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The Effectiveness of Using Virtual Reality Technology for Surgery-related Anxiety among Adults:Protocol for a single-centre randomised controlled trial

The Effectiveness of Using Virtual Reality Technology for Periopeartive Anxiety among Adults undergoing Elective Surgery:Protocol for a single-centre randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001350910
Enrollment
98
Registered
2020-12-14
Start date
2021-11-10
Completion date
2022-11-01
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this research is to test if a brief Virtual Reality session reduces anxiety levels in people having elective surgery. Managing anxiety in people having surgery is important because high levels of anxiety can lead to increased pain, surgical infection, poorer wound healing and delayed recovery. Previous research that has used VR has shown that it reduces surgery-related anxiety and leads to better surgical outcomes. This is a randomised controlled trial which means that participants are randomly allocated to either receive the Virtual Reality session or not. Everyone who agrees to participate will be asked to: 1- Have heart rate taken at 3 time-point, two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. 2- Rate your anxiety level on a 100-points scale (zero means you don’t feel anxious, and 100 means you feel extremely anxious) two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. 3- Provide a saliva sample at 3 time-points to test your stress levels two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. The saliva is taken from your mouth using a cotton swab by yourself, and instruction of use will be provided to you. 4- Rate your pain level on a 100-points scale (zero means you don’t have any pain, and 100 means you feel the worst pain) two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. 5- Complete a 39 item satisfaction questionnaire before you are discharged from the hospital. 6- Allow the researcher to access your medical record to extract the following information: type of surgery, type of anaesthesia, any medications given before surgery and length of hospital stay. Those people randomly allocated to receive the Virtual Reality session will be asked to: 1- Use a Virtual Reality device to watch and listen to a nature scene for 5-10 minutes in the waiting area before surgery. 2- Complete a 13 item questionnaire after the virtual reality session asking about any side effects. Those people randomly allocated to the control group will receive: 1- Routine preoperative care only.

Interventions

VIRTUAL REALITY INTERVENTION The participants will be asked to wear the VR headset for 10 minutes, which has been suggested in the literature to be the optimal time frame for VR without adverse side effects. The participants will be seated in the preoperative holding area while emersed in a VR nature scene with accompanying nature sounds. The preoperative holding area has been selected for administration of the intervention because evidence suggests preoperative anxiety levels among adult surgi

VIRTUAL REALITY INTERVENTION The participants will be asked to wear the VR headset for 10 minutes, which has been suggested in the literature to be the optimal time frame for VR without adverse side effects. The participants will be seated in the preoperative holding area while emersed in a VR nature scene with accompanying nature sounds. The preoperative holding area has been selected for administration of the intervention because evidence suggests preoperative anxiety levels among adult surgical patients peak in the preoperative holding area. The VR will be used for relaxation purposes with nine natural scenes combined with natural sounds and music, for the participant to select from: blue moon; red savanna; blue ocean; green meadows; black beginning; white winter; blue deep; red fall, and the orange sunset . The participant's face and forehead will be cleaned using skin-friendly antibacterial cleaning wipes before using the VR device. Disposable hygiene covers will be used to protect the VR device. The researcher will provide the intervention and monitor the participant for adverse side effects such as headache, nausea, vomiting, sweating, fatigue, drowsiness, disorientation, and apathy throughout the session.

Sponsors

Umm Al-Qura University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients will be eligible for inclusion if they are 18 years old and over; scheduled for elective surgery; able to understand English and follow instructions. Screening: Patients who meet the above inclusion criteria will be screened for their anxiety level using The Amsterdam Preoperative Anxiety and Information score(APAIS). The screening will be done on the day of their surgery in the preoperative holding area. Patients with moderate to high level of preoperative anxiety - defined as a preoperative anxiety score greater than or equal 11 , will be included.

Exclusion criteria

Patients will be eligible for inclusion if they are 18 years old and over, scheduled for elective surgery, can understand English, and can follow instructions. Patients will be excluded if they are scheduled for day surgery; have a history of seizures or motion sickness; or are unable to complete a self-reported questionnaire.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026