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OpenTrials
Completed

NCT Number: NCT07415343

Impact of Virtual Reality on Fear and Pain in Pediatric Patients

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • Izmir Bakircay University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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