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

Virtual Reality Clinical Trial

Official title:

The Effect of the Use of Virtual Reality Glasses on Surgical Fear and Anxiety in Patients Before Open Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165861
• Other study ID #: 2021-GOBAEK-452
• Status: Completed
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: October 16, 2023

Study information

• Verified date: December 2023
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. 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.

Before the surgery, study group patients will be asked to watch videos using virtual reality glasses.

Description:

The group distribution of the patients was made using the Random Allocation Software (Version 2.0.0) program and the patients were divided into two groups: the study group and the control group.

Patients in the study group were asked to watch videos using virtual reality glasses between the first, second and third evaluation before surgery.

The researcher visited the patients in the cardiovascular surgery ward before the surgery and reported that the patients in the study group would watch video (including nature sounds such as bird sounds, water sounds, etc) with virtual reality glasses. Patients in the control group were informed that the normal service protocol would be applied.

The Surgical Fear Scale was developed to measure the surgical fear levels experienced by patients before surgery. 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'. Visual Analog Scale - To evaluate anxiety, patients are asked to mark the anxiety they perceive on a line ranging from 0 -'no anxiety' to 10 -'highest level of anxiety'. The total score of the surgical fear scale is obtained by summing the scores of all scale questions; The lowest score that can be obtained is 0 and the highest score is 80. A lower score indicates that patients experience less surgical fear during their activities. Higher scores indicate a higher level of surgical fear.

To perform the first evaluation in the study group, the researcher went to the patient and evaluated the patient introduction form and surgical fear and anxiety levels. Then, the researcher nurse explained that they were waiting for the operating room team to arrive and gave the patients brief information about the virtual reality glasses. Then, entrances and exits to the room were restricted to ensure that the room was quiet enough to watch videos and away from distracting elements. Patients were then asked to watch the video carefully and focus on the video sounds. Virtual reality glasses were fitted to the patients and videos were started to be watched. The nurse researcher remained in the patient's room until the video ended. At the end of the video, the glasses were taken from the patient and disinfected, and the researcher nurse left the patient room. Then, a second evaluation was made by the service nurse. The third evaluation was made by the researcher nurse when the patients were taken down to the operating room waiting room.

In the control group, the first evaluation was made by the researcher nurse. Then, normal service protocol was applied to the control group patients and a second evaluation was made by the service nurse before going down to the operating room waiting room. The third evaluation was made by the researcher nurse in the operating room waiting room.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Fear
• Nurse
• Open Heart Surgery
• Preoperative Anxiety
• Virtual Reality

Intervention

Other:
• Experimental (with VR-G)
Watching video with using VR-G before undergoing open heart surgery

Locations

Country	Name	City	State
Turkey	Seher Ünver	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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