Virtual RealityNCT07774156
Effect of a Single Immersive Virtual Reality Session on Preoperative Surgical Fear and State Anxiety
A study testing Experimental Group in people with Virtual Reality and Surgical Fear Scale, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
To determine whether a single 20-minute immersive VR nature session delivered in the immediate preoperative period reduces surgical fear and state anxiety in patients scheduled for bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Virtual Reality, Surgical Fear Scale, Anxiety
- What is being tested?
- Experimental Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 10 Jul 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 years or older
- scheduled for elective bariatric surgery
- able to communicate verbally
- without visual or hearing impairment
- without a diagnosed psychiatric disorder
- not concurrently using any other non-pharmacological anxiety-reduction method
Who cannot join
- younger than 18 years
- those with visual or hearing impairment
- those using another non-pharmacological method during the study period were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Single Immersive Virtual Reality Session on Preoperative Surgical Fear and State Anxiety in Patients Awaiting Bariatric Surgery
To determine whether a single 20-minute immersive VR nature session delivered in the immediate preoperative period reduces surgical fear and state anxiety in patients scheduled for bariatric surgery.
Read the detailed description
Patients awaiting bariatric surgery face permanent anatomical change, lifelong behavioural adaptation and uncertainty about weight-loss maintenance, and consequently report high levels of surgical fear and state anxiety. Immersive virtual reality (VR) is a low-cost, nurse-deliverable, non-pharmacological option, but its effect on surgical fear specifically, and in bariatric candidates in particular, is largely untested. To determine whether a single 20-minute immersive VR nature session delivered in the immediate preoperative period reduces surgical fear and state anxiety in patients scheduled for bariatric surgery.
A single-centre, two-arm, parallel-group randomised controlled trial was conducted in a general surgery clinic between March 2025 and June 2026 and is reported in accordance with the CONSORT 2025 statement. One hundred and twenty adults scheduled for bariatric surgery were randomly allocated 1:1 to a VR arm or to routine care. Two hours before transfer to theatre, the VR arm viewed 360° nature footage through a head-mounted display for 20 minutes; the control arm received the standard clinical protocol. Surgical fear (Surgical Fear Questionnaire, SFQ) and state anxiety (State Anxiety Inventory, STAI-S) were measured before and after the intervention period in both arms. The pre-specified primary analysis was an analysis of covariance of post-test scores adjusted for baseline, supported by mixed analysis of variance, change-score analysis, multivariable linear regression, non-parametric and rank-based sensitivity analyses, and the Reliable Change Index.
- Conditions
- Virtual Reality, Surgical Fear Scale, Anxiety
- Being tested
- Experimental Group
- Keywords
- Bariatric Surgery, Obesity, Preoperative Anxiety, Surgical Fear, Virtual Reality, Perioperative Nursing
- Medical subject headings
- Anxiety Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupBehavioural
Patients viewed 360° nature footage of forest, sea and landscape scenes, selected to be relaxing and to contain no threatening or surgery-related content and accessed through a publicly available video platform. The session lasted 20 minutes and was delivered by the researcher in the patient's own room, from which noise and interruptions were excluded. A duration of 20 minutes was chosen because relaxation-focused VR sessions of roughly 15 to 40 minutes are those most commonly reported to be effective and well tolerated, whereas longer exposures increase the risk of cybersickness . Post-test measures were administered 10 minutes after the session ended. Among the 60 patients who received the intervention, no adverse effects such as nausea, dizziness or disorientation were reported and no session was interrupted.
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | Patients viewed 360° nature footage of forest, sea and landscape scenes, selected to be relaxing and to contain no threatening or surgery-related content and accessed through a publicly available video platform. The session lasted 20 minutes and was delivered by the researcher in the patient's own room, from which noise and interruptions were excluded. A duration of 20 minutes was chosen because relaxation-focused VR sessions of roughly 15 to 40 minutes are those most commonly reported to be effective and well tolerated, whereas longer exposures increase the risk of cybersickness. Post-test measures were administered 10 minutes after the session ended. Among the 60 patients who received the intervention, no adverse effects such as nausea, dizziness or disorientation were reported and no session was interrupted. Receives: Behavioral: Experimental Group |
| Control group | No intervention | Patients allocated to the control arm received the standard clinical protocol of the unit with no additional intervention. Pre-test measures were administered two hours before transfer to theatre and post-test measures approximately 30 minutes later, so that the interval between assessments matched that in the VR arm. The comparator was therefore routine care rather than an attention-matched control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Fear Questionnaire (SFQ)
Developed by Theunissen et al. to quantify fear in patients awaiting elective surgery and adapted into Turkish by Bağdigen and Karaman Özlü . Eight items are rated on an 11-point numeric rating scale anchored at 0 (not afraid at all) and 10 (very afraid). Items 1-4 form the short-term fear subscale and items 5-8 the long-term fear subscale; each subscale ranges from 0 to 40 and the total from 0 to 80, with higher scores indicating greater fear. Cronbach's α was 0.93 in the original validation study.
Measured: 40 minutes
Secondary outcomes (1)
State Anxiety Inventory (STAI-S)
Developed by Spielberger et al. and adapted into Turkish by Öner and Le Compte . Twenty items are rated from 1 to 4, of which 10 are reverse-worded. The total is obtained by subtracting the sum of the reverse-worded items from the sum of the directly worded items and adding a constant of 50, giving a range of 20 to 80, with higher scores indicating greater state anxiety. Cronbach's α was 0.83 in the adaptation study.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start10 Mar 2025
- Primary completion10 Jun 2026
- Study completion10 Jul 2026
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 Virtual RealityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Güneş, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774156
- Sponsor's protocol ID
- Dilek
- Status last verified
- Jul 2026
- First submitted
- 15 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunes D, Acar O. Effect of a Single Immersive Virtual Nature Session on Preoperative Surgical Fear and State Anxiety in Patients Awaiting a Laparoscopic Sleeve Gastrectomy: A Randomised Controlled Trial. Healthcare (Basel). 2026 Sep 17;14(18):3067. doi: 10.3390/healthcare14183067.
