Lumbar Disc HerniationNCT07443111
Comparison of Virtual Reality-Based and Routine Preoperative Education on Surgical Anxiety and Salivary Cortisol
A study testing Virtual Reality-Based Preoperative Education and Routine Preoperative Education in people with Lumbar Disc Herniation and Preoperative Anxiety, run by Bezmialem Vakif University.
Trial summary
This randomized controlled pilot study aims to compare the effects of virtual reality-based preoperative education and routine preoperative education on surgical anxiety in patients undergoing lumbar disc surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation, Preoperative Anxiety
- What is being tested?
- Virtual Reality-Based Preoperative Education and Routine Preoperative Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2026to 27 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 18 and 65 years
- Hospitalized patients scheduled for elective lumbar disc herniation surgery in the preoperative period
- American Society of Anesthesiologists (ASA) physical status I-III
- Able to read and understand Turkish and be literate
- Sufficient cognitive capacity to understand the informed consent form (no advanced dementia, severe aphasia, impaired consciousness, or neurological/psychiatric condition interfering with communication)
- Willing to complete the State Anxiety Inventory - State form (STAI-S) for surgical anxiety assessment and to provide a saliva sample using a non-invasive method
- No severe visual impairment that would prevent the use of a virtual reality headset (visual impairments correctable with glasses or contact lenses are acceptable)
- Provision of written and verbal informed consent
Who cannot join
- Presence of an emergency or urgent neurosurgical indication (e.g., traumatic acute subdural hematoma, acute intracranial hemorrhage with herniation signs)
- History of diagnosed epilepsy, particularly photosensitive epilepsy
- Severe cognitive impairment, severe aphasia, lack of cooperation, or altered level of consciousness
- History of psychiatric hospitalization within the last 6 months due to severe psychiatric disorders such as psychotic disorder, bipolar disorder, or severe major depressive disorder
- Chronic systemic steroid use or endocrine disorders significantly affecting adrenal cortex function (e.g., Cushing syndrome, Addison's disease)
- Untreated severe thyroid disease that may affect cortisol metabolism
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- History of severe vertigo or vestibular disorders with prior intolerance to VR-like visual stimuli
- Severe visual impairment not correctable with glasses or contact lenses that would prevent adequate perception of VR content
- Inability to complete the VR session due to nausea, dizziness, or similar symptoms during headset use (in such cases, the intervention will be discontinued and the participant will be withdrawn from the study)
- Severe oral lesions, active serious oral infection, or significant salivary gland pathology interfering with saliva sampling
- Known pregnancy or suspected pregnancy
- Participation in another randomized controlled trial or VR-based intervention within the last 3 months
- Withdrawal of consent during the study or cancellation/postponement of the scheduled surgical procedure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nurgül Arpag, Assistant Professor, PhD, RN contact
About this study
Official title: Comparative Evaluation of the Effect of Virtual Reality-Based Preoperative Education on Surgical Anxiety Using Psychometric Measures and Salivary Cortisol: A Randomized Controlled Pilot Trial
This randomized controlled pilot study aims to compare the effects of virtual reality-based preoperative education and routine preoperative education on surgical anxiety in patients undergoing lumbar disc surgery. In addition to evaluating psychological outcomes, the study will also compare psychometric anxiety assessments with a biological stress marker, salivary cortisol, to examine the relationship between subjective and physiological stress responses.
Preoperative anxiety is common among surgical patients and may negatively influence both emotional well-being and physiological stress regulation. Virtual reality-based education may provide a more immersive and engaging learning experience compared to routine education, potentially reducing anxiety levels.
Read more
Participants will be randomly assigned to either a virtual reality-based education group or a routine preoperative education group. Surgical anxiety will be assessed using validated psychometric measurement tools, and physiological stress response will be evaluated through salivary cortisol analysis. The study will further explore the concordance between psychometric findings and biological stress indicators.
The results may contribute to the development of innovative, evidence-based nursing interventions and provide insight into the relationship between psychological and biological indicators of preoperative anxiety.
Read the detailed description
This randomized controlled pilot trial is designed to evaluate the effectiveness of virtual reality-based preoperative education compared to routine preoperative education in adult patients scheduled for elective lumbar disc surgery. In addition to comparing anxiety levels between groups, the study aims to examine the relationship between psychometric assessments of surgical anxiety and the biological stress response measured by salivary cortisol.
