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

Not Applicable

Completed

• Conditions: Tonsillectomy; Adenoidectomy

• Registration Number: NCT06763276
• Lead Sponsor: Izmir Tinaztepe University

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.

Study Timeline

• Study Start: 2023-11-10
• Primary Completion: 2024-06-04
• Study Completion: 2024-07-13
• Study First Submitted: 2024-07-26
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vital signs	Preoperative, immediately postoperative, and 8 hours postoperative.	Systolic Blood Pressure (mmHg) Description: Systolic blood pressure levels measured during the perioperative period.
Diastolic Blood Pressure (mmHg)	Preoperative, immediately postoperative, and 8 hours postoperative	Diastolic blood pressure levels will be measured to assess changes in blood pressure during the perioperative period.
Heart Rate (bpm)	Preoperative, immediately postoperative, and 8 hours postoperative	Heart rate will be measured to monitor cardiac activity during the perioperative period.
Body Temperature (°C)	Preoperative, immediately postoperative, and 8 hours postoperative	Body temperature will be measured to observe temperature changes during the perioperative period.
Hemoglobin (g/dL)	Preoperative and 24 hours postoperative	Hemoglobin levels will be measured preoperatively and within 24 hours postoperatively to evaluate changes in blood parameters during the perioperative period.
Creatinine (mg/dL)	Preoperative and 24 hours postoperative	Creatinine levels will be measured preoperatively and within 24 hours postoperatively to monitor renal function during the perioperative period.
Glucose (mg/dL)	Preoperative and 24 hours postoperative	Glucose levels will be measured preoperatively and within 24 hours postoperatively to assess perioperative glucose regulation

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measure	Preoperative, immediately postoperative, 8 hours postoperative	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.

Trial Locations

Locations (1)

Izmir Tinaztepe University; 🇹🇷 Izmir, Buca, Turkey