation |
Senior Tutor |
| Affiliation |
KAHER Institute of Nursing Sciences Belagavi |
| Address |
KAHER Institute of Nursing Sciences Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7259999150 |
| Fax |
|
| Email |
sanjay.alagundi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
Nehru Nagar, Belagavi, Karnataka 590010 |
| 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 |
| Mr Sanjay l alagundi |
KLES Dr. Prabhakar Kore Hospital and MRC |
Ground floor pediatric surgery ward DR. Prabhakar Kore Hospital and MRC Nehru Nagar Belagavi
Belgaum
KARNATAKA |
7259999150
sanjay.alagundi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethical Committe (Human) for Ph.D. Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q439||Congenital malformation of intestine, unspecified, (2) ICD-10 Condition: Q54||Hypospadias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-Facilitated Distraction Strategies |
Nurse-Facilitated Distraction Strategies (NFDS): It refers to the distraction technique that
directs attention away from Post operative pain in children, this is planned according to the
age of the child and these techniques include: Visual, auditory, Tactile and Cognitive
distraction Techniques.
On the day of admission the anxiety of the child is assessed by the researcher using mYPAS Scale.
On postoperative day 1 the pain and physiological parameters will be assessed after 4 hours of surgery. Next pain and physiological parameters will be assessed every fourth hourly
After 6 hours of surgery the child receives an age appropriate distraction intervention for sixty minutes.
Each day a new distraction activity is provided for the child.
To avoid cross-infection all the toys will be cleaned with the help of Dettol solution and the contaminated toys will be replaced with a new kit.
After completion of distraction activity, the child is asked to relax and the pain and physiological parameters will be reassessed after 15 minutes.
On postoperative day two and three the pain and physiological parameter will be assessed every seventh hourly and distraction activity is given twice a day.
During all the three days the child will also receive standard care in the postoperative unit.
On the day of admission the anxiety of the child is assessed by the researcher using mYPAS Scale.
On postoperative day 1 the pain and physiological parameters will be assessed after 4 hours of surgery. Next pain and physiological parameters will be assessed every fourth hourly
After 6 hours of surgery the child receives an age appropriate distraction intervention for sixty minutes.
Each day a new distraction activity is provided for the child.
To avoid cross-infection all the toys will be cleaned with the help of Dettol solution and the contaminated toys will be replaced with a new kit.
After completion of distraction activity, the child is asked to relax and the pain and physiological parameters will be reassessed after 15 minutes.
On postoperative day two and three the pain and physiological parameter will be assessed every seventh hourly and distraction activity is given twice a day.
During all the three days the child will also receive standard care in the postoperative unit.
|
| Comparator Agent |
Routine care |
All assessments are done same as the intervention group but the child receives no any distraction activity and the child will receive standard care in the postoperative unit
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children admitted for surgery and available for three postoperative days
In the age group of 7 to 14 years
Children undergone abdominal and urogenital surgeries and emergency surgeries |
|
| ExclusionCriteria |
| Details |
Undergoing cardiac and head and neck and orthopedic surgeries
Mentally challenged and physically disable
Diagnosed for neurological or behavioral disorders will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of nurse-facilitated distraction strategies in reducing postoperative pain & anxiety among pediatric patients. |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the level of post-operative pain & anxiety among children undergoing surgery in a
quaternary care hospital.
|
3 days |
To compare post-operative pain & anxiety levels among children between intervention and
control group.
|
3 days |
To assess maternal satisfaction regarding the use of nurse-facilitated distraction Strategies in
post-operative pain management. |
3 days |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/04/2026 |
| 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="3"
Months="0"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sanjay.alagundi@gmail.com].
- For how long will this data be available start date provided 01-07-2027 and end date provided 01-01-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
sample recruiting will be conducted once tool is validated |