The Effect of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients

NCT05718661 | Completed

• 1 other identifier: TUTF-GOBAEK 2022/240
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Hospitalization, medical interventions to be performed, and uncertainties specific to surgical intervention create a certain level of anxiety in the patient. It is known that being in the hospital negatively affects the coping mechanisms of the patient. In the pre-surgical period, the nurse's practices that will facilitate the patient's coping with the situation and managing his anxiety have a positive effect on anxiety during and after surgery and on anxiety-related symptoms. For these reasons, it is aimed to determine the effect of virtual reality on pre-surgical anxiety in this study.The hypothesis of the study is that watching videos with virtual glasses will reduce preoperative anxiety.

Conditions

Anxiety

Keywords

virtual reality; abdominal surgery; randomised controlled trial

Outcome Measures

Primary Outcomes (3)

• Preoperative Anxiety Level-1

  Visual Analogue Scale-Anxiety (VAS-A):This scale was used to evaluate patients' preoperative anxiety levels on the morning. It consists of a horizontal line on the paper with scored from "0" for "experiencing no anxiety" on the left side to "10" for " experiencing too much anxiety" on the right side.It is also reported to be valid in evaluating preoperative anxiety of surgery patients. The anxiety levels of a total of 96 patients were evaluated subjectively using the VAS-A scale. Patients marked the level of anxiety they felt on a scale

  2 minutes before the intervention. Preoperative.

• Preoperative Stress Level-1

  This wearable device (smart bracelet) was used to evaluate the stress levels and heart rates of patients. It utilizes a built-in sensor to estimate users' stress levels, providing a score ranging from 1 to 100, where 1 indicates minimal stress and 100 represents very high stress. This estimation is derived from Heart Rate Variability (HRV) data. The device applies a proprietary algorithm-referred to as a stress model-to interpret HRV fluctuations and classify the user's stress level accordingly. The stress levels of a total of 96 patients were measured objectively with a smart bracelet.

  2 minutes before the intervention. Preoperative.

• Preoperative Heart Rate

  This wearable device was used to evaluate the stress levels and heart rates of patients. It utilizes a built-in sensor to estimate users' stress levels, providing a score ranging from 1 to 100, where 1 indicates minimal stress and 100 represents very high stress. This estimation is derived from Heart Rate Variability (HRV) data. The device applies a proprietary algorithm-referred to as a stress model-to interpret HRV fluctuations and classify the user's stress level accordingly. The heart rate levels of a total of 96 patients were measured objectively with a smart bracelet.

  2 minutes before the intervention. Preoperative.

Secondary Outcomes (3)

• Preoperative Anxiety Level-2

  Preoperative. immediately after intervention.

• Preoperative Stress Level

  Preoperative. immediately after intervention.

• Preoperative Heart Rate

  Preoperative. immediately after intervention.

Study Arms (3)

Virtual Reality Glasses Group

EXPERIMENTAL

The intervention group will watch a virtual reality video with mobile virtual glasses by the researcher (SŞ) and the stress level on the smart wristband will be recorded. In addition, necessary variables will be recorded with the data collection form.

Behavioral: Watching video with virtual glasses

Non-Virtual Reality Glasses Group

PLACEBO COMPARATOR

The plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded. In addition, necessary variables will be recorded with the data collection form.

Behavioral: watching video without virtual glasses

Control Group

NO INTERVENTION

Anxiety control will be done by the researcher (SU) for the control group.

Interventions

watching video without virtual glasses BEHAVIORAL

The plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded.

Non-Virtual Reality Glasses Group

Watching video with virtual glasses BEHAVIORAL

Using Mobile Virtual Glasses; In the preoperative period, after the patient is taken to the surgical service, a virtual reality video will be watched with mobile virtual glasses at the specified time (before going to the operating room on the day of surgery). Measurements will be made before and after the application. Necessary hygiene will be provided before the use of glasses, and the researcher will ensure hand cleaning before entering the patient's room.

Virtual Reality Glasses Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective abdominal surgery (e.g., appendectomy, ileal/bowel surgery, hernia repair, gallbladder/pancreas surgery)
• Awaiting transfer to the operating room on the morning of surgery
• Able to communicate effectively
• Able to provide informed consent

You may not qualify if:

• Patients undergoing unplanned or emergency surgery
• Patients in isolation
• Patients with visual and/or auditory impairments
• Patients with neurological conditions such as vertigo

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Hospital

Edirne, 22000, Turkey (Türkiye)

Location

Related Publications (5)

• Herrera-Espineira C, Rodriguez del Aguila Mdel M, Rodriguez del Castillo M, Valdivia AF, Sanchez IR. Relationship between anxiety level of patients and their satisfaction with different aspects of healthcare. Health Policy. 2009 Jan;89(1):37-45. doi: 10.1016/j.healthpol.2008.04.012. Epub 2008 Jun 11.

  PMID: 18550203 BACKGROUND

• Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Br J Anaesth. 2010 Mar;104(3):369-74. doi: 10.1093/bja/aeq002. Epub 2010 Feb 1.

  PMID: 20124283 BACKGROUND

• Lin LY, Wang RH. Abdominal surgery, pain and anxiety: preoperative nursing intervention. J Adv Nurs. 2005 Aug;51(3):252-60. doi: 10.1111/j.1365-2648.2005.03502.x.

  PMID: 16033593 BACKGROUND

• Hendricks TM, Gutierrez CN, Stulak JM, Dearani JA, Miller JD. The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. Mayo Clin Proc. 2020 Jun;95(6):1148-1157. doi: 10.1016/j.mayocp.2020.02.032.

  PMID: 32498771 BACKGROUND

• Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.

  PMID: 19377147 BACKGROUND

Related Links

• video that participants will watch with mobile virtual glasses - also video that participants will watch without virtual glasses

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Dogan Albayrak, Dr

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The evaluation process consisted of two stages: the first evaluation conducted in the morning and the second evaluation performed immediately before the patients were transferred to the operating room. To maintain blinding during the data collection, the patient information, anxiety and stress levels of the patients were evaluated by three senior nursing student researchers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This research was designed using the experimental (intervention) research method. Under the same environment and conditions, to determine the effect on the same dependent variable, the intervention (experimental) group using virtual reality and the placebo group not using virtual reality (watching the same video with the naked eye), pre-test (measurement of the dependent variable before the intervention), post-test (dependent measurement of the variable after intervention). In addition, the group that was not interfered with will form the control group and a data collection form will be applied with an interval of 30 minutes.

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: January 30, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after publication
• Access Criteria: The primary author is reached via e-mail and if requested, data will be shared with the consent of all authors.

Locations

TU (1)