Impact of Virtual Reality on Fear and Pain in Pediatric Patients

NCT07415343 | Completed

• 1 other identifier: 872
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative fear and postoperative pain are common problems in children undergoing surgery and may adversely affect perioperative outcomes. Nonpharmacological, child-centered interventions that support emotional preparation are increasingly emphasized in pediatric nursing care. :To investigate the effects of virtual reality on preoperative fear and postoperative pain in children aged 5-12 years undergoing surgery.This randomized controlled study was conducted in accordance with the CONSORT guidelines. A total of 74 children were randomly assigned using block randomization to either the Educational Animation (VR) group (n = 36) or the control group (n = 38). Data were collected using an information form, the Children's Fear Scale, and the Wong-Baker Faces Pain Rating Scale. Preoperative fear was assessed by child, nurse, and researcher ratings, while postoperative pain was evaluated at two time points by parents, nurses, and the researcher. No significant differences were found between the VR and control groups in preoperative fear scores based on child, nurse, or researcher assessments (p \> .05). However, within the VR group, preoperative fear scores significantly decreased after the intervention across all evaluators (p \< .001). Postoperative pain scores were significantly lower in the VR group compared with the control group at both postoperative assessments according to parent, nurse, and researcher ratings (p \< .05 for all). VR-based educational interventions appear to be an effective and feasible, nurse-led nonpharmacological approach for reducing preoperative fear and postoperative pain in pediatric surgical patients. Integrating VR into routine preoperative nursing care may enhance children's perioperative experiences and support child-centered care practices.

Conditions

Pediatric Surgical Patients

Keywords

pediatrics; nursing; fear; pain; preoperative preparation; virtual reality

Outcome Measures

Primary Outcomes (1)

• Preoperative Fear measured by the Children's Fear Scale (CFS)

  The Children's Fear Scale is a validated self-report tool consisting of five facial expressions representing increasing levels of fear. Scores range from 0 to 4, with higher scores indicating greater fear.

  Preoperative period (immediately before surgery)

Secondary Outcomes (1)

• Postoperative Pain measured by the Wong-Baker FACES Pain Rating Scale (WBFPRS)

  Postoperative 1st hour

Study Arms (2)

VR Group

EXPERIMENTAL

Children in the intervention group watched a preoperative preparation video via a Virtual Reality (VR) headset

Other: virtual reality

Control Group

NO INTERVENTION

Children in the control group received routine preoperative preparation according to the clinic protocol, without any additional intervention.

Interventions

virtual reality OTHER

Children in the VR group viewed the preoperative preparation video, after which fear levels were reassessed to determine the immediate effect of the intervention.

VR Group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child and parent provided informed consent,
• the child was aged 5-12 years,
• scheduled to undergo surgery for the first time

You may not qualify if:

• they had any chronic medical illness,
• exhibited cognitive impairment or mental retardation,
• had previously undergone any surgical intervention,
• were scheduled for a complex surgical procedure

Sponsors & Collaborators

• Ege University: lead
• Izmir Bakircay University: collaborator

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 17, 2026
• Study Start: February 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

TU (1)