Clinical trial NCT06165861: The Effect of Using Virtual Reality Glasses on Surgical Fear and Anxiety
Official title: The Effect of the Use of Virtual Reality Glasses on Surgical Fear and Anxiety in Patients Before Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Heart Surgery
Virtual Reality
Preoperative Anxiety
Fear
Nurse
Keywords: open heart surgery
virtual reality
preoperative anxiety
surgical fear
surgery nurse
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical Fear
timeFrame: one day
measure: Surgical Anxiety
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Seher Ünver
Study officials:
affiliation: Trakya University
name: Seher Ünver
role: PRINCIPAL_INVESTIGATOR
affiliation: Trakya University
name: Tuba Erol Akar
role: PRINCIPAL_INVESTIGATOR
References: