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OpenTrials
Completed

NCT Number: NCT07774156

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.

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Key information

Conditions

Virtual Reality Anxiety Anxiety Disorders Body Weight Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgical Fear Scale

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Firat Universty

Elâzığ, 23119, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • younger than 18 years
  • those with visual or hearing impairment
  • those using another non-pharmacological method during the study period were excluded

Treatment and study plan

Experimental group

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. State Anxiety Inventory (STAI-S)

    Time frame: 40 minutes

    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.

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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