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NCT Number: NCT07128056

Effect of Mobile Phone Video Games on Preoperative Anxiety and Postoperative Pain in Children

This randomized controlled trial will evaluate the effect of mobile phone video game distraction on preoperative anxiety and postoperative pain in pediatric surgical patients. Children aged 3-12 years undergoing elective surgery under general anesthesia will be randomly assigned to either a video game distraction group or a control group receiving standard perioperative care. The primary outcomes are preoperative anxiety levels and postoperative pain scores. The study aims to determine whether a simple, low-cost behavioral intervention can improve perioperative experiences in children

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Surgery ,Services Institute of Medical Sciences/Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location contact

Dr Huma Imtiaz Postgraduate Resident,Pediatric surgery department,SIMS, MBBS

CONTACT

[email protected]

+92 305 3864695

Dr Huma Imtiaz Postgraduate Resident,Pediatric surgery department,SIMS, MBBS

SUB_INVESTIGATOR

Prof Dr Fatima Naumeri Professor of Pediatric Surgery, FCPS,MCPS-HPE,MCPS,CME

CONTACT

[email protected]

+92 321 4017065

Prof Dr Fatima Naumeri Professor of Pediatric surgery, FCPS,MCPS-HPE,MCPS,CME

PRINCIPAL_INVESTIGATOR

About this study

Preoperative anxiety and postoperative pain are common problems among pediatric patients undergoing surgery. Children often experience high levels of anxiety before a surgical procedure, and this preoperative anxiety can have long-term negative outcomes. Surgical tissue damage leads to moderate to severe postoperative pain, and preoperative anxiety is a significant predictor of postoperative pain. Inadequate pain management can result in delayed recovery, diminished quality of life, increased healthcare costs, and higher healthcare utilization.

Both pharmacological and non-pharmacological methods are used to manage preoperative anxiety and postoperative pain. However, pharmacological medications may have undesirable side effects, and non-pharmacological interventions such as music therapy, clown presence, or parental presence may not be feasible in the operating theatre environment.

Video games (VGs) are increasingly used in healthcare as distraction tools and for behavior modification therapy. Mobile phones are widely available, and playing video games has become a common activity in society. Children can become deeply engaged in playing VGs, which may reduce their awareness of the surgical environment and lower their anxiety levels. Reduced preoperative anxiety may, in turn, lead to decreased postoperative pain.

There is a lack of local research on the use of mobile phone video games in pediatric perioperative care. This study aims to evaluate the effect of mobile phone video games in reducing preoperative anxiety and postoperative pain, and to determine whether this intervention can be recommended for pediatric surgeries.

A randomized controlled trial will be conducted in the Department of Pediatric Surgery, Services Hospital Lahore, over 12 months. Children aged 3-12 years undergoing low-risk elective surgery will be enrolled. Informed consent will be obtained from parents or guardians. Participants will be randomized via the lottery method into:

  • Experimental group: Mobile phone video game distraction (n=75)
  • Control group: Standard perioperative care (n=75)

Anxiety will be measured at two points:

  • T1: In the preoperative waiting room
  • T2: After playing video games for 20 minutes, before induction of anesthesia in the operating room

The Modified Yale Preoperative Anxiety Scale - Short Form (m-YPAS-SF) will be used, where scores range from 22.92 to 100, with lower scores indicating lower anxiety. Postoperative pain will be assessed in the ward using the Revised Faces Pain Scale (r-FACES).

Data will be analyzed using SPSS v25. Numerical variables will be summarized as mean ± standard deviation, and categorical variables as frequencies and percentages. Independent sample t-tests will be used for numerical variables, and Chi-square tests for categorical variables. Data will be stratified for age, gender, and weight to control for effect modifiers. A p-value ≤ 0.05 will be considered statistically significant.

Preoperative anxiety management is a relatively neglected area in Pakistan, and international recommendations are not always applicable in resource-limited settings. The findings from this single-center clinical trial will provide evidence for local clinical practice and may serve as a framework for developing regional protocols to prevent adverse postoperative outcomes.

Limitations: Single-center design and the need for additional staff and time to conduct the study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 3-12y
  • Children undergoing elective surgery
  • Has access to a Mobile phone
  • Is able to speak in urdu
  • Children with no contraindications for the use of video games

Exclusion criteria

  • Children with previous surgical experience
  • Children with cognitive and learning disabilities
  • Children with a chronic illness/pain that required special medical care
  • Not familiar with video games

Treatment and study plan

Mobile phone video game distraction

Behavioral

Children in the intervention group will play age-appropriate, non-violent mobile phone video games for approximately 20 minutes before induction of anesthesia. This is intended as a distraction technique to reduce preoperative anxiety and improve postoperative pain outcomes. Participants will also receive standard perioperative care.

Standard peri operative care

Other

Standard preoperative and postoperative care according to institutional protocol, without mobile phone video game distraction.

Primary outcomes

  1. Preoperative Anxiety Level

    Time frame: Measured twice - (T1) in the preoperative waiting area before intervention, and (T2) after 20 minutes of mobile phone video game distraction, immediately before induction of anesthesia.

    Anxiety will be measured at two time points (T1 and T2). At T1, baseline anxiety will be assessed in the preoperative waiting room. Children randomized to the intervention group will then play mobile phone video games for 20 minutes, while the control group will not. At T2, anxiety will be reassessed immediately before induction of anesthesia in the operating room. Anxiety will be measured using the modified Yale Preoperative Anxiety Scale - Short Form (m-YPAS-SF), where scores range from 22.92 to 100, with lower scores indicating lower anxiety.

  2. Postoperative Pain Intensity

    Time frame: It will be measured at 1 and 12 hours after surgery in the ward.

    Post operative pain management will be standardized and it will be measured at 1 and 12 hours after surgery using revised faces pain scale (FPS-r) in the ward.It consists of six faces showing progressively increasing levels of distress with each face assigned a numerical value 0-10.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Huma Imtiaz, MBBS

CONTACT

[email protected]

+92 305 3864695

Prof Dr Fatima Naumeri, FCPS,MCPS-HPE,MCPS,CME

CONTACT

[email protected]

+92 321 4017065

Sponsors and collaborators

Lead sponsor

Fatima Numeri

Other Gov

Collaborators

  • Services Institute of Medical Sciences, Pakistan

Registry information

Official study title

Effect of Mobile Phone Video Games on Preoperative Anxiety and Postoperative Pain in Children Undergoing Elective Surgery

Acronym: VAPiC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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