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

The Effect of Preoperative Virtual Reality Cartoon Viewing on Postoperative Pain and Anxiety in Children Undergoing Tonsillectomy and Adenoidectomy

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.

Study Overview

• Status: Completed
• Conditions: Tonsillectomy; Adenoidectomy
• Intervention / Treatment: Other: Virtual Reality Group

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Buca
    • Izmir, Buca, Turkey, 35400
      • Izmir Tinaztepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

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
• Children or parents who meet the inclusion criteria but do not wish to wear the virtual reality headset (VRH) glasses
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measure	Pain Score: The Visual Analog Scale (VAS) was used to measure pain intensity in children during the postoperative period following tonsillectomy and adenoidectomy. The children were assessed using the Visual Analog Scale (VAS) before surgery, immediately after returning to the ward post-surgery, and 8 hours after surgery.The Visual Analog Scale (VAS) ranges from 0 to 10, with 0 indicating no pain and 10 representing the worst possible pain. Higher scores indicate greater pain intensity.	Preoperative, immediately postoperative, 8 hours postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tertiary Outcome Measure	Anxiety Score: The Perioperative Multidimensional Anxiety Scale for Children is a visual analog scale consisting of 5 items, each scored between 0 and 100. The scale was used to measure anxiety levels in children during the perioperative period.	Preoperative, immediately postoperative, 8 hours postoperative

Collaborators and Investigators

• Sponsor: Izmir Tinaztepe University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Actual): June 4, 2024
• Study Completion (Actual): July 13, 2024

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: January 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 1, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Virtual Reality; Cartoon; Anxiety Level; Pain Level
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: İzmirTınaztepeÜ-B.Dizer-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No