AnxietyNCT07878039
Effects of Preoperative Virtual Reality on Surgical Fear and Anxiety in Patients
A study testing Virtual Reality (VR) Distraction in people with Anxiety and Surgical Fear, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Surgical Fear, Surgical Fear Scale
- What is being tested?
- Virtual Reality (VR) Distraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 15 Mar 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Able to communicate verbally
- Scheduled to undergo orthopedic surgery
- Willing to participate in the study
Who cannot join
- Visual or hearing impairment that may interfere with the virtual reality intervention
- History of a neurological disorder, such as migraine or epilepsy
- Diagnosed psychiatric disorder
- Head or neck condition that prevents the use of a virtual reality headset
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabük Training and Research Hospital
Karabük, Centre, 78000
About this study
Official title: Effects of Preoperative Virtual Reality on Surgical Fear and Anxiety in Patients Undergoing Orthopedic Surgery
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.
Read the detailed description
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.
- Conditions
- Anxiety, Surgical Fear, Surgical Fear Scale
- Being tested
- Virtual Reality (VR) Distraction
- Keywords
- Anxiety,, Surgical Fear, preoperative care, orthopedic surgery, virtual reality
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) DistractionDevice
Patients viewed immersive 360-degree nature and underwater relaxation videos using head-mounted virtual reality goggles during the preoperative period prior to orthopedic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Patients in this group received standard preoperative care and watched immersive nature and underwater videos using virtual reality goggles before orthopedic surgery. Receives: Device: Virtual Reality (VR) Distraction |
| Control Group | No intervention | Patients in this group received routine institutional preoperative nursing care and clinical support alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (upon hospital admission and before the intervention) and immediately before surgery (after the intervention and before transfer to the operating room).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start10 Jun 2024
- Primary completion12 Dec 2024
- Study completion15 Mar 2025
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 AnxietyStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: Patients allocated to the VR group received standard preoperative nursing care along with an immersive VR session delivered prior to surgery. Participants wore head-mounted VR goggles to view calming, high-definition 360-degree nature and underwater videos. Control Group: Patients allocated to the control group received standard institutional preoperative nursing care and routine clinical support alone.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RABİA GÖRÜCÜ, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878039
- Sponsor's protocol ID
- E-77192459-050.99-332158
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Yang JH, Ryu JJ, Nam E, Lee HS, Lee JK. Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. Arthroscopy. 2019 Aug;35(8):2394-2399. doi: 10.1016/j.arthro.2019.02.037.
PubMed 31395176
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Virtual Reality on Surgical Fear and Anxiety in Patients Undergoing Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07878039
- Acronym / sponsor ID
- E-77192459-050.99-332158
- Conditions
- Anxiety, Surgical Fear, Surgical Fear Scale
- Keywords
- Anxiety,, Surgical Fear, preoperative care, orthopedic surgery, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 16 Oct 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention Group: Patients allocated to the VR group received standard preoperative nursing care along with an immersive VR session delivered prior to surgery. Participants wore head-mounted VR goggles to view calming, high-definition 360-degree nature and underwater videos. Control Group: Patients allocated to the control group received standard institutional preoperative nursing care and routine clinical support alone.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual Reality (VR) DistractionPatients in this group received standard preoperative care and watched immersive nature and underwater videos using virtual reality goggles before orthopedic surgery. |
| Control Group | No intervention | –Patients in this group received routine institutional preoperative nursing care and clinical support alone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 65 years
- Able to communicate verbally
- Scheduled to undergo orthopedic surgery
- Willing to participate in the study
Key exclusion criteria (4 listed)
- Visual or hearing impairment that may interfere with the virtual reality intervention
- History of a neurological disorder, such as migraine or epilepsy
- Diagnosed psychiatric disorder
- Head or neck condition that prevents the use of a virtual reality headset
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 |
|---|---|---|
| Virtual Reality (VR) DistractionPatients viewed immersive 360-degree nature and underwater relaxation videos using head-mounted virtual reality goggles during the preoperative period prior to orthopedic surgery. | Device | Virtual Reality Group |
Primary outcome
Change in Preoperative Surgical Fear Assessed Using the Surgical Fear Questionnaire
Time frame: Baseline (upon hospital admission and before the intervention) and immediately before surgery (after the intervention and before transfer to the operating room).
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.
Change in Preoperative State Anxiety Assessed Using the State-Trait Anxiety Inventory-State Scale
Time frame: Baseline (upon hospital admission and before the intervention) and immediately before surgery (after the intervention and before transfer to the operating room).
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.
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 22 Oct 2026.
- Background: PubMed 31395176Yang JH, Ryu JJ, Nam E, Lee HS, Lee JK. Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. Arthroscopy. 2019 Aug;35(8):2394-2399. doi: 10.1016/j.arthro.2019.02.037.
- Individual participant dataSharing planned: 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.
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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 Virtual Reality (VR) Distraction in people with Anxiety and Surgical Fear, run by Karabuk 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 4 inclusion and 4 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 22 Oct 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?
Change in Preoperative Surgical Fear Assessed Using the Surgical Fear Questionnaire (time frame: Baseline (upon hospital admission and before the intervention) and immediately before surgery (after the intervention and before transfer to the operating room).). 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 NCT07878039, 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 22 Oct 2026.