Eligible participants will be adult patients undergoing elective lumbar disc surgery who meet the inclusion criteria and provide informed consent. Participants will be randomly allocated to one of two groups using a structured randomization process to ensure balanced distribution.
The intervention group will receive a structured virtual reality-based preoperative education session delivered through immersive technology explaining the surgical procedure, operating room environment, and perioperative process. The control group will receive routine preoperative education provided according to standard clinical practice. All participants will continue to receive standard medical and nursing care.
Data collection will be performed at predefined time points. Baseline measurements (T0) will be obtained prior to the educational intervention. Post-intervention anxiety assessments and salivary cortisol sampling (T1) will be conducted during the preoperative period before surgery. Surgical anxiety will be assessed using validated psychometric measurement instruments. Salivary cortisol levels will be analyzed as an objective indicator of physiological stress response.
The study will evaluate between-group differences in anxiety scores and cortisol levels. Additionally, the concordance and relationship between subjective psychometric measures and biological stress markers will be analyzed.
As a pilot study, the primary objectives include assessing feasibility, preliminary effectiveness, and methodological suitability for a future large-scale randomized trial. The findings may contribute to the development of evidence-based, technology-supported nursing interventions aimed at reducing preoperative anxiety and improving perioperative patient outcomes.
- Conditions
- Lumbar Disc Herniation, Preoperative Anxiety
- Being tested
- Virtual Reality-Based Preoperative Education, Routine Preoperative Education
- Keywords
- Virtual Reality, Lumbar Disc Herniation, Preoperative Anxiety, Salivary Cortisol, Randomized Controlled Trial, Nursing Intervention
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Preoperative EducationBehavioural
Virtual reality-based structured preoperative education delivered via a head-mounted VR device before lumbar disc surgery.
Routine Preoperative EducationBehavioural
Standard verbal preoperative education provided according to hospital clinical practice before lumbar disc surgery.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-Based Preoperative Education | Experimental | Participants in this arm receive virtual reality-based preoperative education using a head-mounted VR device on the day before lumbar disc surgery. The VR content provides structured information about the surgical process, operating room environment, anesthesia, and postoperative expectations. Psychological anxiety is assessed using validated psychometric scales, and salivary cortisol samples are collected to evaluate the physiological stress response. Receives: Behavioral: Virtual Reality-Based Preoperative Education |
| Routine Preoperative Education | Active comparator | Participants in this arm receive routine preoperative education provided according to the hospital's standard clinical practice before lumbar disc surgery. The education includes verbal information about the surgical procedure, anesthesia, and postoperative care. Psychological anxiety is assessed using validated psychometric scales, and salivary cortisol samples are collected to evaluate the physiological stress response. Receives: Behavioral: Routine Preoperative Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Surgical Anxiety Level (SAQ Total Score)
Change in preoperative anxiety measured by the Surgical Anxiety Questionnaire (SAQ) total score between baseline (T1, pre-intervention on the morning of surgery) and post-intervention assessment (T2, 90-120 minutes before surgery).
Measured: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)
Change in Salivary Cortisol Level
Change in physiological stress response measured by salivary cortisol levels between baseline (T1, pre-intervention on the morning of surgery) and post-intervention assessment (T2, 90-120 minutes before surgery).
Measured: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start27 Feb 2026 (estimated)
- Primary completion27 Apr 2026 (estimated)
- Study completion27 May 2026 (estimated)
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 Lumbar Disc HerniationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NURGÜL ARPAG, Assistant Professor,PhD, RN, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443111
- Sponsor's protocol ID
- BVU-20260206-VR
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, a final decision regarding the sharing of individual participant data (IPD) has not yet been made. Data sharing policies will be determined following study completion in accordance with institutional regulations, ethical approvals, and applicable data protection laws.
Publications
Asiri S, Currie J, Duff J, Guilhermino M. Effectiveness of virtual reality interventions for perioperative anxiety in adults: A systematic review with meta-analysis. Journal of Clinical Nursing. 2025;34:3539-3559. Moharam SA, et al. Effect of virtual reality on perioperative anxiety, stress and pain in total hip arthroplasty: A randomized controlled trial. BMC Anesthesiology. 2025;25:446. Karamad SP, Elahi A, Tabari F, Haghani S, Dehghan MF, Navidhamidi M. Evaluating the effect of preoperative provision of information on salivary cortisol in patients undergoing breast cancer surgery: A randomized controlled study. Journal of PeriAnesthesia Nursing. 2023;38:63-68. Topçu SY, Soydaş D, Özkan ZK, Ünver S, Orğan EM, Fındık ÜY. Turkish validity and reliability study of the Surgical Anxiety Questionnaire for adult patients. Journal of PeriAnesthesia Nursing. 2023;38:127-133.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effect of Virtual Reality-Based Preoperative Education on Surgical Anxiety Using Psychometric Measures and Salivary Cortisol: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07443111
- Acronym / sponsor ID
- BVU-20260206-VR
- Conditions
- Lumbar Disc Herniation, Preoperative Anxiety
- Keywords
- Virtual Reality, Lumbar Disc Herniation, Preoperative Anxiety, Salivary Cortisol, Randomized Controlled Trial, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 27 Feb 2026 (estimated)
- Primary completion
- 27 Apr 2026 (estimated)
- Study completion
- 27 May 2026 (estimated)
- First posted
- 2 Mar 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.
This randomized controlled pilot study aims to compare the effects of virtual reality-based preoperative education and routine preoperative education on surgical anxiety in patients undergoing lumbar disc surgery. In addition to evaluating psychological outcomes, the study will also compare psychometric anxiety assessments with a biological stress marker, salivary cortisol, to examine the relationship between subjective and physiological stress responses.
Preoperative anxiety is common among surgical patients and may negatively influence both emotional well-being and physiological stress regulation. Virtual reality-based education may provide a more immersive and engaging learning experience compared to routine education, potentially reducing anxiety levels.
Participants will be randomly assigned to either a virtual reality-based education group or a routine preoperative education group. Surgical anxiety will be assessed using validated psychometric measurement tools, and physiological stress response will be evaluated through salivary cortisol analysis. The study will further explore the concordance between psychometric findings and biological stress indicators.
The results may contribute to the development of innovative, evidence-based nursing interventions and provide insight into the relationship between psychological and biological indicators of preoperative anxiety.
Detailed description
This randomized controlled pilot trial is designed to evaluate the effectiveness of virtual reality-based preoperative education compared to routine preoperative education in adult patients scheduled for elective lumbar disc surgery. In addition to comparing anxiety levels between groups, the study aims to examine the relationship between psychometric assessments of surgical anxiety and the biological stress response measured by salivary cortisol.
Eligible participants will be adult patients undergoing elective lumbar disc surgery who meet the inclusion criteria and provide informed consent. Participants will be randomly allocated to one of two groups using a structured randomization process to ensure balanced distribution.
The intervention group will receive a structured virtual reality-based preoperative education session delivered through immersive technology explaining the surgical procedure, operating room environment, and perioperative process. The control group will receive routine preoperative education provided according to standard clinical practice. All participants will continue to receive standard medical and nursing care.
Data collection will be performed at predefined time points. Baseline measurements (T0) will be obtained prior to the educational intervention. Post-intervention anxiety assessments and salivary cortisol sampling (T1) will be conducted during the preoperative period before surgery. Surgical anxiety will be assessed using validated psychometric measurement instruments. Salivary cortisol levels will be analyzed as an objective indicator of physiological stress response.
The study will evaluate between-group differences in anxiety scores and cortisol levels. Additionally, the concordance and relationship between subjective psychometric measures and biological stress markers will be analyzed.
