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Completed

NCT Number: NCT04824690

The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children

An immersive virtual reality (VR) tour of the operating theater before surgery could reduce preoperative anxiety. The aims of this study were to analyze whether a preoperative virtual reality tour shows a reduction in anxiety in children and an increase in parental satisfaction.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Satisfaction Signs and Symptoms

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bolu Abant İzzet Baysal University

Bolu, 14030, Turkey (Türkiye)

About this study

Children who will undergo surgery for the first time and their families were randomly allocated into the control or VR group. The control group received conventional education regarding the perioperative process of surgery. The VR group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. The main finding was preoperative anxiety evaluated using the Children's State Anxiety (CSA) before surgery. Secondary findings included children's postoperative pain ratings using Wong-Baker Faces Pain Rating Scale and parental satisfaction scores using PedsQL Health Care Satisfaction Scale

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children 4-10 years old
  • ASA grade I or II
  • General anesthesia
  • Elective surgery

Exclusion criteria

  • Children who have had previous surgery history
  • Local anesthesia or emergency surgeries
  • Premature or congenital disease history
  • Having visual and hearing impairment
  • Mental and developmental retardation
  • Having a history of epilepsy and seizures
  • Patients taking psychoactive drugs

Treatment and study plan

Virtual reality

Device

Immersive virtual reality tour of the operating theatre before surgery and distraction methods both using VR headset

Primary outcomes

  1. Preoperative anxiety assessed by the Children's State Anxiety (CAM-S)

    Time frame: This is measured right before the child goes into operating theatre / separating from his/her parents.

    The CAM-S scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line on the thermometer showing how much worry or nervousness you feel. Min score : 0 & Max score : 10

Secondary outcomes

  1. Postoperative Pain assessed by the Wong-Baker Faces Pain Rating Scale

    Time frame: This is measured immediately after the surgery.

    The scale is used around the world with people ages 3 and older. Min score : 0 & Max score : 5

  2. Parental Satisfaction assessed by PedsQL Health Care Satisfaction Scale

    Time frame: This is measured immediately after the intervention.

    Parents answered the following scale questions by indicating how satisfied they are with the services provided to them and their children. Min score : 0 & Max score : 100

  3. Postoperative anxiety assessed by the Children's State Anxiety (CAM-S)

    Time frame: This is measured immediately after the surgery.

    The CAM-S scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line on the thermometer showing how much worry or nervousness you feel. Min score : 0 & Max score : 10

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

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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