Virtual RealityPhase 4NCT06649383
Virtual Reality (VR) Could Be a Good Alternative to Relaxing or Pain-relieving Medication
A Phase 4 study testing Virtual reality in people with Virtual Reality and Distraction, run by Pether Jildenstal at 2 sites in Sweden.
Trial summary
We want to investigate whether Virtual Reality (VR) could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Distraction, Elderly (people Aged 65 or More)
- 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
- 90 participants
- Where
- 2 sitesSweden
- Study dates
- 16 Dec 2024to 15 Jun 2029
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- over 65 years, planed surgery in local anesthesia/regional anesthesia
Who cannot join
- dementia, unable to cooperate, cognitive impairment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Alingsås lasarett
Alingsås, Västra Götaland County, 441 33
Joakim Strömberg, associate professor, 0046313421000, joakim.stromberg@vgregion.se
- Recruiting
Sahlgrenska universitetssjukhuset
Gothenburg, Västra Götaland County, 414 72
Kristian Hermander, Nurse anesthetist, +46709374816, kristian.hermander@vgregion.se
Kristian Hermander
About this study
Official title: Virtual Reality for Elderly Patients in Anesthesia and Surgical Care
We want to investigate whether Virtual Reality (VR) could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia.
Read the detailed description
This study is a randomized controlled trial based on both quantitative and qualitative methods. Inclusion criteria are elderly patients aged ≥65 years with an estimated surgery time of a maximum of 90 minutes, who undergo surgery/treatment under local anesthesia and sedation. Randomization is to either standard sedation or sedation/VR. Randomization is carried out using mixed, sealed envelopes. The studies will be conducted at the following locations:
Hallands Hospital, Kungsbacka: Open inguinal hernia surgery with implant, anesthesia type is infiltration anesthesia.
Sahlgrenska Hospital: Intervention, cannulation of the groin and vascular surgery performed via catheters/guides on blood vessels, liver, pancreas, and abdominal organs, with anesthesia type infiltration.
Alingsås Hospital: Surgery on the hand, arm, lower extremity, urology, with anesthesia type block and infiltration.
Data collection will include baseline preoperative stress levels measured with The State-Trait Anxiety Inventory (STAI-S) and pain assessment using a numerical rating scale (NRS) from 0-11.
We also plan to use an objective marker for measuring anxiety-induced stress perioperatively, such as heart rate variability or skin conductance measurement. Postoperative data will include STAI-S, NRS, intraoperative sedative medication (type and dosage in mg/kg), time to urination, time to oral nutrition, discharge time, and time spent in the postoperative ward.
The patient will assess their well-being with the QoR 15 and NRS during the first five days postoperatively. The patient will be contacted to schedule a follow-up individual interview with semi-structured questions via Zoom two weeks after the surgery.
The primary outcome effect of VR glasses on mg/kg of propofol used intraoperatively or another sedative drug and/or the amount of local anesthetic used in mg. The secondary outcome effect of VR glasses on anxiety-induced stress perioperatively, where data collection will be conducted using EEG spectral edge frequency and The State-Trait Anxiety Inventory (STAI-S).
- Being tested
- Virtual reality
- Keywords
- virtual reality, distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Participant will try virtual reality glasses with tailormade software films to see if it's possible to use them as distraction during awake surgery. We will measure doses of propofol given, level of anxiety, experience of the patient and surgeons satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | This group use VR glasses during surgery Receives: Device: Virtual reality |
| Control group | No intervention | Control group without intervention, conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
propofol mg/kg
dose of propofol given during surgery to the participant
Measured: during the surgery (90 minutes max)
Secondary outcomes (4)
Surgeons satisfaction
surgeons satisfaction, measured with NASA task load index (tlx). Higher score, worse outcome.
Measured: Directly after surgery is finished
Stress/anxiety
Stress or anxiety felt during surgery by participant, measured with State-Trait Anxiety Inventory (STAI) . Higher score worse outcome.
Measured: during the surgery (90 minutes max)
Nurse anesthetists experience, (questionnaire).
Nurse anesthetists experience will be measured with a questionnaire egarding how well the monitoring of the patient could be carried out and the degree to which the patient was perceived as calm. The higher score, the better.
Measured: Directly after surgery is finished
Level of pain
Patients level of pain after surgery, measured with Numeric rating scale (NRS). The higher scores mean worse outcome.
Measured: Directly after surgery is finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start16 Dec 2024
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pether Jildenstal
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor-investigator, Pether Jildenstal, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649383
- Sponsor's protocol ID
- 2023-04059-01
- Other IDs
- 2023
- Status last verified
- Jan 2025
- First submitted
- 17 Oct 2024
- Last updated
- 13 Jan 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Elderly Patients in Anesthesia and Surgical Care
- ClinicalTrials.gov ID
- NCT06649383
- Acronym / sponsor ID
- 2023-04059-01
- Keywords
- virtual reality, distraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pether JildenstalUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 18 Oct 2024 (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.
We want to investigate whether Virtual Reality (VR) could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia.
Detailed description
This study is a randomized controlled trial based on both quantitative and qualitative methods. Inclusion criteria are elderly patients aged ≥65 years with an estimated surgery time of a maximum of 90 minutes, who undergo surgery/treatment under local anesthesia and sedation. Randomization is to either standard sedation or sedation/VR. Randomization is carried out using mixed, sealed envelopes. The studies will be conducted at the following locations:
Hallands Hospital, Kungsbacka: Open inguinal hernia surgery with implant, anesthesia type is infiltration anesthesia.
Sahlgrenska Hospital: Intervention, cannulation of the groin and vascular surgery performed via catheters/guides on blood vessels, liver, pancreas, and abdominal organs, with anesthesia type infiltration.
Alingsås Hospital: Surgery on the hand, arm, lower extremity, urology, with anesthesia type block and infiltration.
Data collection will include baseline preoperative stress levels measured with The State-Trait Anxiety Inventory (STAI-S) and pain assessment using a numerical rating scale (NRS) from 0-11.
We also plan to use an objective marker for measuring anxiety-induced stress perioperatively, such as heart rate variability or skin conductance measurement. Postoperative data will include STAI-S, NRS, intraoperative sedative medication (type and dosage in mg/kg), time to urination, time to oral nutrition, discharge time, and time spent in the postoperative ward.
The patient will assess their well-being with the QoR 15 and NRS during the first five days postoperatively. The patient will be contacted to schedule a follow-up individual interview with semi-structured questions via Zoom two weeks after the surgery.
The primary outcome effect of VR glasses on mg/kg of propofol used intraoperatively or another sedative drug and/or the amount of local anesthetic used in mg. The secondary outcome effect of VR glasses on anxiety-induced stress perioperatively, where data collection will be conducted using EEG spectral edge frequency and The State-Trait Anxiety Inventory (STAI-S).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Virtual realityThis group use VR glasses during surgery |
| Control group | No intervention | –Control group without intervention, conventional treatment |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- over 65 years, planed surgery in local anesthesia/regional anesthesia
Key exclusion criteria (1 listed)
- dementia, unable to cooperate, cognitive impairment
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 realityParticipant will try virtual reality glasses with tailormade software films to see if it's possible to use them as distraction during awake surgery. We will measure doses of propofol given, level of anxiety, experience of the patient and surgeons satisfaction. | Device | VR group |
Primary outcome
propofol mg/kg
Time frame: during the surgery (90 minutes max)
dose of propofol given during surgery to the participant
4 secondary outcomes
Surgeons satisfaction
Time frame: Directly after surgery is finished
Stress/anxiety
Time frame: during the surgery (90 minutes max)
Nurse anesthetists experience, (questionnaire).
Time frame: Directly after surgery is finished
Level of pain
Time frame: Directly after surgery is finished
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 13 Jan 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Virtual reality in people with Virtual Reality and Distraction, run by Pether Jildenstal at 2 sites in Sweden.
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 1 inclusion and 1 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 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Pether Jildenstål, Docent (+46760266658, pether.jildenstal@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
propofol mg/kg (time frame: during the surgery (90 minutes max)). 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 13 Jan 2025.