AnxietyNCT06936540
The Effect of Virtual Tour Training Before Orthopedic Surgery
A study testing Virtual Tour in people with Anxiety and Satisfaction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to determine the effect of training on surgical environments provided with virtual tour before orthopedic surgical ıntervention on patients' anxiety and satisfaction level. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Satisfaction
- What is being tested?
- Virtual Tour
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2025to 12 Oct 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
- Between the ages of 18-65
- Being literate
- No comprehension and perception problems
- No hearing and vision problems
- Not being under psychiatric treatment
- No surgical experience
- To undergo elective orthopedic surgery in the operating room
- Acceptance to participate in the research
Who cannot join
- To undergo emergency orthopedic surgery
- Wishing to leave at any stage of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa Institute of Graduate Studies
Istanbul
About this study
Official title: The Effect of Training on Surgical Environments Provided With Virtual Tour Before Orthopedic Surgical Intervention on Patients' Anxiety and Satisfaction Level
The purpose of the study is to determine the effect of training on surgical environments provided with virtual tour before orthopedic surgical ıntervention on patients' anxiety and satisfaction level.
Read the detailed description
Although preoperative anxiety is accepted as a normal patient response, severe anxiety can lead to a number of negative physiological, emotional and cognitive consequences for patients and ultimately to prolonged hospitalization. If anxiety is not managed effectively in the preoperative period, recovery time is prolonged and the risk of anesthesia and surgery-related complications increases. Moreover, it can lead to respiratory distress and cardiac problems. It causes life threats by increasing the risk of bleeding with deterioration in hemodynamic parameters and negatively affects surgical outcomes and patient satisfaction. For all these reasons, this study was designed to contribute to the management of anxiety, which is seen as a problem that needs to be addressed in surgical nursing.
- Conditions
- Anxiety, Satisfaction
- Being tested
- Virtual Tour, No Interventions
- Keywords
- Anxiety, Satisfaction, Virtual Reality, Orthopedic Surgical Procedures
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual TourOther
The intervention group will be trained by the researcher with a virtual tour material about surgical environments via a tablet computer.
No InterventionsOther
The control group will not receive any intervention other than verbal training in the routine of the organization.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | The intervention group will be trained by the researcher with a virtual tour material about surgical environments via a tablet computer. Receives: Other: Virtual Tour |
| Control group | Other | The control group will not receive any intervention other than verbal training in the routine of the organization. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI): Pre-test and post-test differences of anxiety levels
The State-Trait Anxiety Inventory (STAI) is accepted as the the gold standard to determine the level of anxiety. The validity and reliability of the STAI in Turkey was conducted by Oner and Le Compte. The STAI can be administered to individuals over the age of 14 and there is no time limit for answering. It includes two separate scales of twenty items each (ie, the State Anxiety Scale (STAI-S) and the Trait Anxiety Scale (STAI-T). STAI-S and STAI-T scores are calculated separately. The total score obtained from the scales varies between 20 and 80, and a high score indicates a high level of anxiety.
Measured: From immediately before preoperative training to immediately after preoperative training (on the day before surgery).
Secondary outcomes (1)
Visual Analog Scale (VAS) for Satisfaction: Pre-test and post-test differences of satisfaction levels
The satisfaction form, created by the researcher using the Visual Analog Scale (VAS), includes a scale for patients to rate their satisfaction. Scoring is between 0 and 10 points (0 to 10 inclusive). A high score indicates a high level of satisfaction.
