Effect of Virtual Tour of the Operating Theater on Fear and Anxiety of Preoperative Children

NCT05401539 | Unknown

• 2 other identifiers: MCBU-KARAARSLAN2020-083
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Experiences such as hospitalization, medical or surgical procedures are stressful, complex and threatening, especially for children and their families. Among the first crisis symptoms that children are faced with are illness, hospitalization and surgery anxiety. There is a direct relationship between the fear and anxiety experienced by children and their parents during the pre-operative processes. Therefore, ensuring not only the psychological but also physiological preparation of both the children and their parents before the surgery is of great importance. In the hospital, applying distraction methods appropriate for the age period of children and conveying procedural information to them simultaneously are difficult and challenging. In such situations, in clinical settings, virtual reality technology can be used at any time and place without requiring extra workforce to eliminate or reduce children's fear and anxiety. Virtual reality applications, as a distracting therapeutic method, are a fun, calming, safe, accessible, effective and acceptable intervention that can be used for the management of acute pain, fear and anxiety in pediatric patients. Such applications can affect children visually, aurally and contextually. Because they are different from common distraction methods used by children such as reading books, playing with toys, watching television or movies, playing a two-dimensional video game or game console. Virtual reality (VR) is used to distract children's attention to reduce fear and anxiety before surgery. A VR tour of the operating theater can provide a realistic experience for children. The aim in this study was to investigate the effect of an actual operating theater tour which is watched by children aged 6-12 years wearing a 3D virtual headset on their fear and anxiety.

Conditions

Preoperative Anxiety

Keywords

Child,fear,anxiety,operating theater tour,virtual reality

Outcome Measures

Primary Outcomes (1)

• Sociodemographic Information Form

  The Sociodemographic Information Form will administere to the children aged 6-12 years who will meet the inclusion criteria and their parents and agreed to participate in the study on the morning of the surgery day.

  in the preoperative period. it will take approximately 10-15 minutes to fill out the form.

Secondary Outcomes (3)

• Determining the preoperative anxiety scores of children

  it will take approximately 10-15 minutes to fill out the form.

• Determining the preoperative fear scores of children

  it will take approximately 10-15 minutes to fill out the form.

• Determining the preoperative anxiety scores of parents

  it will take approximately 10-15 minutes to fill out the form.

Study Arms (2)

Group 1: VR- Operating Theater Tour Group

EXPERIMENTAL

The 7-minute operating theatre tour, which describes the preparation process for the surgery, covers the following process: 6-12-year-old children's leaving their room, entering the operating theatre, and meeting the surgery team after they are taken to the operating theatre. The tour ends in the postoperative recovery unit. The actual operating theatre tour also will include information about how and when the child would wear the surgical gown, and how he or she would go to the operating theatre. In order to shoot the operating theatre tour scenes in the most appropriate way, all the procedures to be applied to the children to be operated will observe by the researcher in the pre-, intra- and post-operative periods. The scenario created for the scene shots will reviewe by experts in the field of filming and the final version will decide. The children who will have surgery will watch the real operating theatre tour with the cardboard VR headset.

Device: Cardboard VR

Group 2: VR- Documentary Film Group

EXPERIMENTAL

The children in this group will watch the 5-minute musical documentary film featuring farm animals suitable for their age group with a cardboard VR headset. This group will form as a parallel group to determine whether the VR-Operating theatre Tour or the VR- Documentary Film is more effective.

Device: Cardboard VR

Interventions

Cardboard VR DEVICE

Google Cardboard is a discontinued virtual reality (VR) platform developed by Google. Named for its fold-out cardboard viewer into which a smartphone is inserted, the platform was intended as a low-cost system to encourage interest and development in VR applications. To use the platform, users run Cardboard-compatible mobile apps on their phone, place it into the back of the viewer, and view content through the lenses. The parts that make up a Cardboard viewer are a piece of cardboard cut into a precise shape, magnets or capacitive tape, a hook and loop fastener, a rubber band, and an optional near field communication tag. Smartphone is inserted in the back of the device and held in place by the selected fastening device. A Google Cardboard-compatible app splits the smartphone display image into two, one for each eye, while also applying barrel distortion to each image to counter pincushion distortion from the lenses.The result is a stereoscopic image with a wide field of view.

Group 1: VR- Operating Theater Tour Group; Group 2: VR- Documentary Film Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children are included in the study if they are aged between 6 and 12 years; have surgery for the first time; have outpatient surgery and only one operation at a time; could speak Turkish.

You may not qualify if:

• Children will exclude in the study if they have genetic or congenital disease, have a chronic disease, and have previous surgery

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Surgical clinic of Manisa Celal Bayar University Hospital

Manisa, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the process of assignment of children into groups, randomization is achieved in the computer by stratifying them in terms of sex and age variables (https://www.randomizer.org/).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, pediatric nursing research assistant

Model Details: This randomized controlled and experimental study will be conducted in the pediatric surgery clinic of a university hospital. Randomization of the children will achieve by checking the children at the beginning of each week and on the day of surgery according to the planned surgery lists. The VR tour provided with a 360° video is prepared to make the child be acquainted with the preoperative preparation process.The VR tour video feature actual nurses and physicians working in the surgery clinic and operating theatre. A professional VR company will performe filming in the hospital's operating theatre. The VR video is then will turn into an app for mobile devices. The children will assign into the VR-Documentary Film Group, VR- Operating Theater Tour Group and Control Group. A parallel trial design will use. Cardboard VR glasses, a non-pharmacological approach and a 3D imaging method, will use by the children to watch the movies.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

TU (1)