FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/098625 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 06/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Smartphone based intervention]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparison between smartphone usage and medication like midazolam to assess which is better in reducing preoperative anxiety in paediatric patients  
Scientific Title of Study   A comparative evaluation of efficacy of smartphone based intervention v/s standard premedication using oral midazolam for preoperative anxiety in paediatric patients. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vasudha Govil 
Designation  associate professor 
Affiliation  Pt. B.D Sharma PGIMS Rohtak 
Address  Department of anaesthesia and critical care, second floor, new ot cum icu complex, PGIMS, rohtak

Rohtak
HARYANA
124001
India 
Phone  9466236862  
Fax    
Email  vasudha_govil@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Vasudha Govil 
Designation  associate professor (guide) 
Affiliation  Pt. B.D Sharma PGIMS Rohtak 
Address  Department of anaesthesia and critical care , second floor, new ot cum icu complex, PGIMS, rohtak

Rohtak
HARYANA
124001
India 
Phone  9466236862  
Fax    
Email  dakshmalik315@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vasudha Govil 
Designation  associate professor 
Affiliation  Pt. B.D Sharma PGIMS Rohtak 
Address  Department of anaesthesia and critical care, second floor, new ot cum icu complex, PGIMS , rohtak

Rohtak
HARYANA
124001
India 
Phone  9466236862  
Fax    
Email  vasudha_govil@yahoo.com  
 
Source of Monetary or Material Support  
Pt. B.D. Sharma, PGIMS, Rohtak, Haryana pin: 124001 
 
Primary Sponsor  
Name  Pt. B.D Sharma, PGIMS, Rohtak 
Address  Department of anaesthesiology and critical care, Pt. B.D Sharma, PGIMS, Rohtak 
Type of Sponsor  Government 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 
Dr Vasudha govil  Pt.B.D. sharma , PGIMS, Rohtak  Department of anaesthesia, 2nd floor, new ot cum icu complex , PGIMS, ROHTAK
Rohtak
HARYANA 		 9466236862

vasudha_govil@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee, PGIMS, ROHTAK   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F439||Reaction to severe stress, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral midazolam  To study anxiety using mYPAS-SF scale, quality of induction using icc score, peri operative hemp dynamic stability, parental anxiety using state trait anxiety inventory , by using oral midazolam 
Intervention  smartphone based intervention  To study anxiety using mYPAS-SF scale, quality of induction using icc score, peri operative hemp dynamic stability, parental anxiety using state trait anxiety inventory , by using smartphone based intervention Duration of intervention will be 30 mins in the preoperative room and 10 mins including transportation, till induction of the patient  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Children between age 2-6 years which fall under American society of Anaesthesiology(ASA) physical status 1 and 2 posted for elective surgery under general anaesthesia 
 
ExclusionCriteria 
Details  Patient/guardian who refuses to give consent, child with history of any psychiatric illness, child with ongoing psychiatric medications, child with known intellectual disability, child with known severe visual and hearing impairment, child with previous anaesthetic exposure, child requiring emergency surgery. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Anxiety using mYPAS-SF score  1. A day before surgery during pre anaesthesia checkup
2. After entry in the preoperative room
3. During leaving preoperative room to operating room(30mins after the intervention)
4. Just before induction  
 
Secondary Outcome  
Outcome  TimePoints 
Parental anxiety using STAI  Arrival in the preoperative holding room(P0), child leaving the preoperative room for operating room(P1)(that is 30mins after the intervention) 
Induction compliance using ICC (induction compliance checklist)score  During induction 
Hemodynamic parameters( heart rate, oxygen saturation, non invasive blood pressure)  Day before surgery during Pre anaesthetic checkup(H0), after arrival in the holding area(H1), just before induction(H2), 1min after induction(H3), 5min after induction(H4) 
 
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)   01/01/2026 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dakshmalik315@gmail.com].

  6. For how long will this data be available start date provided 01-10-2026 and end date provided 31-03-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This thesis aims to evaluate and compare the effectiveness of smartphone-based interventions versus oral midazolam in managing preoperative anxiety among pediatric patients undergoing elective surgery under general anesthesia. Preoperative anxiety affects up to 60% of children and is associated with difficult anesthetic induction, prolonged recovery, and negative postoperative behaviors. While oral midazolam remains a standard pharmacological premedication, it carries risks such as paradoxical reactions, respiratory depression, and delayed recovery. Non-pharmacological strategies, particularly digital tools like smartphone-based distraction and relaxation applications, have shown promising results internationally but remain underexplored in India.
The proposed study will be a prospective, randomized controlled trial conducted at Pt. B.D. Sharma PGIMS, Rohtak, involving 60 children aged 3–7 years (ASA I and II), divided equally into two groups: smartphone intervention and oral midazolam. Outcomes will be assessed using validated scales—the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF) for child anxiety, the Induction Compliance Checklist (ICC) for cooperation during induction, perioperative hemodynamic monitoring, and the State-Trait Anxiety Inventory (STAI) for parental anxiety.
The findings are expected to determine whether smartphone-based methods can provide a safe, effective, and economical alternative to sedative premedication, potentially transforming pediatric perioperative care in resource-limited settings.
 
Close