Immersive Virtual Reality and Music During Circumcision in Children

NCT06255548 | Completed

• 1 other identifier: Afyonkarahisar
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to examine the effectiveness of immersive virtual reality (IVR) and music on children's anxiety, fear, and pain levels during circumcision surgery. The main question\[s\] it aims to answer are:

1. 1.Are immersive virtual reality and music interventions effective in reducing children's anxiety and fear levels during circumcision surgery?
2. 2.Are immersive virtual reality and music interventions effective in reducing children's pain levels during circumcision surgery? There were three groups in the study: control group (n:24), immersive virtual reality group (n:24), and music group (n:24). The control group did not undergo any intervention and only the routine procedure of the clinic was performed. The participants in the immersive virtual reality group played an interactive video game. The participants in the music group listened to music of their preference.

Conditions

Fear; Anxiety; Child

Keywords

Immersive Virtual Reality; Music; Pain; Circumcision

Outcome Measures

Primary Outcomes (3)

• Statistical difference between groups about anxiety scores

  Implementation of interventions aimed at reducing anxiety in experimental groups. Children's Anxiety Meter-Scale:This scale is used in clinical settings to assess children's anxiety during invasive procedures. Scores obtained from the scale range from 0 to 10.

  During the procedure approximately 10 minutes

• Statistical difference between groups about fear scores

  Implementation of interventions aimed at reducing fear in experimental groups. Children's Fear Scale:This scale is used in clinical settings to assess children's fear during invasive procedures.The scale consists of five gender-neutral facial expressions, ranging from neutral on the far left to extremely fearful on the far right. The evaluation of facial expressions ranges between 0-4 points.

  During the procedure approximately 10 minutes

• Statistical difference between groups about pain scores

  Implementation of interventions aimed at reducing pain in experimental groups. Wong-Baker Faces Pain Rating Scale:This scale was developed by Wong and Baker to evaluate pain in children aged 3-18. Scores on the numerical rating scale range from 0 to 10. The scale shows a series of faces ranging from a smiling face (0=very happy/no pain) to a crying face (10=high pain)

  During the procedure approximately 10 minutes

Study Arms (3)

Immersive virtual reality group

EXPERIMENTAL

During the circumcision operation, the IVR group received both routine care and VR game. The children were allowed to play the virtual reality game of their choice. The children in the IVR group had an interactive gaming experience for 10 minutes with the game of their choice, using the remote controls while lying on their backs on the operating table during circumcision.

Other: Immersive virtual reality group

Music group

EXPERIMENTAL

The researcher explained the use of music headphones to the children in the music group. Each child in the music group was allowed to choose the music he wanted to listen to during the circumcision. In the interview with the children in the music group, the type of music they listened to in their daily lives was asked and the music they wanted to listen to during circumcision was determined.

Other: Music group

Control group

NO INTERVENTION

Children in the control group received routine care and no intervention was performed.

Interventions

Immersive virtual reality group OTHER

The children in the IVR group were offered two video games from the Oculus Quest gallery. These games were Ocean Rift and Epic Roller Coaster-T-Rex Kingdom. Ocean Rift is the world's first VR water safari park. It has 12 different marine animals such as dolphins, sharks, and turtles and a habitat. Here one can visit a vibrant underwater world that extends all the way to the Arctic and Atlantis. Epic Roller Coaster-T-Rex Kingdom takes one on a roller coaster ride through the Age of Dinosaurs. There are more than 10 species of dinosaurs such as terrestrial, flying, herbivorous and carnivorous.

Immersive virtual reality group

Music group OTHER

In musical interventions, it is recommended to play music chosen by individuals. Disposable ear pads were used for each child and the headphones were cleaned after each intervention.

Music group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Circumcision in a pediatric surgery clinic
• Agreeing to participate in the study
• Having no visual and hearing problems, having no history of surgical intervention, and having no chronic pain or mental health problems

You may not qualify if:

• Presence of contraindications for the procedure (hypospadias, epispadias, bleeding disorders, anatomical disorders),
• Use of any painkillers 24 hours before the procedure,
• Presence of communication problems.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Science University Health Science Faculty

Afyonkarahisar, Turkey (Türkiye)

Location

Related Publications (5)

• Buyuk ET, Odabasoglu E, Uzsen H, Koyun M. The effect of virtual reality on Children's anxiety, fear, and pain levels before circumcision. J Pediatr Urol. 2021 Aug;17(4):567.e1-567.e8. doi: 10.1016/j.jpurol.2021.04.008. Epub 2021 Apr 21.

  PMID: 34006462 BACKGROUND

• Suzan OK, Sahin OO, Baran O. Effect of Puppet Show on Children's anxiety and pain levels during the circumcision operation: A randomized controlled trial. J Pediatr Urol. 2020 Aug;16(4):490.e1-490.e8. doi: 10.1016/j.jpurol.2020.06.016. Epub 2020 Jun 20.

  PMID: 32669215 BACKGROUND

• Luo W, Chen C, Zhou W, Cao A, Zhu W, Zhou Y, Xu Z, Wang J, Zhu B. Biophilic virtual reality on children's anxiety and pain during circumcision: A randomized controlled study. J Pediatr Urol. 2023 Apr;19(2):201-210. doi: 10.1016/j.jpurol.2022.10.023. Epub 2022 Oct 20.

  PMID: 36336624 BACKGROUND

• Yeniay D, Tamdo An L, Yucak Ozdemir A, Ak An LO, Kay R SU. Effects of Videos and Therapeutic Music on Preoperative Anxiety and Postoperative Anxiety and Pain Levels in Boys Who Undergo Circumcision. J Perianesth Nurs. 2023 Dec;38(6):918-924. doi: 10.1016/j.jopan.2023.04.007. Epub 2023 Aug 16.

  PMID: 37589631 BACKGROUND

• Gezginci E, Suluhan D, Caliskan MB. Is tablet-based interactive distraction effective on pain and anxiety during circumcision in children? A randomized controlled trial. Turk J Urol. 2021 Nov;47(6):518-525. doi: 10.5152/tud.2021.21228.

  PMID: 35118971 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Hamide Nur Çevik Özdemir, PhD

  Afyonkarahisar Health Science University Health Science Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor) Triple-blind (i.e., triple-masking) studies are randomized experiments in which the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention, and (c) the individual(s) who assess the outcomes
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.prof.

Model Details: The study is a randomized controlled experimental study.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 13, 2024
• Study Start: August 20, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 15, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)