Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-03 @ 8:20 PM
Study NCT ID:
NCT06165861
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2023-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Using Virtual Reality Glasses on Surgical Fear and Anxiety
Sponsor:
Trakya University
Organization:
Study Overview
Official Title:
The Effect of the Use of Virtual Reality Glasses on Surgical Fear and Anxiety in Patients Before Open Heart Surgery
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: