Anxiety and FearNCT06917300
Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery
A study testing Virtual Reality in people with Anxiety and Fear and Pain, Postoperative, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Anxiety and Fear, Pain, Postoperative, Stress
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 16 Aug 2024to 30 Sep 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients between 25-70 years old, undergoing an elective spinal surgery.
- Patient's admission prior to surgery day (at least 1 day).
- Expected hospital stay - 2 days.
- Capable of providing informed consent and participate in the study follow-up questionnaire.
- Patients speak Polish.
Who cannot join
- Congestive heart failure, hypertension and anti-hypertensive medications
- Adrenal insufficiency
- Alcohol addiction (evaluated by CAGE/AUDIT) and substance addiction (evaluated by DUDIT)
- Cognitive impairment (evaluated by MMSE, MoCA)
- Cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (Ishihara test), Simulator Sickness Questionnaire
- Auditory impairment
Show all 13Show fewer
- Psychiatric illness (schizophrenia, bipolar disorder, psychotic depression) - (evaluated by MINI questionnaire)
- Patients with neuropathic pain
- Use of sedative drugs, anti-depressants, anxiolytics, and anti-epileptic drugs
- Intracranial functional lesions (patients after TBI (Traumatic Brain Injury), cognitive or executive dysfunction)
- Patient with high risk due to major and emergency operations
- Claustrophobia
- GCS < 15
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Redwan Rahman Jabbar
Lodz, Łódź Voivodeship, 90-549
Redwan Jabbar, MD, PhD (Candid.), 0048570940828, rredwanbakal@gmail.com
Redwan Jabbar, MD
About this study
The aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Investigators hypothesize that the application of pre-operative VR-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.
- Conditions
- Anxiety and Fear, Pain, Postoperative, Stress
- Being tested
- Virtual Reality
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
The VR group will be exposed to a unified 15-minute VR video via phone using a VR device and goggles after receiving routine standard care. A 360˚ video with an immersive audio-visual environment describing pre-operative and post-operative experience on the day of the surgery will be provided, by which they can get accustomed to the environment and procedures associated with the surgery. Background audio will be provided through headsets, and the video will be directed by a neurosurgeon filmed using a Max 360 action VR camera. In the video, actors, neurosurgeons, and nurses will re-enact a typical day for a mock patient undergoing surgery, plus routine post-operative care, including the post-operative immediate recovery room and rehabilitation care by neurosurgeons, psychologists, and physiotherapists in the ward. Patients are allowed to move around freely so that they can experience all aspects of the virtual space, and are encouraged to ask questions at the end.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) Group - Hospital Environment Exposure | Experimental | This VR group will be exposed to a unified 15-minute VR video via phone using a VR device and goggles after receiving routine standard care. A 360˚ video with an immersive audio-visual environment describing pre-operative and post-operative experience on the day of the surgery will be provided, by which they can get accustomed to the environment and procedures associated with the surgery. Receives: Device: Virtual Reality |
| Virtual Reality (VR) Group - Nature Scenery Exposure | Active comparator | Patients within this group will be provided with standard routine care followed by VR exposure to an immersive environment (i.e., natural scenery, urban parks, tropical beaches, forests) with background music using a commercially available application (i.e., Nature Treks) through a head-mounted display (HMD) and headsets Receives: Device: Virtual Reality |
| Standard Care (Control) Group | No intervention | The standard group, in which patients will only receive standard care and be provided with routine descriptions of the pre-operative experience, where a surgeon will explain to them what the pre-operative experience would entail. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress (STAI-S) and Pain (VAS)
The Primary outcome for this trial is the change in the intensity of pre-operative anxiety measured by the State-Trait Anxiety Inventory (STA-I) scale and pain measured by visual Analogue Scale (VAS). These outcomes will be measured pre-operatively on the day before surgery. Measurements will be made again post-operatively - within 24 hours. Pre-operative and post-operative STAI-S and VAS will be compared for data analysis.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Satisfaction (EVAN-G) and Postoperative Stress (PSS-10)
The Secondary outcome will be the patients' quality of life and satisfaction measured by Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) questionnaire and postoperative stress measured by Perceived Stress Scale PSS-10 within 24 hours and used for data analysis, since the level of satisfaction and the stress caused by thinking time spent at pain can contribute to an increased perception of pain.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start16 Aug 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917300
