AzTrials
AzTrials

FearNCT06255548

Immersive Virtual Reality and Music During Circumcision in Children

A study testing Immersive virtual reality group and Music group in people with Fear and Anxiety, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 8 years, men onlyHealthy volunteers can take part
Conditions the study is for
Fear, Anxiety, Child
What is being tested?
Immersive virtual reality group and Music group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Aug 2022to 15 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 years
  • Men only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Afyonkarahisar Health Science University Health Science Faculty

    Afyonkarahisar

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Immersive Virtual Reality and Music on Anxiety, Fear, and Pain During Circumcision Surgery in Children: A Randomized Controlled Trial

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. Are immersive virtual reality and music interventions effective in reducing children's anxiety and fear levels during circumcision surgery?
  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.
Read the detailed description

Aim: Circumcision is one of the surgical procedures causing fear and pain in children. This study aimed to examine the effectiveness of immersive virtual reality (IVR) and music on children's anxiety, fear, and pain levels during circumcision surgery.

Methods:The participants were divided into three groups: Immersive virtual reality group (n=24), music group (n=24), and control group (n=24). Data were collected using a Participant Information Form, the Children's Anxiety Meter-Scale (CAM-S), the Children's Fear Scale (CFS), and the Wong-Baker Faces Pain Rating Scale (WBS). Anxiety and fear levels of the children were measured before, during, and after the circumcision operation and their pain levels were measured during and after circumcision. The study was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive statistics, analysis of variance, t-test, and Duncan and Bonferroni tests were performed for data analysis.

Intervention protocols: As a routine procedure in the clinic where the study was conducted, the children to be circumcised were admitted to the clinic in the morning on the day of the procedure, and routine preparations for the operation were completed. When the children and their families came to the clinic immediately after hospitalization, they were informed about the study by one of the researchers, and their written and verbal consent was obtained. Then the data were collected using an introductory information form, the Children's Anxiety Meter-Scale (CAM-S), and the Children's Fear Scale (CFS). Children who met the selection criteria were divided into groups by randomization method.

After the children in the experimental groups were taken to the waiting room in the operating room, they were informed by the researcher who would perform the intervention. The researcher explained the use of virtual reality glasses to the children in the IVR group and 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. The children were also informed that the intervention would be stopped if they experienced motion sickness, eye discomfort, headache, or earache. 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. Each child in the IVR group was allowed to choose the VR game he wanted to play during the circumcision. Routine procedures were applied for the control group.

Intervention phase:In this study, one group received IVR intervention, and the other group received music intervention to distract the child during the circumcision operation. One of the researchers (an academic with a PhD degree in pediatric nursing) was certified as a music therapy practitioner and had knowledge and experience in virtual reality. The interventions were carried out by this researcher. The researcher complied with the principles of medical and surgical asepsis in the operating room. Just before the intervention, the researcher put the virtual reality glasses on the children in the IVR group and gave the remote controls to their hands. The children in the music group wore music headphones.

Circumcision operations were performed in the same operating room setting by the same pediatric surgeon and operating room team (assistant physician, anesthesia technician, three nurses, and the researcher). The thermocautery assisted guillotine technique was performed in all children during circumcision. Each circumcision operation took an average of 15 minutes for all children in the experimental and control groups. This period included the child's entry and exit to and from the operating room. During this period, the parents of all children waited in the waiting room outside the operating room.

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.

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. The aforementioned VR video games are commercially available and were obtained from the Oculus Quest 2 Store (https://www.oculus.com/experiences/quest/).

A disposable silicone pad was placed on the Oculus Quest before each use. To minimize direct contact with the device, the patients wore disposable headgear and a face mask (personal protective equipment) before use. The parts of the device in contact with children's faces were cleaned before each intervention.

The children in the music group listened to music at the same volume (60 dB), with the same type of headphones, and the same iPad. The children listened to the music of their choice for 10 minutes after wearing the headphones. 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.

Children in the control group received routine care and no intervention was performed. Anxiety, fear, and pain of the children in the experimental and control groups were re-evaluated 10 minutes after circumcision by the children and an external observer using the Children's Anxiety Meter-Scale (CAM-S), the Children's Fear Scale (CFS), and the Wong-Baker Faces Pain Rating Scale (WBS).

Conditions
Fear, Anxiety, Child
Being tested
Immersive virtual reality group, Music group
Keywords
Immersive Virtual Reality, Music, Pain, Circumcision
Medical subject headings
Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immersive virtual reality groupOther

    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.

  • Music groupOther

    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.

Study groups in NCT06255548
Study groupRoleWhat they receive
Immersive virtual reality groupExperimentalDuring 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.
Receives: Other: Immersive virtual reality group
Music groupExperimentalThe 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.
Receives: Other: Music group
Control groupNo interventionChildren in the control group received routine care and no intervention was performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the procedure approximately 10 minutes

  2. 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.

    Measured: During the procedure approximately 10 minutes

  3. 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)

    Measured: During the procedure approximately 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start20 Aug 2022
  3. Primary completion30 Jun 2023
  4. Study completion15 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is a randomized controlled experimental study.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06255548
Sponsor's protocol ID
Afyonkarahisar
Status last verified
Feb 2024
First submitted
1 Feb 2024
Last updated
13 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34006462
  • 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.

    PubMed 32669215
  • 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.

    PubMed 36336624
  • 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.

    PubMed 37589631
  • 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.

    PubMed 35118971

Questions about this trial

What is this clinical trial studying?

A study testing Immersive virtual reality group and Music group in people with Fear and Anxiety, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Statistical difference between groups about anxiety scores (time frame: During the procedure approximately 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06255548, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in