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CTRI Number  CTRI/2025/10/095993 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 11/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [nursing care]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Atraumatic Approach Over Conventional Approach On Pediatric Patients  
Scientific Title of Study   Effectiveness Of Atraumatic Approach Over Conventional Approach On Pediatric Patients Pain, Anxiety And Parent Satisfaction During Cannulation Procedure At Tertiary Care Hospital Of Belagavi. A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak k 
Designation  PhD Scholar 
Affiliation  KLE academic of higher education Neharu Nagar  
Address  KLE academic of higher education Neharu Nagar Belagavi
Belgaum Institute Of Medical Science Belgaum. Ambedkar Road Neharu Nagar Belagavi.
Belgaum
KARNATAKA
590010
India 
Phone  9481858576  
Fax    
Email  deepak.bhat.kadatoka@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gavishidayya B Salimath 
Designation  Professor HOD 
Affiliation  KLE academic of higher education Neharu Nagar  
Address  KLE Institute Of Nursing Science Belagavi
KLE Institute Of Nursing Science Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  9480033476  
Fax    
Email  gavisalimath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deepak k 
Designation  PhD Scholar 
Affiliation  KLE academic of higher education Neharu Nagar  
Address  KLE academic of higher education Neharu Nagar Belagavi
Belgaum Institute Of Medical Science Belgaum. Ambedkar Road Neharu Nagar Belagavi.
Belgaum
KARNATAKA
590010
India 
Phone  9481858576  
Fax    
Email  deepak.bhat.kadatoka@gmail.com  
 
Source of Monetary or Material Support  
self funding 
 
Primary Sponsor  
Name  Deepak K 
Address  Kle academic higer education and research, Neharu Nagar Belagavi Karnatka 
Type of Sponsor  Other [self] 
 
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 
DEEPAK K  Belgaum Institute of Medical Science   Paeditric Ward Paediatric Department nehrunagar 590001
Belgaum
KARNATAKA 		 09481858676

deepak.bhat.kadatoka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER ethical committee human research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  As a convention approach in the control group  As a convention approach in the control group, standard care approach will be used where parent will be allowed with the child during the entire procedure, as in the intervention groups, and the investigator will start to communicate with the child for distraction (asking about their hobbies, favorite cartoon characters, games they liked to play with their friends) for 5 minutes. 
Intervention  the Atraumatic approach experimental group  In the Atraumatic approach experimental group, the children aged 6 to 12 years. This group will be given virtual reality (VR) experience. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children between 6 - 12 years admitted in paediatric ward of selected hospital.
Children who is able to speak Kannada and English language
Children who require successful intravenous cannulation care for the purpose of venous blood sampling or intravenous therapy based on prescription.
Children admitted to the paediatric ward with any one of the parents.
 
 
ExclusionCriteria 
Details  Parent those who are not willing to participate and to give assent.
Children who are having audio ,visual or speech impairment
Children who are having chronic pain, chronic illness, developmental delay and mental disability.
Children who are haemodynamically unstable.
Children for whom intravenous cannulation is done as emergency procedure
Children under the effect of analgesic and sedative drugs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
reducing the emotional and physical impact of medical interventions through non-pharmacologic approaches.   the virtual reality(VR) is a non-pharmacologic technique of atraumatic approach and an enjoyable activity that helps to distract children and decrease levels of pain and anxiety during cannulation.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   10/11/2025 
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="4"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  NIL

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 05-08-2025 and end date provided 05-01-2031?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Continuation of the Literature review.

Development of tool and their validation. sociodemographic data  and  questionnaire to assess satisfaction of the patient  has been developed and sent for the validation by the expert. and standardised tool such as wong bakers face scale and the Children’s Fear Scale (CFS) will be used. and permission obtain from the developer through email.

Plan and execution of pilot study. miniture study will be conducted KLE Dr. Prabhakar Kore charitable Hospital belgaum.

Constant discussion with expert in conducting research.

 
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