An interventional study of Experimental Group in Virtual Reality, Surgical Fear Scale and Anxiety, sponsored by Firat University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Firat University · Not applicable, Interventional, and Prevention
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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.
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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Firat University is the lead sponsor of 118 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Experimental Group
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.
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.
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.
Time frame: 40 minutes
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.
Time frame: 40 minutes
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in Jun 2026, 15 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 15 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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