Clinical PracticeNCT06666465
The Effect of the Operating Room Environment on Patients Experienced With Virtual Reality Glasses Before Surgery
A study testing Operating Room Environment Experienced by Patients Wearing Virtual Reality Glasses Before Surgery The Effect of Surgery Experience on Surgical Fear Level and Care Perceptions in people with Clinical Practice and Virtual Reality, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a randomized controlled experimental study with a pretest-posttest design to examine the effect of the operating room environment experience of preoperative patients using virtual reality glasses on the patients' preoperative surgical fear level and care perceptions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clinical Practice, Virtual Reality, Nursing Care
- What is being tested?
- Operating Room Environment Experienced by Patients Wearing Virtual Reality Glasses Before Surgery The Effect of Surgery Experience on Surgical Fear Level and Care Perceptions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being 18 years or older
- Agreeing to participate in the research
- Having elective cholecystectomy surgery
- Knowledge of Turkish and no communication barriers
- Having surgery for the first time and not having seen the operating room environment
Who cannot join
- Being 18 years of age or younger
- Refusal to participate in the research
- Having undergone surgery and having seen the operating room environment before Not knowing Turkish and having any communication barrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İmren Erer
İnönü, Eskişehir, 26670
İmren Erer, 05462612180, mavilik_olsun@hotmail.com
emine arıcı parlak, 05073578357, emine.ariciparlak@sbu.edu.tr
About this study
Official title: Operating Room Environment Experienced by Patients With Virtual Reality Glasses Before Surgery The Effect of Surgical Experience on the Level of Surgical Fear and Perceptions of Care
This study was planned as a randomized controlled experimental study with a pretest-posttest design to examine the effect of the operating room environment experience of preoperative patients using virtual reality glasses on the patients' preoperative surgical fear level and care perceptions.
Read the detailed description
Today, virtual reality is used in many areas such as medical diagnosis and treatment by reflecting three-dimensional images animated on the computer as if it were a real experience. Procedural pain, facilitating interventional procedures with a game-based video demonstration in children, and outpatient surgeries such as circumcision surgery can be used to provide patients with this "real world" experience, its use has also become widespread in areas such as wound care and in nursing education due to the increase in malpractice cases . In line with patient experiences, the benefits of virtual reality technology have been documented in the literature and its use in nursing care is increasing . Informing the patient to improve the quality of care, managing pain during painful interventional procedures, and reducing surgery-related fear reduces wound healing and hospital stay, especially in surgical patients . In the literature, patients' pre-operative problems such as lack of knowledge about the surgery, operating room environment, surgical procedures, etc. It is reported that they experience anxiety and fear related to many factors. It also emphasizes the importance of informing the patient before surgery within the scope of Enhance Recovery After Surgery (ERAS) procedures (Joshi \& Kehlet, 2019). In line with ERAS protocols, preoperative education and information have been proven to provide positive postoperative recovery. Informing the patient about the operating room environment is the most important element in accelerating surgical recovery. The operating room environment can be seen as a stress factor for patients. Therefore, in this study, we aimed to examine the effect of informing patients about the operating room environment, supported by visuals, on the patient's fear and perceptions of care. In addition, it is thought that this information and experience will affect the patient's vital signs and that the patient's need for premedication will also change. It is thought that the results of this study will positively affect patient outcomes by improving the quality of patient care.
- Conditions
- Clinical Practice, Virtual Reality, Nursing Care, Simulation
- Being tested
- Operating Room Environment Experienced by Patients Wearing Virtual Reality Glasses Before Surgery The Effect of Surgery Experience on Surgical Fear Level and Care Perceptions
- Keywords
- Clinical practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operating Room Environment Experienced by Patients Wearing Virtual Reality Glasses Before Surgery The Effect of Surgery Experience on Surgical Fear Level and Care PerceptionsOther
The video, which will be shot for patients to experience the operating environment, will include premedication, an operating room and a post-operative care unit. In the video, the operating room environment will be recorded by the researcher with a voice introduction. The image was shot with a 360-degree camera (Insta 360 One X2), edited with an application program (Insta 360 Studio) and then uploaded to the YouTube VR Pro application as a secret video. The video will be shown to the glasses via an Android phone on the internet via YouTube. People wearing glasses at the screening will be able to look in any direction they want thanks to the 360-degree video. They will be able to watch the video again if they want.
| Study group | Role | What they receive |
|---|---|---|
| Operating Room Environment Experienced by Patients | Experimental | This study was planned as a randomized controlled experimental study in the pre-test post-test design in order to examine the effect of the operating room environment experience of patients using virtual reality glasses before surgery on the level of surgical fear experienced by patients before surgery and their perception of care. Receives: Other: Operating Room Environment Experienced by Patients Wearing Virtual Reality Glasses Before Surgery The Effect of Surgery Experience on Surgical Fear Level and Care Perceptions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in surgical fear levels of patients in the operating environment after simulation experience with virtual reality glasses
Change in Anxiety and Stress Levels during the care of patients undergoing surgery Simulation of the operating room environment to patients using virtual reality glasses will affect patients' stress and anxiety levels in the operating room. This situation will be evaluated. The scale consists of 8 items, scored from 0 to 10, and is an 11-point Likert-type scale. Each item is scored as 0 "not at all afraid" and 10 "very afraid". The scale consists of two sub-dimensions, each consisting of four items. These indicate the fear of short-term and long-term consequences of surgery; items 1-4 in the scale measure the fear of short-term consequences of surgery, while items 5-8 measure the fear of long-term consequences of surgery.
Measured: Preoperative Use of Virtual Reality After Simulation
change in patients' perceptions of nursing care
The change in patients' nursing care perception scores will be measured. There are 15 statements on the Likert-type scale regarding the quality of nursing care. It is requested to mark one of the 15 statements that make up the scale: I agree = 5, I somewhat agree = 4, I am undecided = 3, I disagree = 2, I strongly disagree = 1 and no response = 0. The score given for each item is taken as basis. Thus, a minimum of 15 and a maximum of 75 points can be obtained from the scale. The increase in the total score obtained from the scale indicates that the patient is satisfied with the nursing care.
Measured: Preoperative Use of Virtual Reality After Simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start15 Aug 2024
- Primary completion16 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
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 Clinical PracticeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Patients participating in the study will be included in a group by gender-based stratified block randomization method. Patients in the intervention group will experience the operating room environment with VR glasses (n: 30), while patients in the control group (n: 30) will receive standard nursing care.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İmren Erer, Saglik Bilimleri Universitesi
- Investigators
- Emine Parlak, 2, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666465
- Sponsor's protocol ID
- ierer
- Status last verified
- Mar 2025
- First submitted
- 23 Aug 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Addab, S., Hamdy, R., & Thorstad, K. (2022). Use of Virtual Reality in Managing Pediatric Prosedural Pain and Anxiety: an Integrative Literature Review. Journal of Clinical Nursing, 31(21-22), s. 3032-3059. Ahern, M., Dean, L., Stoddard, C., Agrawai, A., Kim, K., Cook, C., & Garcia, A. (2020). The Effectviveness of Virtual Reality in Patients with Spinal Pain: Systematic Review and Meta- Analysis. Pain Practice, 20(6), s. 656-675. Baytar, Ç., & Bollucuoğlu, K. (2021). Effect of Virtual Reality on Preoperative Anxiety Inpatients Undergoing septorhinoplasty. Brazilian Journal of Anesthesiology, 1(744276), s. 1-6. Bağdigen Kaya, M., & Karaman Özlü, Z. (2019). Elektif Cerrahi Bekleyen Hastalarda Cerrahi Korkunun Sosyal Destek Algısı ile İlişkisinin Belirlenmesi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 22(4), s. 281-290.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operating Room Environment Experienced by Patients With Virtual Reality Glasses Before Surgery The Effect of Surgical Experience on the Level of Surgical Fear and Perceptions of Care
- ClinicalTrials.gov ID
- NCT06666465
- Acronym / sponsor ID
- ierer
- Conditions
- Clinical Practice, Virtual Reality, Nursing Care, Simulation
- Keywords
- Clinical practice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 16 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 30 Oct 2024 (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.
This study was planned as a randomized controlled experimental study with a pretest-posttest design to examine the effect of the operating room environment experience of preoperative patients using virtual reality glasses on the patients' preoperative surgical fear level and care perceptions.
Detailed description
Today, virtual reality is used in many areas such as medical diagnosis and treatment by reflecting three-dimensional images animated on the computer as if it were a real experience. Procedural pain, facilitating interventional procedures with a game-based video demonstration in children, and outpatient surgeries such as circumcision surgery can be used to provide patients with this "real world" experience, its use has also become widespread in areas such as wound care and in nursing education due to the increase in malpractice cases . In line with patient experiences, the benefits of virtual reality technology have been documented in the literature and its use in nursing care is increasing . Informing the patient to improve the quality of care, managing pain during painful interventional procedures, and reducing surgery-related fear reduces wound healing and hospital stay, especially in surgical patients . In the literature, patients' pre-operative problems such as lack of knowledge about the surgery, operating room environment, surgical procedures, etc. It is reported that they experience anxiety and fear related to many factors. It also emphasizes the importance of informing the patient before surgery within the scope of Enhance Recovery After Surgery (ERAS) procedures (Joshi \& Kehlet, 2019). In line with ERAS protocols, preoperative education and information have been proven to provide positive postoperative recovery. Informing the patient about the operating room environment is the most important element in accelerating surgical recovery. The operating room environment can be seen as a stress factor for patients. Therefore, in this study, we aimed to examine the effect of informing patients about the operating room environment, supported by visuals, on the patient's fear and perceptions of care. In addition, it is thought that this information and experience will affect the patient's vital signs and that the patient's need for premedication will also change. It is thought that the results of this study will positively affect patient outcomes by improving the quality of patient care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients participating in the study will be included in a group by gender-based stratified block randomization method. Patients in the intervention group will experience the operating room environment with VR glasses (n: 30), while patients in the control group (n: 30) will receive standard nursing care.
