Open Heart SurgeryNCT06165861
The Effect of Using Virtual Reality Glasses on Surgical Fear and Anxiety
A study testing Experimental (with VR-G) in people with Open Heart Surgery and Virtual Reality, run by Trakya University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Open Heart Surgery, Virtual Reality, Preoperative Anxiety
- What is being tested?
- Experimental (with VR-G)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2022to 16 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Use of Virtual Reality Glasses on Surgical Fear and Anxiety in Patients Before Open Heart Surgery
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:
- 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.
- 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.
Read the 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.
- Conditions
- Open Heart Surgery, Virtual Reality, Preoperative Anxiety, Fear, Nurse
- Being tested
- Experimental (with VR-G)
- Keywords
- open heart surgery, virtual reality, preoperative anxiety, surgical fear, surgery nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (with VR-G)Other
Watching video with using VR-G before undergoing open heart surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.]
- 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".
Measured: 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.]
- 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".
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start14 Feb 2022
- Primary completion16 Jun 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Ünver, Trakya University
- Investigators
- Seher Ünver, Principal investigator, Trakya UniversityTuba Erol Akar, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165861
- Sponsor's protocol ID
- 2021-GOBAEK-452
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39614857
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of Virtual Reality Glasses on Surgical Fear and Anxiety in Patients Before Open Heart Surgery
- ClinicalTrials.gov ID
- NCT06165861
- Acronym / sponsor ID
- 2021-GOBAEK-452
- Conditions
- Open Heart Surgery, Virtual Reality, Preoperative Anxiety, Fear, Nurse
- Keywords
- open heart surgery, virtual reality, preoperative anxiety, surgical fear, surgery nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental (with VR-G) | Experimental | Other: Experimental (with VR-G)The patients in this procedure watched video with using VR-G for approximately 6 minutes at the surgical clinic before going surgery. |
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Volunteering to participate in the research,
- Will undergo open surgery,
- Will undergo planned surgical intervention,
- Being over 18 years of age,
- No visual impairment,
Key exclusion criteria (6 listed)
- Having an emergency surgical procedure
- Having a visual impairment
- Having a hearing impairment
- Being under 18 years of age
- Lack of mental health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental (with VR-G)Watching video with using VR-G before undergoing open heart surgery | Other | Experimental (with VR-G) |
Primary outcome
Surgical Fear
Time frame: one day
• 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".
Surgical Anxiety
Time frame: one day
• 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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 39614857Erol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seher Ünver principal investigator
Trakya University
Tuba Erol Akar principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental (with VR-G) in people with Open Heart Surgery and Virtual Reality, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Fear (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06165861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.