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

NCT ID: NCT04824690

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Anxiety Pain Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Virtual Reality Group

The virtual reality group watched a 1.5-minute VR video showing the operating theater and explaining the perioperative process. After the surgery, this group watched cartoons during the first standard nursing procedures after the effect of the anesthesia wore off.

Group Type EXPERIMENTAL

Virtual reality

Intervention Type DEVICE

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

Control Group

The control group received conventional care and education regarding the perioperative process of surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Aykut Turgut

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bolu Abant İzzet Baysal University

Bolu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019_78

Identifier Type: -

Identifier Source: org_study_id

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