NCT07131982

Brief Summary

It is important to prepare children and their mothers psychologically for surgery. There are many initiatives to achieve this psychological preparation, including interactive educational booklets for children and their families, hospital tours, educational multimedia applications, web-based preparation programs, virtual reality applications, virtual tours, therapeutic games, hospital clowning, and educational coloring books. Among these initiatives, the immersive features of virtual reality glasses are seen as an effective method for distracting children from negative stimuli. Informing children before surgery is effective in increasing their sense of control during medical and surgical interventions. The information provided before surgery effectively reduces pain and fear in children. This research aims to reduce the anxiety and fear of children undergoing surgery and their mothers, as well as to facilitate the child's recovery after surgery. Additionally, reducing the mother's anxiety and fear will enable her to provide higher-quality care to her child during the postoperative process. This study will be conducted using a prospective randomized controlled study design, matching children according to gender, age, and minor surgical reason, to determine the effect of animated videos shown through virtual reality glasses before surgery on perioperative anxiety and fear in children and their mothers. The objectives of the study are:

  • The animated video to be shown will reduce children's and mothers' fear of surgery.
  • The animated video to be shown will reduce children's and mothers' perioperative anxiety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 29, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

August 13, 2025

Last Update Submit

March 2, 2026

Conditions

Keywords

childrenanxietysurgeryfear

Outcome Measures

Primary Outcomes (1)

  • Multidimensional Perioperative Anxiety Scale for Children

    This scale was developed by Chow and colleagues to assess perioperative anxiety in children aged 7-13 years undergoing day surgery. As the score increases, anxiety increases. The scale is administered to children aged 7-13 years a total of three times: on the day the surgical procedure date is scheduled, on the day of the surgical procedure, and one month after the surgical procedure.

    one month

Secondary Outcomes (2)

  • Child Fear Scale

    one month

  • State-trait Anxiety Inventory

    one month

Study Arms (2)

intervention group

ACTIVE COMPARATOR

On the morning of the surgery, before the operation, children and their mothers who are included in the training group will be administered the following questionnaires: the Physiological Parameters Measurement Form, the Children's Fear Scale, and the Multidimensional Perioperative Anxiety Scale for Children (for children) and the State Anxiety Inventory-Short Form (for mothers). After the scales are administered, a pre-recorded video content, approximately 5 minutes in length and written by the researchers, will be shown to the child and mother on the morning of the surgery using a Virtual Reality Headset. Fifteen minutes after the video presentation, the Physiological Parameters Measurement Form, Multidimensional Perioperative Anxiety Scale for Children, and Children's Fear Scale will be administered to the children, and the State Anxiety Inventory-Short Form will be administered to the mothers. One hour post-op, the Physiological Parameters Measurement Form, Multidimensional Periop

Other: Informative Animated Video to be Viewed with Virtual Reality Glasses

control group

NO INTERVENTION

No interventions other than clinical routines will be performed on children in the control group, and they will be evaluated during the standard care process. Before surgery, the Physiological Parameters Measurement Form, Children's Fear Scale, and Multidimensional Perioperative Anxiety Scale questions will be administered to children, and the State Anxiety Inventory-Short Form questions will be administered to mothers. The scales will be administered again 15 minutes after administration and at the 1-hour post-operative mark.

Interventions

No study has been found in the literature evaluating the effect of animated videos shown to children through virtual reality glasses on mothers and children. The aim of this study was to determine the effect of animated videos shown through virtual reality glasses before surgery on perioperative anxiety and fear in children and their mothers.

intervention group

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 7-13,
  • Those who will undergo surgery for the first time,
  • Able to read and write,
  • Her mother and herself agreed to participate in the study,
  • No communication problems,
  • It will be done with children who can speak and understand Turkish and their mothers.

You may not qualify if:

  • With developmental disabilities,
  • Having a history of neurological disease or psychoactive drug use,
  • Those with hearing and/or visual impairments,
  • Children with a history of previous surgery and their mothers will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: intervention group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 20, 2025

Study Start

February 29, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations