Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07128056

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
Fatima Numeri · Other Government
Sex
All
Age
3 Years – 12 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALMobile phone video game distractionChildren 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.
OTHERStandard peri operative careStandard preoperative and postoperative care according to institutional protocol, without mobile phone video game distraction.

Timeline

Start date
2025-08-15
Primary completion
2026-04-15
Completion
2026-07-30
First posted
2025-08-17
Last updated
2025-08-21

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT07128056. Inclusion in this directory is not an endorsement.