Measured: From immediately before preoperative training to immediately after preoperative training (on the day before surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start12 Apr 2025
- Primary completion12 Oct 2025
- Study completion12 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as an open-label, randomized, controlled, parallel group interventional study. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will be trained by the researcher with a virtual tour material about surgical environments via a tablet computer. The control group will not receive any intervention other than verbal training in the routine of the organization.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Baydemir, Istanbul University - Cerrahpasa
- Investigators
- Seda Baydemir, PhD-candidate, Principal investigator, Istanbul University-Cerrahpasa Institute of Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936540
- Sponsor's protocol ID
- IUC-SN-SB-01
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training on Surgical Environments Provided With Virtual Tour Before Orthopedic Surgical Intervention on Patients' Anxiety and Satisfaction Level
- ClinicalTrials.gov ID
- NCT06936540
- Acronym / sponsor ID
- IUC-SN-SB-01
- Conditions
- Anxiety, Satisfaction
- Keywords
- Anxiety, Satisfaction, Virtual Reality, Orthopedic Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- 12 Oct 2025 (actual)
- Study completion
- 12 Oct 2025 (actual)
- First posted
- 20 Apr 2025 (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.
The purpose of the study is to determine the effect of training on surgical environments provided with virtual tour before orthopedic surgical ıntervention on patients' anxiety and satisfaction level.
Detailed description
Although preoperative anxiety is accepted as a normal patient response, severe anxiety can lead to a number of negative physiological, emotional and cognitive consequences for patients and ultimately to prolonged hospitalization. If anxiety is not managed effectively in the preoperative period, recovery time is prolonged and the risk of anesthesia and surgery-related complications increases. Moreover, it can lead to respiratory distress and cardiac problems. It causes life threats by increasing the risk of bleeding with deterioration in hemodynamic parameters and negatively affects surgical outcomes and patient satisfaction. For all these reasons, this study was designed to contribute to the management of anxiety, which is seen as a problem that needs to be addressed in surgical nursing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was planned as an open-label, randomized, controlled, parallel group interventional study. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will be trained by the researcher with a virtual tour material about surgical environments via a tablet computer. The control group will not receive any intervention other than verbal training in the routine of the organization.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Virtual TourThe intervention group will be trained by the researcher with a virtual tour material about surgical environments via a tablet computer. |
| Control group | Other | Other: No InterventionsThe control group will not receive any intervention other than verbal training in the routine of the organization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 18-65
- Being literate
- No comprehension and perception problems
- No hearing and vision problems
- Not being under psychiatric treatment
Key exclusion criteria (2 listed)
- To undergo emergency orthopedic surgery
- Wishing to leave at any stage of the study
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 TourThe intervention group will be trained by the researcher with a virtual tour material about surgical environments via a tablet computer. | Other | Intervention group |
| No InterventionsThe control group will not receive any intervention other than verbal training in the routine of the organization. | Other | Control group |
Primary outcome
State-Trait Anxiety Inventory (STAI): Pre-test and post-test differences of anxiety levels
Time frame: From immediately before preoperative training to immediately after preoperative training (on the day before surgery).
The State-Trait Anxiety Inventory (STAI) is accepted as the the gold standard to determine the level of anxiety. The validity and reliability of the STAI in Turkey was conducted by Oner and Le Compte. The STAI can be administered to individuals over the age of 14 and there is no time limit for answering. It includes two separate scales of twenty items each (ie, the State Anxiety Scale (STAI-S) and the Trait Anxiety Scale (STAI-T). STAI-S and STAI-T scores are calculated separately. The total score obtained from the scales varies between 20 and 80, and a high score indicates a high level of anxiety.
1 secondary outcome
Visual Analog Scale (VAS) for Satisfaction: Pre-test and post-test differences of satisfaction levels
Time frame: From immediately before preoperative training to immediately after preoperative training (on the day before surgery).
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 18 Nov 2025.
- 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.
Seda Baydemir, PhD-candidate principal investigator
Istanbul University-Cerrahpasa Institute of Graduate Studies
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 Tour in people with Anxiety and Satisfaction, run by Istanbul University - Cerrahpasa 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 8 inclusion and 2 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 18 Nov 2025. 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?
State-Trait Anxiety Inventory (STAI): Pre-test and post-test differences of anxiety levels (time frame: From immediately before preoperative training to immediately after preoperative training (on the day before surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.