THE EFFECT OF VIRTUAL REALITY ON CHILDREN'S ANXIETY, FEAR, AND PAIN LEVELS BEFORE CIRCUMCISION IN TURKEY

NCT04778683 | Completed

• 1 other identifier: OMU-B.30.2.ODM.0.2
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Circumcision is one of the most common surgical interventions in boys, and boys undergoing this procedure experience anxiety and fear during the preoperative period. In addition, postoperative pain in children is reported to be associated with anxiety and fear. Aim: This study aimed to examine the effects of using a virtual reality (VR) application before circumcision on the pre- and postoperative anxiety and fear levels and postoperative pain symptoms in children. Material and Methods: This randomized controlled experimental study included 5-to 10-year-old boys referred to a pediatric hospital for circumcision between June and September 2019. Randomization was performed using the randomized block design, and the subjects were divided into control (n = 38) and experimental (n = 40) groups. The data were collected using a participant information form, the children's fear scale (CFS), the children's anxiety meter scale (CAM-S), and the Wong-Baker Faces Pain Rating Scale; data were analyzed using SPSS 22.0 package program. The data were evaluated using descriptive statistics; the chi-square test was used to assess the sociodemographic data, the Mann-Whitney U test was used to compare two independent groups, the Wilcoxon T-test was used to compare intra-group preoperative and postoperative values, and the Spearman Correlation test was used to examine the relationship between anxiety, fear and pain scores. Keywords: Circumcision, child, virtual reality, anxiety, fear, pain.

Conditions

to Have a Circumcision Operation

Keywords

circumcision; child; virtual reality; anxiety; fear; pain

Outcome Measures

Primary Outcomes (3)

• Evaluate Anxiety with anxiety meter scale

  VR practice before circumcision reduces pre-operative and post-operative anxiety level

  VR practice one hour before circumcision

• Evaluate Fear with fear meter scale

  VR practice before circumcision reduces pre-operative and post-operative fear level

  VR practice one hour before circumcision

• Evaluate Pain with Wong-Baker Faces Pain Rating Scale

  VR practice before circumcision reduces postoperative pain symptoms

  VR practice one hour before circumcision

Study Arms (2)

VR Group

EXPERIMENTAL

The investigator explained the use of VR glasses to the children in the VR group. The investigator selected two VR programs to be watched by the children. In the VR program named Amazon, the child perceives himself to be walking among the trees in the Amazon forests. The other VR program gives the child a feeling of water skiing.

Procedure: Virtual Reality

Control Group

NO INTERVENTION

The same evaluations were performed in children in the control group who received routine clinical care.

Interventions

Virtual Reality PROCEDURE

The investigator explained the use of VR glasses to the children in the VR group. The investigator selected two VR programs to be watched by the children. In the VR program named Amazon, the child perceives himself to be walking among the trees in the Amazon forests. The other VR program gives the child a feeling of water skiing. Before commencement of the study, the VR applications were administered to five children aged between five and ten years, and these children shared no negative feedback about the VR programs. Before the surgery, the children were allowed to watch the VR program of their choice, the average duration of which was 4.5 minutes, using the VR glasses. Parts of the device that come in contact with the children's faces were cleaned before each application

VR Group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• agreement to participation in the study,
• age between 5 and 10 years,
• no vision or hearing problems,
• no history of surgical intervention,
• no chronic and mental health problems

You may not qualify if:

• no agreement to participation in the study,
• age lower than 5 and upper 10 years,
• to have vision or hearing problems,
• to have history of surgical intervention,
• to have chronic and mental health problems

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55250, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Esra Tural Büyük, Assoc. Prof.

  Ondokuz Mayıs University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sociodemographic data of the children and their mothers were collected using the participant information form. Then, the children rated their fear and anxiety on the scales using a pen. Similar assessments were performed by their mothers and the investigator. The investigator explained the use of VR glasses to the children in the VR group. After the surgery, the children, their mothers, and the investigator re-evaluated the fear and anxiety in children using the CFS and the CAM-S. The pain levels in children during the postoperative period were evaluated by both their mothers and the nurse. The same evaluations were performed in children in the control group who received routine clinical care.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This randomized controlled study was conducted a pediatric hospital in Turkey for circumcision between June and September 2019. The sample size for the study was calculated using the G-Power 3.0.10 program and t-test for comparison of two independent groups with an effect size of 0.8, an alpha level and margin of error of 0.05, and a power of 95%. The sample size was determined to be 70; each of the experimental and control groups included 35 children. Data were collected from 78 children. A randomized block design method was used to randomize the participants to the groups. The randomization list was prepared by a third person and was given to the investigator only during the application.

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: March 3, 2021
• Study Start: June 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 30, 2019
• Last Updated: March 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)