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

NCT07128056 | Not Yet Recruiting

• 2 other identifiers: PEDS-ANXPAIN-2025-01IRB/2024/1434/SIMS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Preoperative Anxiety; Postoperative Pain; Elective Surgical Procedure

Outcome Measures

Primary Outcomes (2)

• Preoperative Anxiety Level

  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.

  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.

• Postoperative Pain Intensity

  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.

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

Study Arms (2)

Mobile phone video game distraction

EXPERIMENTAL

Participants will play age-appropriate, non-violent mobile phone video games for approximately 20 minutes before induction of anesthesia as a distraction technique, in addition to receiving standard perioperative care

Behavioral: Mobile phone video game distraction; Other: Standard peri operative care

Standard perioperative care

ACTIVE COMPARATOR

Participants will receive standard perioperative care according to institutional protocols, without exposure to the mobile phone video game distraction

Other: Standard peri operative care

Interventions

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.

Mobile phone video game distraction

Standard peri operative care OTHER

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

Mobile phone video game distraction; Standard perioperative care

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatima Numeri: lead
• Services Institute of Medical Sciences, Pakistan: collaborator

Study Sites (1)

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

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

• Bezgin S, Kuyulu S, Atıcı A. Investigation of the effect of video-based game application on acute pain in children under surgery. Journal of Health Sciences and Medicine. 2025;8(1):115-118. doi:10.32322/jhsm.123456

  BACKGROUND

• Teruel J, Stafford G, Brown J, Jones B, Hopkins M, Johnson A, Edenfield J, Guo A, Schammel C, Renfro S, Nisonson A. Reduction of perioperative anxiety using a hand-held video game device: A randomized study. Perioperative Care and Operating Room Management. 2021 Dec;24:100203. doi:10.1016/j.pcorm.2021.100203.

  BACKGROUND

• Rostami E, Khanjari S, Haghani H, Amirian H. Effect of video games on preoperative anxiety in 3- to-6-year-old of a sample of Iranian children undergoing elective surgery. J Educ Health Promot. 2022 Apr 28;11:135. doi: 10.4103/jehp.jehp_455_21. eCollection 2022.

  PMID: 35677284 BACKGROUND

• Mustafa MS, Shafique MA, Zaidi SDEZ, Qamber A, Rangwala BS, Ahmed A, Zaidi SMF, Rangwala HS, Uddin MMN, Ali M, Siddiq MA, Haseeb A. Preoperative anxiety management in pediatric patients: a systemic review and meta-analysis of randomized controlled trials on the efficacy of distraction techniques. Front Pediatr. 2024 Feb 19;12:1353508. doi: 10.3389/fped.2024.1353508. eCollection 2024.

  PMID: 38440185 BACKGROUND

• Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.

  PMID: 16882820 BACKGROUND

• Ali MA, Khan MH, Salim B. Comparing Pharmacological and Nonpharmacological Interventions for Alleviating Preoperative Anxiety in Pediatric Surgical Patients: A Randomized Controlled Trial in Pakistan. Cureus. 2025 Apr 18;17(4):e82502. doi: 10.7759/cureus.82502. eCollection 2025 Apr.

  PMID: 40385813 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

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

  Services Institute of Medical Sciences, Pakistan

  STUDY DIRECTOR

Central Study Contacts

Dr Huma Imtiaz, MBBS

CONTACT

+92 305 3864695; humaimtiaz60@gmail.com

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

CONTACT

+92 321 4017065; Fatimanaumeri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors who score preoperative anxiety (m-YPAS-SF) and postoperative pain (Wong-Baker FACES) will be blinded to participants' group assignment. Clinical staff and participants cannot be blinded due to the nature of the intervention (mobile phone video games). Assessors will be instructed not to ask about the intervention, and data collection will use standardized forms. The statistician performing primary analyses will be blinded to group allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Paediatric surgery

Model Details: This is a two-arm, parallel-group trial in which pediatric patients undergoing elective surgery will be allocated in a 1:1 ratio to either the intervention arm, receiving mobile phone video game play in addition to standard perioperative care, or the control arm, receiving standard perioperative care alone. Both groups will be assessed for preoperative anxiety and postoperative pain using validated pediatric scales at specified time points.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 15, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)