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CTRI Number  CTRI/2024/06/068690 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   A comparison of severity of pain measured using smartphone version with traditional paper version of visual analogue pain scale in children 
Scientific Title of Study   A comparison between smartphone version with traditional paper version of visual analogue pain scale for pain assessment in children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anushree Mohan A 
Designation  Junior Resident  
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anesthesiology, Kasturba Medical College, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  8105689821  
Fax    
Email  anushreeadoor@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Malavika Kulkarni 
Designation  Additional Professor  
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anesthesiology, Kasturba Medical College, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9844241620  
Fax    
Email  malavika.muralidhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anushree Mohan A 
Designation  Junior Resident  
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anesthesiology, Kasturba Medical College, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  8105689821  
Fax    
Email  anushreeadoor@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College,Manipal Academy of Higher Education, Manipal, Udupi, Karnataka,India 576104 
 
Primary Sponsor  
Name  Anushree Mohan A 
Address  Junior Resident, Department of Anesthesiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 
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 
Dr Anushree Mohan A  Kasturba Medical College  Department of Anesthesiology, Main Operation Theatre Complex Manipal
Udupi
KARNATAKA 		 8105689821

anushreeadoor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional 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  NIL  NIL 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children of ASA 1-3 status undergoing surgery and a planned post surgical recovery in Postanaesthetic Care Unit (PACU) 
 
ExclusionCriteria 
Details  Children Unwilling to participate
Children with Neurological injury, psychomotor dysfunction
Children with significant visual or hearing impairment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of postoperative pain: The participant will self report the pain using both the paper VAS and the smartphone version at T0 and T1. The pain will be assessed at rest and with activity. If the participant reports pain score
≥40 at rest, pain assessment on activity will not be conducted. 		 The first(T0) set of pain assessment will take place in the PACU when the participant is fully awake as deemed appropriate for assessment by the bedside nurse.

The second (T1) set of pain assessment will be performed when the participant is fit for discharge from the PACU 
 
Secondary Outcome  
Outcome  TimePoints 
The child’s preference for the smart phone version or the hardcopy version of the tool.  The preference will be assessed when the child is fit to be discharged from Postoperative Care Unit (T1) 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
Final Enrollment numbers achieved (Total)= "125"
Final Enrollment numbers achieved (India)="125" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/06/2024 
Date of Study Completion (India) 09/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 is an unpleasant sensory & emotional experience associated with actual or potential tissue damage” with multiple dimensions.
Poorly controlled post-operative pain has a number of negative consequences for the patient such as delay in functional recovery, hospital discharge and increased risk of chronic pain.
The visual analogue pain scale is a well recognized & validated self- report scale in children & adults and its use has been validated in children above 7 years.
The electronic pain assessment tools have the potential to promote compliance, co-operation, consistency in results & promote better communication between healthcare professionals, pediatric patients and their care givers.
Primary aim of the study is to compare the smartphone version of visual analogue pain scale with the traditional paper version in the assessment of pain in children and the secondary objective is to determine the child preference for the smart phone version or the hardcopy version of the tool
 
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