Clinical trial NCT06763276: Preoperative VR Cartoon Viewing Reduces Postoperative Pain and Anxiety in Pediatric Tonsillectomy Patient
Official title: The Effect of Preoperative Virtual Reality Cartoon Viewing on Postoperative Pain and Anxiety in Children Undergoing Tonsillectomy and Adenoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillectomy
Adenoidectomy
Keywords: Virtual Reality
Cartoon
Pain Level
Anxiety Level
Lead sponsor: Izmir Tinaztepe University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 102
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Vital signs
timeFrame: Preoperative, immediately postoperative, and 8 hours postoperative.
measure: Diastolic Blood Pressure (mmHg)
timeFrame: Preoperative, immediately postoperative, and 8 hours postoperative
measure: Heart Rate (bpm)
timeFrame: Preoperative, immediately postoperative, and 8 hours postoperative
measure: Body Temperature (°C)
timeFrame: Preoperative, immediately postoperative, and 8 hours postoperative
measure: Hemoglobin (g/dL)
timeFrame: Preoperative and 24 hours postoperative
measure: Creatinine (mg/dL)
timeFrame: Preoperative and 24 hours postoperative
measure: Glucose (mg/dL)
timeFrame: Preoperative and 24 hours postoperative
Secondary outcomes:
measure: Secondary Outcome Measure
timeFrame: Preoperative, immediately postoperative, 8 hours postoperative
Other outcomes:
measure: Tertiary Outcome Measure
timeFrame: Preoperative, immediately postoperative, 8 hours postoperative
Locations:
city: Izmir
country: Turkey
facility: Izmir Tinaztepe University
state: Buca
Study officials:
References: