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

NCT06763276 | Completed

• 1 other identifier: İzmirTınaztepeÜ-B.Dizer-001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillectomy; Adenoidectomy

Keywords

Virtual Reality; Cartoon; Pain Level; Anxiety Level

Outcome Measures

Primary Outcomes (7)

• Vital signs

  Systolic Blood Pressure (mmHg) Description: Systolic blood pressure levels measured during the perioperative period.

  Preoperative, immediately postoperative, and 8 hours postoperative.

• Diastolic Blood Pressure (mmHg)

  Diastolic blood pressure levels will be measured to assess changes in blood pressure during the perioperative period.

  Preoperative, immediately postoperative, and 8 hours postoperative

• Heart Rate (bpm)

  Heart rate will be measured to monitor cardiac activity during the perioperative period.

  Preoperative, immediately postoperative, and 8 hours postoperative

• Body Temperature (°C)

  Body temperature will be measured to observe temperature changes during the perioperative period.

  Preoperative, immediately postoperative, and 8 hours postoperative

• Hemoglobin (g/dL)

  Hemoglobin levels will be measured preoperatively and within 24 hours postoperatively to evaluate changes in blood parameters during the perioperative period.

  Preoperative and 24 hours postoperative

• Creatinine (mg/dL)

  Creatinine levels will be measured preoperatively and within 24 hours postoperatively to monitor renal function during the perioperative period.

  Preoperative and 24 hours postoperative

• Glucose (mg/dL)

  Glucose levels will be measured preoperatively and within 24 hours postoperatively to assess perioperative glucose regulation

  Preoperative and 24 hours postoperative

Secondary Outcomes (1)

• Secondary Outcome Measure

  Preoperative, immediately postoperative, 8 hours postoperative

Other Outcomes (1)

• Tertiary Outcome Measure

  Preoperative, immediately postoperative, 8 hours postoperative

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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.

Other: Virtual Reality Group

Control Group

NO INTERVENTION

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.

Interventions

Virtual Reality Group 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.

Virtual Reality Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Izmir Tinaztepe University: lead

Study Sites (1)

Izmir Tinaztepe University

Izmir, Buca, 35400, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40934240 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: January 8, 2025
• Study Start: November 10, 2023
• Primary Completion: June 4, 2024
• Study Completion: July 13, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)