| Arm | Type | Receives |
|---|---|---|
| Operating Room Environment Experienced by Patients | Experimental | Other: Operating Room Environment Experienced by Patients Wearing Virtual Reality Glasses Before Surgery The Effect of Surgery Experience on Surgical Fear Level and Care PerceptionsThis study was planned as a randomized controlled experimental study in the pre-test post-test design in order to examine the effect of the operating room environment experience of patients using virtual reality glasses before surgery on the level of surgical fear experienced by patients before surgery and their perception of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Being 18 years or older
- Agreeing to participate in the research
- Having elective cholecystectomy surgery
- Knowledge of Turkish and no communication barriers
- Having surgery for the first time and not having seen the operating room environment
Key exclusion criteria (3 listed)
- Being 18 years of age or younger
- Refusal to participate in the research
- Having undergone surgery and having seen the operating room environment before Not knowing Turkish and having any communication barrier
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 |
|---|---|---|
| Operating Room Environment Experienced by Patients Wearing Virtual Reality Glasses Before Surgery The Effect of Surgery Experience on Surgical Fear Level and Care PerceptionsThe video, which will be shot for patients to experience the operating environment, will include premedication, an operating room and a post-operative care unit. In the video, the operating room environment will be recorded by the researcher with a voice introduction. The image was shot with a 360-degree camera (Insta 360 One X2), edited with an application program (Insta 360 Studio) and then uploaded to the YouTube VR Pro application as a secret video. The video will be shown to the glasses via an Android phone on the internet via YouTube. People wearing glasses at the screening will be able to look in any direction they want thanks to the 360-degree video. They will be able to watch the video again if they want. | Other | Operating Room Environment Experienced by Patients |
Primary outcome
Change in surgical fear levels of patients in the operating environment after simulation experience with virtual reality glasses
Time frame: Preoperative Use of Virtual Reality After Simulation
Change in Anxiety and Stress Levels during the care of patients undergoing surgery Simulation of the operating room environment to patients using virtual reality glasses will affect patients' stress and anxiety levels in the operating room. This situation will be evaluated. The scale consists of 8 items, scored from 0 to 10, and is an 11-point Likert-type scale. Each item is scored as 0 "not at all afraid" and 10 "very afraid". The scale consists of two sub-dimensions, each consisting of four items. These indicate the fear of short-term and long-term consequences of surgery; items 1-4 in the scale measure the fear of short-term consequences of surgery, while items 5-8 measure the fear of long-term consequences of surgery.
change in patients' perceptions of nursing care
Time frame: Preoperative Use of Virtual Reality After Simulation
The change in patients' nursing care perception scores will be measured. There are 15 statements on the Likert-type scale regarding the quality of nursing care. It is requested to mark one of the 15 statements that make up the scale: I agree = 5, I somewhat agree = 4, I am undecided = 3, I disagree = 2, I strongly disagree = 1 and no response = 0. The score given for each item is taken as basis. Thus, a minimum of 15 and a maximum of 75 points can be obtained from the scale. The increase in the total score obtained from the scale indicates that the patient is satisfied with the nursing care.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- BackgroundAddab, S., Hamdy, R., & Thorstad, K. (2022). Use of Virtual Reality in Managing Pediatric Prosedural Pain and Anxiety: an Integrative Literature Review. Journal of Clinical Nursing, 31(21-22), s. 3032-3059. Ahern, M., Dean, L., Stoddard, C., Agrawai, A., Kim, K., Cook, C., & Garcia, A. (2020). The Effectviveness of Virtual Reality in Patients with Spinal Pain: Systematic Review and Meta- Analysis. Pain Practice, 20(6), s. 656-675. Baytar, Ç., & Bollucuoğlu, K. (2021). Effect of Virtual Reality on Preoperative Anxiety Inpatients Undergoing septorhinoplasty. Brazilian Journal of Anesthesiology, 1(744276), s. 1-6. Bağdigen Kaya, M., & Karaman Özlü, Z. (2019). Elektif Cerrahi Bekleyen Hastalarda Cerrahi Korkunun Sosyal Destek Algısı ile İlişkisinin Belirlenmesi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 22(4), s. 281-290.
- 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.
Emine Parlak, 2 study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operating Room Environment Experienced by Patients Wearing Virtual Reality Glasses Before Surgery The Effect of Surgery Experience on Surgical Fear Level and Care Perceptions in people with Clinical Practice and Virtual Reality, run by Saglik Bilimleri Universitesi 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İmren Erer (05462612180, mavilik_olsun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in surgical fear levels of patients in the operating environment after simulation experience with virtual reality glasses (time frame: Preoperative Use of Virtual Reality After Simulation). 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 NCT06666465, 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 24 Mar 2025.