Preoperative VR Cartoon Viewing Reduces Postoperative Pain and Anxiety in Pediatric Tonsillectomy Patient

NCT ID: NCT06763276

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2024-07-13

Brief Summary

The aim of this study is to determine the effect of watching a cartoon with a virtual reality headset before surgery on the pain and anxiety levels of children aged 7-12 years.

Detailed Description

The aim of this study is to determine the effect of watching a cartoon with a virtual reality headset before surgery on the pain and anxiety levels of children aged 7-12 years. In line with this aim, children aged 7-12 who were scheduled for tonsillectomy and adenoidectomy at the Ear, Nose, and Throat Department of Uşak University Education and Research Hospital were shown a cartoon with a virtual reality headset before surgery, and their pain and anxiety levels were examined. The study was conducted as a randomized controlled experimental study at the Ear, Nose, and Throat Unit of Uşak University Education and Research Hospital. The population of the study consisted of children aged 7-12 who applied for tonsillectomy and adenoidectomy surgery at the Ear, Nose, and Throat Unit of Uşak University Education and Research Hospital. The sample of the study included a total of 102 children, with 51 in the experimental group and 51 in the control group, who met the research criteria and volunteered to participate in the study between November 10, 2023, and June 1, 2024. Data collection tools included the informed consent form, sociodemographic questionnaire, vital signs assessment form, Visual Analog Scale, and the Perioperative Multidimensional Anxiety Scale for children.

Conditions

Tonsillectomy; Adenoidectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Group

A meeting was conducted with the children and their parents. Information about the content of the research was provided. Consent forms were completed by the children and their parents. Instructions on how to use the virtual reality headset were given to the children and their parents.

Mothers were asked to comfort and caress their children during the preoperative period.

The first 15-20 minutes of the cartoon were shown to the children before the surgery. After watching the cartoon, the children were sent for tonsillectomy and adenoidectomy surgery. The remainder of the cartoon was shown one hour after the surgery once the child had settled in the recovery room.

Before the tonsillectomy and adenoidectomy surgery, immediately after the child returned to the ward post-surgery, and 8 hours after the surgery:

The child's vital signs were recorded. The child's anxiety and pain scores were assessed.

Group Type: EXPERIMENTAL

Virtual Reality Group

Intervention Type: OTHER

In the study, a 400-gram virtual reality (VR) headset with an anti-reflective lens system was used, compatible with all earphones with screens ranging from 4.5 to 7.0 inches. The virtual reality (VR) headset, which was lightweight enough for children to wear, was supported on three sides to fit securely on the children's heads and was disinfected after each use. For the experimental group, the compartment at the front of the virtual reality (VR) headset was removed. The earphone was placed into the removed compartment, which was then reinserted. Subsequently, the YouTube virtual reality (VR) feature was activated on the phone, making it ready for viewing.

Control Group

Consent forms were completed by the children and their parents. Mothers were asked to comfort and caress their children.

Before the tonsillectomy and adenoidectomy surgery, immediately after the child returned to the ward post-surgery, and 8 hours after the surgery:

The child's vital signs were recorded. The child's anxiety and pain scores were assessed. The children in the control group were allowed to watch the cartoon via virtual reality (VR) after all data for the research had been collected to ensure ethical equality.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Group

In the study, a 400-gram virtual reality (VR) headset with an anti-reflective lens system was used, compatible with all earphones with screens ranging from 4.5 to 7.0 inches. The virtual reality (VR) headset, which was lightweight enough for children to wear, was supported on three sides to fit securely on the children's heads and was disinfected after each use. For the experimental group, the compartment at the front of the virtual reality (VR) headset was removed. The earphone was placed into the removed compartment, which was then reinserted. Subsequently, the YouTube virtual reality (VR) feature was activated on the phone, making it ready for viewing.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Child's criteria:

• Children aged between 7 and 12 years
• Ability to understand pain and anxiety scales
• Possession of communication skills
• Absence of mental issues
• Absence of physical illnesses
• Absence of chronic illnesses
• Willingness of the child and family to participate in the study
• No visual, hearing, or speech problems

• Children who need to wear glasses other than the virtual reality headset (VRH)
• Children with hearing problems
• Children who do not wish to watch the shrek cartoon

Exclusion Criteria

• Children younger than 7 years or older than 12 years
• Presence of any chronic illness that could affect pain and anxiety levels
• Presence of psychosocial issues

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Izmir Tinaztepe University

OTHER

Sponsor Role: lead

Responsible Party

Berna Dizer

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Izmir Tinaztepe University

Izmir, Buca, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Mersin SK, Dizer B, Tuna A. Effect of preoperative virtual reality cartoon viewing on postoperative pain and anxiety in children undergoing tonsillectomy and adenoidectomy: A randomized controlled trial. PLoS One. 2025 Sep 11;20(9):e0331793. doi: 10.1371/journal.pone.0331793. eCollection 2025.

Reference Type: DERIVED

PMID: 40934240 (View on PubMed)

Other Identifiers

İzmirTınaztepeÜ-B.Dizer-001

Identifier Type: -

Identifier Source: org_study_id