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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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