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

• ClinicalTrials.gov Identifier: NCT04778683
• Recruitment Status: Completed
• First Posted: March 3, 2021
• Last Update Posted: March 3, 2021
• Sponsor: Ondokuz Mayıs University
• Information provided by (Responsible Party): Hatice Uzşen, Ondokuz Mayıs University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
to Have a Circumcision Operation	Procedure: Virtual Reality	Not Applicable

Detailed Description:

This randomized controlled study was included 5-to 10-year-old boys who were referred to 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 98 children. Of them, 14 children were excluded from the study because two could not obtain approval from their families to participate in the study, four had previous surgical interventions, six had chronic and mental illnesses, and two had vision problems. The inclusion criteria for the study were agreement to participation in the study, age between 4 and 10 years, no vision or hearing problems, no history of surgical intervention, and no chronic and mental health problems. Children who met the inclusion criteria and who had written and verbal consents from their parents for participation in the study were divided into 2 groups. The experimental group consisted of 40 children who received a VR application, and the control group consisted of 38 children who received standard healthcare. 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.

Instruments The data were collected using a participant information form to obtain details about baseline characteristics; children's fear scale (CFS) and children's anxiety meter scale (CAM-S) were used to evaluate fear and anxiety in children during both the pre- and postoperative periods, and the Wong-Baker faces pain rating scale (WBS) was used to evaluate the levels of postoperative pain in children. A white colored "VR BOX 3.0" with VR glasses (a headset with a screen covering the children's eyes) was used in this study. It was compatible with iOS and Android operating systems and 4-6-inch screen smartphones. The VR device, which is activated through applications installed on smartphones, divides the image into two equal windows, providing the necessary viewfinder range for panoramic view. The distance between the mobile phone and the lens can be adjusted for each user. The VR glasses do not require any power or electrical connection, except the mobile phone, during their use. The weight of the VR glasses is 0.414 kg. Soundproof headsets are used to provide immersive VR.

Procedure 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. 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. 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: 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.
• Primary Purpose: Supportive Care
• Official Title: THE EFFECT OF VIRTUAL REALITY ON CHILDREN'S ANXIETY, FEAR, AND PAIN LEVELS BEFORE CIRCUMCISION IN TURKEY
• Actual Study Start Date: June 1, 2019
• Actual Primary Completion Date: September 1, 2019
• Actual Study Completion Date: September 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: VR Group; 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; 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
No Intervention: Control Group; The same evaluations were performed in children in the control group who received routine clinical care.

Outcome Measures

Primary Outcome Measures :

1. Evaluate Anxiety with anxiety meter scale [ Time Frame: VR practice one hour before circumcision ]
   VR practice before circumcision reduces pre-operative and post-operative anxiety level
2. Evaluate Fear with fear meter scale [ Time Frame: VR practice one hour before circumcision ]
   VR practice before circumcision reduces pre-operative and post-operative fear level
3. Evaluate Pain with Wong-Baker Faces Pain Rating Scale [ Time Frame: VR practice one hour before circumcision ]
   VR practice before circumcision reduces postoperative pain symptoms

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Turkey

Ondokuz Mayis University

Samsun, Atakum, Turkey, 55250

Sponsors and Collaborators

Ondokuz Mayıs University

Investigators

• Study Chair: Esra Tural Büyük, Assoc. Prof.; Ondokuz Mayıs University

More Information

• Responsible Party: Hatice Uzşen, Principal Investigator, Ondokuz Mayıs University
• ClinicalTrials.gov Identifier: NCT04778683
• Other Study ID Numbers: OMU-B.30.2.ODM.0.2
• First Posted: March 3, 2021
• Last Update Posted: March 3, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hatice Uzşen, Ondokuz Mayıs University:

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

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders