| CTRI Number |
CTRI/2025/11/097629 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of using a stress ball to reduce pain and anxiety in children during blood tests |
|
Scientific Title of Study
|
A study to assess the effectiveness of stress ball distraction technique on pain and anxiety among children undergoing phlebotomy at selected tertiary care hospital mangalore |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIVYA P |
| Designation |
PG Student |
| Affiliation |
YENEPOYA DEEMED UNIVERSITY |
| Address |
Department of Child Health Nursing
PG student
Yenepoya Deemed University
Yenepoya Nursing College Mangalore 575018
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7338527762 |
| Fax |
|
| Email |
divyayen64@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
SHARIN NEETAL D’SOUZA |
| Designation |
Associate Professor stage I |
| Affiliation |
YENEPOYA DEEMED UNIVERSITY |
| Address |
Department of Child Health Nursing
Associate Professor
Yenepoya Deemed university
Yenepoya nursing College
Mangalore 575018
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9972413432 |
| Fax |
|
| Email |
sharinneetal@yenepoya.edu.in |
|
Details of Contact Person Public Query
|
| Name |
DIVYA P |
| Designation |
PG STUDENT |
| Affiliation |
YENEPOYA DEEMED UNIVERSITY |
| Address |
Department of Child Health Nursing
PG student
Yenepoya Deemed University
Yenepoya Nursing College
Mangalore 575018
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7338527762 |
| Fax |
|
| Email |
divyayen64@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DIVYA P |
| Address |
Yenepoya Deemed University
Yenepoya Nursing College
Mangalore Karnataka 575018 |
| Type of Sponsor |
Private medical college |
|
|
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 SHARIN |
Yenepoya Medical College Hospital |
Department of Paediatrics
Yenepoya Medical College Hospital Deralakatte Mangalore 575018 Dakshina Kannada KARNATAKA |
9972413432
sharinneetal@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YENEPOYA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Distraction Technique |
Children in the intervention group will receive distraction during the phlebotomy procedure. Age-appropriate distraction techniques such as watching animated videos, blowing bubbles, or using toys/mobile games will be used to divert the child’s attention. The technique will be applied a few minutes before and continued during the blood collection procedure, lasting approximately 5–10 minutes |
| Comparator Agent |
Standard Care |
Children in the control group will undergo routine phlebotomy following standard hospital procedure without any distraction method. Usual comforting and safety measures will be maintained by the staff. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Child both male and female
In the age group of 11to17years
Admitted to paediatric units and undergoing phlebotomy sampling
Undergoing first phlebotomy
|
|
| ExclusionCriteria |
| Details |
Children with/on
Children with/on neurological disorders or cognitive impairments.
Children with/on chronic illnesses requiring frequent blood sampling.
Children with/on sedatives or analgesics before phlebotomy.
Children with/on emergency admission
Children with/on critical condition.
Children With / on Neuromuscular disorders and fractures of upper limb
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain score during phlebotomy
|
Immediately after needle insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physiological and behavioral responses of children during phlebotomy |
Before, during, and immediately after the phlebotomy procedure |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
25/11/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pain and anxiety are common concerns among children undergoing
medical procedures, particularly phlebotomy, which involves the insertion of a
needle for blood collection. This procedure can cause significant emotional
distress and physiological discomfort, often leading to crying, resistance, and
fear. Repeated exposure to painful medical experiences may result in needle
phobia, avoidance behaviours, and heightened anxiety in future healthcare
interactions. Therefore, implementing effective non-pharmacological
interventions is essential to alleviate distress and improve the overall
experience of paediatric patients. A quasi-experimental pre-test post-test control group design will
be adopted for this study. A non-probability purposive sampling technique will
be employed to select 60 children who belong to the age group of 11-17 years The
study will utilize structured data collection tools, including a demographic
proforma, Wong-Baker Faces Pain Scale, and Novel visual facial anxiety scale,
to assess the pain and anxiety levels. Data will be analysed using descriptive
and inferential statistics. Findings from this study are expected to provide
evidence-based recommendations for integrating distraction techniques into
routine paediatric care, improving the overall healthcare experience for
children. |