- Sponsor's protocol ID
- RNN/02/24/KE
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery
- ClinicalTrials.gov ID
- NCT06917300
- Acronym / sponsor ID
- RNN/02/24/KE
- Conditions
- Anxiety and Fear, Pain, Postoperative, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 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 aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Investigators hypothesize that the application of pre-operative VR-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Group - Hospital Environment Exposure | Experimental | Device: Virtual RealityThis VR group will be exposed to a unified 15-minute VR video via phone using a VR device and goggles after receiving routine standard care. A 360˚ video with an immersive audio-visual environment describing pre-operative and post-operative experience on the day of the surgery will be provided, by which they can get accustomed to the environment and procedures associated with the surgery. |
| Virtual Reality (VR) Group - Nature Scenery Exposure | Active comparator | Device: Virtual RealityPatients within this group will be provided with standard routine care followed by VR exposure to an immersive environment (i.e., natural scenery, urban parks, tropical beaches, forests) with background music using a commercially available application (i.e., Nature Treks) through a head-mounted display (HMD) and headsets |
| Standard Care (Control) Group | No intervention | –The standard group, in which patients will only receive standard care and be provided with routine descriptions of the pre-operative experience, where a surgeon will explain to them what the pre-operative experience would entail. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients between 25-70 years old, undergoing an elective spinal surgery.
- Patient's admission prior to surgery day (at least 1 day).
- Expected hospital stay - 2 days.
- Capable of providing informed consent and participate in the study follow-up questionnaire.
- Patients speak Polish.
Key exclusion criteria (13 listed)
- Congestive heart failure, hypertension and anti-hypertensive medications
- Adrenal insufficiency
- Alcohol addiction (evaluated by CAGE/AUDIT) and substance addiction (evaluated by DUDIT)
- Cognitive impairment (evaluated by MMSE, MoCA)
- Cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (Ishihara test), Simulator Sickness Questionnaire
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 RealityThe VR group will be exposed to a unified 15-minute VR video via phone using a VR device and goggles after receiving routine standard care. A 360˚ video with an immersive audio-visual environment describing pre-operative and post-operative experience on the day of the surgery will be provided, by which they can get accustomed to the environment and procedures associated with the surgery. Background audio will be provided through headsets, and the video will be directed by a neurosurgeon filmed using a Max 360 action VR camera. In the video, actors, neurosurgeons, and nurses will re-enact a typical day for a mock patient undergoing surgery, plus routine post-operative care, including the post-operative immediate recovery room and rehabilitation care by neurosurgeons, psychologists, and physiotherapists in the ward. Patients are allowed to move around freely so that they can experience all aspects of the virtual space, and are encouraged to ask questions at the end. | Device | Virtual Reality (VR) Group - Hospital Environment Exposure, Virtual Reality (VR) Group - Nature Scenery Exposure |
Primary outcome
Stress (STAI-S) and Pain (VAS)
Time frame: 24 hours postoperatively
The Primary outcome for this trial is the change in the intensity of pre-operative anxiety measured by the State-Trait Anxiety Inventory (STA-I) scale and pain measured by visual Analogue Scale (VAS). These outcomes will be measured pre-operatively on the day before surgery. Measurements will be made again post-operatively - within 24 hours. Pre-operative and post-operative STAI-S and VAS will be compared for data analysis.
1 secondary outcome
Satisfaction (EVAN-G) and Postoperative Stress (PSS-10)
Time frame: 24 hours postoperatively
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 8 Apr 2025.
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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.
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 in people with Anxiety and Fear and Pain, Postoperative, run by Medical University of Lodz at 1 site in Poland.
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 5 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: looking for participants now, as of the sponsor's last update on 8 Apr 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 Poland. 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?
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 Redwan Jabbar, MD, PhD (Candid.) (0048570940828, rredwanbakal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (STAI-S) and Pain (VAS) (time frame: 24 hours postoperatively). 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 8 Apr 2025.