As a pilot study, the primary objectives include assessing feasibility, preliminary effectiveness, and methodological suitability for a future large-scale randomized trial. The findings may contribute to the development of evidence-based, technology-supported nursing interventions aimed at reducing preoperative anxiety and improving perioperative patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Based Preoperative Education | Experimental | Behavioral: Virtual Reality-Based Preoperative EducationParticipants in this arm receive virtual reality-based preoperative education using a head-mounted VR device on the day before lumbar disc surgery. The VR content provides structured information about the surgical process, operating room environment, anesthesia, and postoperative expectations. Psychological anxiety is assessed using validated psychometric scales, and salivary cortisol samples are collected to evaluate the physiological stress response. |
| Routine Preoperative Education | Active comparator | Behavioral: Routine Preoperative EducationParticipants in this arm receive routine preoperative education provided according to the hospital's standard clinical practice before lumbar disc surgery. The education includes verbal information about the surgical procedure, anesthesia, and postoperative care. Psychological anxiety is assessed using validated psychometric scales, and salivary cortisol samples are collected to evaluate the physiological stress response. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 65 years
- Hospitalized patients scheduled for elective lumbar disc herniation surgery in the preoperative period
- American Society of Anesthesiologists (ASA) physical status I-III
- Able to read and understand Turkish and be literate
- Sufficient cognitive capacity to understand the informed consent form (no advanced dementia, severe aphasia, impaired consciousness, or neurological/psychiatric condition interfering with communication)
Key exclusion criteria (13 listed)
- Presence of an emergency or urgent neurosurgical indication (e.g., traumatic acute subdural hematoma, acute intracranial hemorrhage with herniation signs)
- History of diagnosed epilepsy, particularly photosensitive epilepsy
- Severe cognitive impairment, severe aphasia, lack of cooperation, or altered level of consciousness
- History of psychiatric hospitalization within the last 6 months due to severe psychiatric disorders such as psychotic disorder, bipolar disorder, or severe major depressive disorder
- Chronic systemic steroid use or endocrine disorders significantly affecting adrenal cortex function (e.g., Cushing syndrome, Addison's disease)
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-Based Preoperative EducationVirtual reality-based structured preoperative education delivered via a head-mounted VR device before lumbar disc surgery. | Behavioural | Virtual Reality-Based Preoperative Education |
| Routine Preoperative EducationStandard verbal preoperative education provided according to hospital clinical practice before lumbar disc surgery. | Behavioural | Routine Preoperative Education |
Primary outcome
Change in Surgical Anxiety Level (SAQ Total Score)
Time frame: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)
Change in preoperative anxiety measured by the Surgical Anxiety Questionnaire (SAQ) total score between baseline (T1, pre-intervention on the morning of surgery) and post-intervention assessment (T2, 90-120 minutes before surgery).
Change in Salivary Cortisol Level
Time frame: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)
Change in physiological stress response measured by salivary cortisol levels between baseline (T1, pre-intervention on the morning of surgery) and post-intervention assessment (T2, 90-120 minutes before surgery).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- BackgroundAsiri S, Currie J, Duff J, Guilhermino M. Effectiveness of virtual reality interventions for perioperative anxiety in adults: A systematic review with meta-analysis. Journal of Clinical Nursing. 2025;34:3539-3559. Moharam SA, et al. Effect of virtual reality on perioperative anxiety, stress and pain in total hip arthroplasty: A randomized controlled trial. BMC Anesthesiology. 2025;25:446. Karamad SP, Elahi A, Tabari F, Haghani S, Dehghan MF, Navidhamidi M. Evaluating the effect of preoperative provision of information on salivary cortisol in patients undergoing breast cancer surgery: A randomized controlled study. Journal of PeriAnesthesia Nursing. 2023;38:63-68. Topçu SY, Soydaş D, Özkan ZK, Ünver S, Orğan EM, Fındık ÜY. Turkish validity and reliability study of the Surgical Anxiety Questionnaire for adult patients. Journal of PeriAnesthesia Nursing. 2023;38:127-133.
- Individual participant dataSharing planned: Undecided. At this stage, a final decision regarding the sharing of individual participant data (IPD) has not yet been made. Data sharing policies will be determined following study completion in accordance with institutional regulations, ethical approvals, and applicable data protection laws.
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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.
Nurgül Arpag, Assistant Professor, PhD, RN contact
NURGÜL ARPAG, Assistant Professor,PhD, RN principal investigator
Bezmialem Vakif University
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Preoperative Education and Routine Preoperative Education in people with Lumbar Disc Herniation and Preoperative Anxiety, run by Bezmialem Vakif University.
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 13 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: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurgül Arpag, Assistant Professor, PhD, RN (+90 212 401 26 00 ext. 4608, nurgul.arpag@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Surgical Anxiety Level (SAQ Total Score) (time frame: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)). 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 NCT07443111, 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 2 Mar 2026.