The Effect of Using Virtual Reality Glasses on Surgical Fear and Anxiety

NCT06165861 | Completed DMC

• 1 other identifier: 2021-GOBAEK-452
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to evaluate the effect of using virtual reality glasses on the surgical fear and anxiety levels of patients undergoing open heart surgery on the morning of surgery. The main hypotheses are:

1. 1.The surgical fear level of patients who use virtual reality glasses on the morning of surgery is lower than patients who do not use virtual reality glasses.
2. 2.The anxiety level of patients who use virtual reality glasses on the morning of surgery is lower than patients who do not use virtual reality glasses.

Conditions

Open Heart Surgery; Virtual Reality; Preoperative Anxiety; Fear; Nurse

Keywords

open heart surgery; virtual reality; preoperative anxiety; surgical fear; surgery nurse

Outcome Measures

Primary Outcomes (2)

• Surgical Fear

  • Surgical fear level \[Time Frame: Measurements will start in the surgical ward in the morning of the surgery day before gowning the surgery clothes (such as surgical gown, caps) and will end in the waiting room before transferring to the operating room.\] o It will be evaluated using the Surgical Fear Scale. To assess surgical fear, patients are asked to rate their fear level for each question with a number ranging from 0 - "I am not afraid at all" to 10 - "I am very afraid".

  one day

• Surgical Anxiety

  • Anxiety level \[Time Frame: Measurements will start in the surgical ward in the morning of the surgery day before gowning the surgery clothes (such as surgical gown, caps) and will end in the waiting room before transferring to the operating room.\] o It will be evaluated using the Visual Analog Scale-Anxiety Scale. To assess anxiety, patients are asked to mark their perceived anxiety level on a horizontal line ranging from 0 - "no anxiety" to 10 - "highest anxiety level".

  one day

Study Arms (2)

Experimental (with VR-G)

EXPERIMENTAL

The patients in this procedure watched video with using VR-G for approximately 6 minutes at the surgical clinic before going surgery.

Other: Experimental (with VR-G)

Standard (No VR-G)

NO INTERVENTION

The patients took the standart protocol of the surgical clinic and didn't watch video with using VR-G

Interventions

Experimental (with VR-G) OTHER

Watching video with using VR-G before undergoing open heart surgery

Experimental (with VR-G)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the research,
• Will undergo open surgery,
• Will undergo planned surgical intervention,
• Being over 18 years of age,
• No visual impairment,
• No hearing impairment,
• No speech impediment,
• Lack of a psychiatric diagnosis was included.

You may not qualify if:

• Having an emergency surgical procedure
• Having a visual impairment
• Having a hearing impairment
• Being under 18 years of age
• Lack of mental health
• Having a speech impediment

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Seher Ünver

Edirne, 22030, Turkey (Türkiye)

Location

Related Publications (1)

• Erol Akar T, Unver S. Effectiveness of Virtual Reality Glasses on Surgical Fear and Anxiety in Patients Before Open-heart Surgery: A Double-blind Randomized Controlled Trial. J Perianesth Nurs. 2025 Jun;40(3):682-688. doi: 10.1016/j.jopan.2024.08.011. Epub 2024 Nov 30.

  PMID: 39614857 DERIVED

Study Officials

• Seher Ünver

  Trakya University

  PRINCIPAL INVESTIGATOR

• Tuba Erol Akar

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data analyse is going to be completed by a independent researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The research will be conducted using randomized controlled, experimental type and single-blind research methods. For this purpose, after the data are collected, they will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. Randomization method will be used to determine the groups. For this, the patients who meet the study criteria and volunteer will be assigned to the groups using the randomization program 'Random Allocation Software 2.0' according to the order of hospitalization.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 12, 2023
• Study Start: February 14, 2022
• Primary Completion: June 16, 2023
• Study Completion: October 16, 2023
• Last Updated: April 11, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)