Impact of Virtual Reality on Fear and Pain in Pediatric Patients

February 12, 2026 updated by: Merve Gümüş, Ege University

Impact of Virtual Reality on Fear and Pain in Pediatric Patients Undergoing Preoperative Preparation: A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR Group
Children in the intervention group watched a preoperative preparation video via a Virtual Reality (VR) headset
Other: virtual reality
Children in the VR group viewed the preoperative preparation video, after which fear levels were reassessed to determine the immediate effect of the intervention.
No Intervention: Control Group
Children in the control group received routine preoperative preparation according to the clinic protocol, without any additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Fear measured by the Children's Fear Scale (CFS)
Time Frame: Preoperative period (immediately before surgery)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain measured by the Wong-Baker FACES Pain Rating Scale (WBFPRS)
Time Frame: Postoperative 1st hour
The Wong-Baker FACES Pain Rating Scale is a validated pain assessment tool scored from 0 to 10. Higher scores indicate greater pain intensity.
Postoperative 1st hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Collaborators

Izmir Bakircay University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Can be shared upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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