An interventional study of Virtual Reality (VR) Distraction in Anxiety, Surgical Fear and Surgical Fear Scale, sponsored by Karabuk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Karabuk University · Not applicable, Interventional, and Supportive care
Preoperative fear and anxiety are common among patients undergoing orthopedic surgery and may adversely affect perioperative outcomes. This quasi-experimental study will aim to evaluate the effectiveness of preoperative virtual reality (VR) exposure in reducing surgical fear and anxiety among adult orthopedic patients.
A non-randomized controlled pretest-posttest study will be conducted with 74 adult patients undergoing orthopedic surgery. Participants will be assigned to either a VR intervention group (n=37) or a control group (n=37). Patients in the intervention group will receive immersive nature and underwater VR content in addition to standard preoperative care, whereas those in the control group will receive standard care alone. Surgical fear and anxiety will be assessed before and after the intervention using the Surgical Fear Questionnaire (SFQ) and the State-Trait Anxiety Inventory (STAI).
The study is expected to provide evidence regarding the feasibility and potential effectiveness of VR as a safe, non-pharmacological nursing intervention for reducing preoperative anxiety and surgical fear in orthopedic patients. The findings may guide the integration of VR into preoperative nursing care and inform future randomized controlled trials with larger samples.
Background and Rationale: Preoperative anxiety and surgical fear are important clinical concerns among adult patients scheduled for elective orthopedic surgery. These psychological responses may increase perioperative distress and postoperative pain and may negatively affect patients' recovery and overall surgical experience. Virtual reality (VR) provides an immersive, non-pharmacological distraction method that may reduce anxiety and fear by redirecting attention away from surgery-related stressors and promoting relaxation.
Study Aim: This study will aim to evaluate the effect of a preoperative VR intervention on surgical fear and anxiety among adult patients undergoing elective orthopedic surgery. The effects of VR combined with routine preoperative nursing care will be compared with those of routine care alone.
Study Design: The study will be conducted using a non-randomized controlled pretest-posttest quasi-experimental design. A total of 74 adult orthopedic surgical patients will be included. Participants will be assigned to either the VR intervention group (n=37) or the control group (n=37).
Study Procedures and Interventions:
Intervention Group: Patients assigned to the intervention group will receive routine preoperative nursing care in addition to the VR intervention. Participants will wear a head-mounted VR headset and view calming, high-definition 360-degree nature and underwater videos. The intervention will be administered in the orthopedic ward before surgery under the supervision of the researcher.
Control Group: Patients assigned to the control group will receive only the routine preoperative nursing care and clinical support provided by the institution. No additional non-pharmacological intervention will be applied.
Assessment Measures: Data will be collected at baseline and during the immediate preoperative period. Before the intervention, surgical fear and anxiety will be assessed in both groups. Post-intervention assessments will be conducted before the patients are transferred to the operating room.
The Surgical Fear Questionnaire (SFQ) will be used to assess short-term and long-term fears associated with surgery, anesthesia, postoperative recovery, and possible complications. The State-Trait Anxiety Inventory (STAI) will be used to assess patients' general tendency toward anxiety and their situational anxiety related to the upcoming surgical procedure.
Hypotheses: It is hypothesized that patients receiving the VR intervention will have lower post-intervention state anxiety and surgical fear scores than patients receiving routine preoperative care alone. It is also anticipated that the reductions in anxiety and surgical fear from baseline to the immediate preoperative period will be greater in the VR group.
Expected Contribution: The study is expected to provide evidence regarding the feasibility and potential effectiveness of immersive VR as a nurse-led, non-pharmacological intervention in preoperative orthopedic care. The findings may support the integration of digital distraction methods into preoperative nursing practices and guide future randomized controlled studies with larger samples.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 74 is close to the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Karabuk University is the lead sponsor of 131 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
Patients in this group received standard preoperative care and watched immersive nature and underwater videos using virtual reality goggles before orthopedic surgery.
Device: Virtual Reality (VR) Distraction
Patients in this group received routine institutional preoperative nursing care and clinical support alone.
Patients viewed immersive 360-degree nature and underwater relaxation videos using head-mounted virtual reality goggles during the preoperative period prior to orthopedic surgery.
Change in Preoperative Surgical Fear Assessed Using the Surgical Fear Questionnaire
Preoperative surgical fear will be assessed using the Surgical Fear Questionnaire (SFQ). The SFQ consists of eight items scored from 0 (not at all afraid) to 10 (very afraid). The total score ranges from 0 to 80 points. It includes two subscales: fear of the short-term consequences of surgery (items 1-4; score range: 0-40) and fear of the long-term consequences of surgery (items 5-8; score range: 0-40). Higher total and subscale scores indicate greater surgical fear and therefore a worse outcome. Change in surgical fear will be determined by comparing baseline and immediate preoperative scores.
Time frame: Baseline (upon hospital admission and before the intervention) and immediately before surgery (after the intervention and before transfer to the operating room).
Change in Preoperative State Anxiety Assessed Using the State-Trait Anxiety Inventory-State Scale
Preoperative state anxiety will be assessed using the State-Trait Anxiety Inventory-State Scale (STAI-S). The STAI-S consists of 20 items rated on a four-point scale. The total score ranges from 20 to 80 points. Higher scores indicate greater state anxiety and therefore a worse outcome. Change in state anxiety will be determined by comparing baseline and immediate preoperative scores.
Time frame: Baseline (upon hospital admission and before the intervention) and immediately before surgery (after the intervention and before transfer to the operating room).
Plan to share: No — Individual participant data (IPD) will not be shared to ensure participant privacy and confidentiality, as explicit consent for open data sharing was not obtained during the ethics approval process.
Ran from Jun 2024 to primary completion in Dec 2024, 6 months.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 6 months is below that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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