| CTRI Number |
CTRI/2025/06/089653 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of distraction cards on pain and anxiety in children during painful procedures |
|
Scientific Title of Study
|
Effectiveness of distraction cards on pain and anxiety in children during painful procedures in a hospital, Mangaluru |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRAJWAL K |
| Designation |
Post Graduate Student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Child Health Nursing, 3rd floor, Room Number 3
Father Muller College of Nursing,Kankanady Mangaluru
Dakshina Kannada
KARNATAKA
57002
India |
| Phone |
8762140844 |
| Fax |
|
| Email |
prajwal0844@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Helen Claret Dsouza |
| Designation |
Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Child Health Nursing, Floor number 3, Room number 3
Father Muller College of Nursing Kankanady Mangaluru
Dakshina Kannada
KARNATAKA
57002
India |
| Phone |
9591476770 |
| Fax |
|
| Email |
claretdsouza27@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
PRAJWAL K |
| Designation |
Post Graduate Student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Child Health Nursing, Floor number 3, Room Number 3
Father Muller College of Nursing Kankanady Mangaluru
Dakshina Kannada
KARNATAKA
57002
India |
| Phone |
08762140844 |
| Fax |
|
| Email |
prajwal0844@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prajwal k |
| Address |
Father Muller College of Nursing
kankanady, Mangaluru, Karnataka,India 575002 |
| Type of Sponsor |
Other [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 |
| Mrs Helen Claret DSouza |
Father Muller College Hospital Kankanady |
Father Muller Medical College Hospital, Procedure rooms of Pediatric Wards-K ward and OPDs, Floor Number 2, Kankanady, Mangaluru, Karnataka, India, 575002
Dakshina Kannada
KARNATAKA |
9591476770
claretdsouza27@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father muller institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of distraction cards. |
Children of the age group 6-10 years will be administered a group of 5 distraction cards once for a duration of 5 minuets |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
admitted to pediatric wards who are referred for painful procedure in the age group of
6-10 years.
|
|
| ExclusionCriteria |
| Details |
In this study the exclusion criteria will be the children:
-chronic pain condition.
-cognitive disabilities.
-visual impairments
-semi-conscious and unconscious child.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the effectiveness of distraction cards on pain and anxiety in children during painful procedure |
9 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Children often recall the experience more positively when distraction is used, which can reduce future procedural distress. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
The study on the effectiveness of distraction cards in reducing pain and anxiety among children during painful procedures is important as it highlights a simple, non-pharmacological method to support child-centered care. Painful medical procedures can be distressing for children, often leading to fear, anxiety, and lack of cooperation. This study emphasizes how distraction cards, by engaging a child’s attention, can significantly lower pain perception and anxiety levels. Their use not only improves the emotional well-being of the child but also enhances the efficiency of healthcare delivery by promoting better cooperation during procedures. Moreover, distraction cards are cost-effective, easy to implement, and require minimal training, making them a practical tool for everyday clinical use. |