An interventional study of Virtual Reality Group in Tonsillectomy and Adenoidectomy, sponsored by Izmir Tinaztepe University. Completed at 1 site in Turkey. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by Izmir Tinaztepe University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 102 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
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Child's criteria:
Exclusion Criteria:
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
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.
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.
Vital signs
Systolic Blood Pressure (mmHg) Description: Systolic blood pressure levels measured during the perioperative period.
Time frame: 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.
Time frame: Preoperative, immediately postoperative, and 8 hours postoperative
Heart Rate (bpm)
Heart rate will be measured to monitor cardiac activity during the perioperative period.
Time frame: Preoperative, immediately postoperative, and 8 hours postoperative
Body Temperature (°C)
Body temperature will be measured to observe temperature changes during the perioperative period.
Time frame: 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.
Time frame: 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.
Time frame: Preoperative and 24 hours postoperative
Glucose (mg/dL)
Glucose levels will be measured preoperatively and within 24 hours postoperatively to assess perioperative glucose regulation
Time frame: Preoperative and 24 hours postoperative
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.
Time frame: Preoperative, immediately postoperative, 8 hours postoperative
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.
Time frame: Preoperative, immediately postoperative, 8 hours postoperative
Plan to share: No
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Izmir Tinaztepe University