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Completed

NCT Number: NCT06763276

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

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.

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Key information

Conditions

Tonsillectomy Adenoidectomy

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Tinaztepe University

Izmir, Buca, 35400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Group

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  1. Secondary Outcome Measure

    Time frame: 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.

Other outcomes

  1. Tertiary Outcome Measure

    Time frame: Preoperative, immediately postoperative, 8 hours postoperative

    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.

Sponsors and collaborators

Lead sponsor

Izmir Tinaztepe University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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