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Clinical Trials/NCT06763276
NCT06763276
Completed
Not Applicable

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

Izmir Tinaztepe University1 site in 1 country102 target enrollmentNovember 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tonsillectomy
Sponsor
Izmir Tinaztepe University
Enrollment
102
Locations
1
Primary Endpoint
Vital signs
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2023
End Date
July 13, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Izmir Tinaztepe University
Responsible Party
Principal Investigator
Principal Investigator

Berna Dizer

Assistant professor

Izmir Tinaztepe University

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

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

Outcomes

Primary Outcomes

Vital signs

Time Frame: 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)

Time Frame: 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)

Time Frame: Preoperative, immediately postoperative, and 8 hours postoperative

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

Body Temperature (°C)

Time Frame: Preoperative, immediately postoperative, and 8 hours postoperative

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

Hemoglobin (g/dL)

Time Frame: 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)

Time Frame: 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)

Time Frame: Preoperative and 24 hours postoperative

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

Secondary Outcomes

  • Secondary Outcome Measure(Preoperative, immediately postoperative, 8 hours postoperative)

Study Sites (1)

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