PubMed 42793605
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Immersive Virtual Reality Session on Preoperative Surgical Fear and State Anxiety in Patients Awaiting Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07774156
- Acronym / sponsor ID
- Dilek
- Conditions
- Virtual Reality, Surgical Fear Scale, Anxiety
- Keywords
- Bariatric Surgery, Obesity, Preoperative Anxiety, Surgical Fear, Virtual Reality, Perioperative Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 19 Aug 2026 (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.
To determine whether a single 20-minute immersive VR nature session delivered in the immediate preoperative period reduces surgical fear and state anxiety in patients scheduled for bariatric surgery.
Detailed description
Patients awaiting bariatric surgery face permanent anatomical change, lifelong behavioural adaptation and uncertainty about weight-loss maintenance, and consequently report high levels of surgical fear and state anxiety. Immersive virtual reality (VR) is a low-cost, nurse-deliverable, non-pharmacological option, but its effect on surgical fear specifically, and in bariatric candidates in particular, is largely untested. To determine whether a single 20-minute immersive VR nature session delivered in the immediate preoperative period reduces surgical fear and state anxiety in patients scheduled for bariatric surgery.
A single-centre, two-arm, parallel-group randomised controlled trial was conducted in a general surgery clinic between March 2025 and June 2026 and is reported in accordance with the CONSORT 2025 statement. One hundred and twenty adults scheduled for bariatric surgery were randomly allocated 1:1 to a VR arm or to routine care. Two hours before transfer to theatre, the VR arm viewed 360° nature footage through a head-mounted display for 20 minutes; the control arm received the standard clinical protocol. Surgical fear (Surgical Fear Questionnaire, SFQ) and state anxiety (State Anxiety Inventory, STAI-S) were measured before and after the intervention period in both arms. The pre-specified primary analysis was an analysis of covariance of post-test scores adjusted for baseline, supported by mixed analysis of variance, change-score analysis, multivariable linear regression, non-parametric and rank-based sensitivity analyses, and the Reliable Change Index.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallel-group randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Behavioral: Experimental GroupPatients viewed 360° nature footage of forest, sea and landscape scenes, selected to be relaxing and to contain no threatening or surgery-related content and accessed through a publicly available video platform. The session lasted 20 minutes and was delivered by the researcher in the patient's own room, from which noise and interruptions were excluded. A duration of 20 minutes was chosen because relaxation-focused VR sessions of roughly 15 to 40 minutes are those most commonly reported to be effective and well tolerated, whereas longer exposures increase the risk of cybersickness. Post-test measures were administered 10 minutes after the session ended. Among the 60 patients who received the intervention, no adverse effects such as nausea, dizziness or disorientation were reported and no session was interrupted. |
| Control group | No intervention | –Patients allocated to the control arm received the standard clinical protocol of the unit with no additional intervention. Pre-test measures were administered two hours before transfer to theatre and post-test measures approximately 30 minutes later, so that the interval between assessments matched that in the VR arm. The comparator was therefore routine care rather than an attention-matched control. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 years or older
- scheduled for elective bariatric surgery
- able to communicate verbally
- without visual or hearing impairment
- without a diagnosed psychiatric disorder
Key exclusion criteria (3 listed)
- younger than 18 years
- those with visual or hearing impairment
- those using another non-pharmacological method during the study period were excluded
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 GroupPatients viewed 360° nature footage of forest, sea and landscape scenes, selected to be relaxing and to contain no threatening or surgery-related content and accessed through a publicly available video platform. The session lasted 20 minutes and was delivered by the researcher in the patient's own room, from which noise and interruptions were excluded. A duration of 20 minutes was chosen because relaxation-focused VR sessions of roughly 15 to 40 minutes are those most commonly reported to be effective and well tolerated, whereas longer exposures increase the risk of cybersickness . Post-test measures were administered 10 minutes after the session ended. Among the 60 patients who received the intervention, no adverse effects such as nausea, dizziness or disorientation were reported and no session was interrupted. | Behavioural | VR group |
Primary outcome
Surgical Fear Questionnaire (SFQ)
Time frame: 40 minutes
Developed by Theunissen et al. to quantify fear in patients awaiting elective surgery and adapted into Turkish by Bağdigen and Karaman Özlü . Eight items are rated on an 11-point numeric rating scale anchored at 0 (not afraid at all) and 10 (very afraid). Items 1-4 form the short-term fear subscale and items 5-8 the long-term fear subscale; each subscale ranges from 0 to 40 and the total from 0 to 80, with higher scores indicating greater fear. Cronbach's α was 0.93 in the original validation study.
1 secondary outcome
State Anxiety Inventory (STAI-S)
Time frame: 40 minutes
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 20 Aug 2026.
- Derived from this study: PubMed 42793605Gunes D, Acar O. Effect of a Single Immersive Virtual Nature Session on Preoperative Surgical Fear and State Anxiety in Patients Awaiting a Laparoscopic Sleeve Gastrectomy: A Randomised Controlled Trial. Healthcare (Basel). 2026 Sep 17;14(18):3067. doi: 10.3390/healthcare14183067.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Group in people with Virtual Reality and Surgical Fear Scale, run by Firat 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 6 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: finished, as of the sponsor's last update on 20 Aug 2026. 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 Questionnaire (SFQ) (time frame: 40 minutes). 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 NCT07774156, 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 20 Aug 2026.