Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT07128056
Brief 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
Study:
NCT07128056
Study Brief:
Protocol Section:
NCT07128056