Carotid Artery DiseasesMEP-VASCNCT06704230
Stress Reduction Using Video Googles on Patients Undergoing Vascular Surgery
A study testing video googles in people with Carotid Artery Diseases and Regional Anesthesia, run by University Hospital Augsburg at 1 site in Germany.
Trial summary
One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases, Regional Anesthesia, Distress, Procedural
- What is being tested?
- video googles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2022to Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planed carotid endarterectomy in local anesthesia
Who cannot join
- patients which are not able to communicate because of stroke or language barrier,
- Dementia or neurological damage which impairs answering questionnaires or the understanding of the situation during surgery
- medication with steroids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas Millian contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Augsburg
Augsburg, Bavaria, 86156
Hagen Kerndl, +49 821 40 2655, hagen.kerndl@uk-augsburg.de
Thomas Millian
About this study
Official title: Multimedia Patient Entertainment During Vascular Surgery Procedures in Regional Anesthesia
One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. This approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. As a result, performing surgery under regional anesthesia provides therefor a benefit. However, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. The fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. Increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia.
In many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. In procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. For example, music and video goggles are employed to entertain and distract patients during the intervention. Newer approaches using video googles appear in more and more fields to reduce distress. Especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. Because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.
- Being tested
- video googles
- Keywords
- video googles, carotid endarterectomy, distress in patients, vascular surgery
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video googlesDevice
Also called multimedial distraction
Patients undergoing surgery use video googles and a headphone to distract from surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (+ video googles) | Experimental | Patients undergoging surgery, video googles are used during surgery to reduce patient distress Receives: Device: video googles |
| Control group (- video googles) | No intervention | Patients undergo surgery in the same way, no video googles or other devices for the reduction of distress is used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bloodserum cortisol levels
cortisol levels in the blood are measured on six specific times in the perioperative setting
Measured: Cortisol levels are measured six times the day the procedure is performed. Starting at 6:30am, Arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
Heartrate
The heart rate is measured on six specific times in the perioperative setting
Measured: The heartrate is measured six times the day the procedure is performed. Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
short questionnaire on current stress
The short questionnaire on current stress; is measured on six specific times in the perioperative setting.
It is a validated score to measure actual stress, there are 6 items, with 6 a scale one to six.
The minimal score is 6 (low distress) and 36 (high distress)
Measured: The questionnaire is asked six times the day the procedure is performed. Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
Richmond Agitation-Sedation Scale (RASS)
TheRichmond Agitation-Sedation Scale (RASS) is measured on six specific times in the perioperative setting.
It is a score typically used in anesthesia to measure agitation and sedation. The scale is from +4 (aggressive) over 0 (awake and calm) to -5 (deeply sleeping, not awakable)
Measured: RASS is measured six times the day the procedure is performed.Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
Spielberger State-Trait Anxiety Inventory (STAI)
This questionnaire ist is used to measure general and anxiety related to the current situation (upcoming surgery) Used are two questionnaires with 20 items each, after recoding the answers there is a numeric value for each questionnaire. High values suggest a high feeling of fear, low values, a low feeling of fear.
Measured: One Day. Day before surgery
Satisfaction (patient, surgeon, anesthesia)
After completing the surgery, all participation parties (patient, surgery and anesthesia) are asked to rate the surgery regarding to calmness of the patient, pain and distress. A numeric rating scale (0-10) is used.
Measured: One day. After surgery, within the next 24 hours
Next time again?
Patients in the interventional group are asked, if the would like to use the video googles again in case of an other surgery
Measured: One day. After surgery, within the next 24 hours
pain, distress, nervousness, fear
patients are asked if the feel one of the above (using no [1] - rather no [2] - not sure [3] - rather yes [4] - yes[5]) six specific times in the perioperative setting. For each quality (pain, distress, nervousness, fear) there is measured an individual value
Measured: Questions are asked six times the day the procedure is performed.Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start9 Sep 2022
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (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 Carotid Artery DiseasesStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Collaborators
- HappyMed GmbH (Wien, Austria)
- Responsible party
- Sponsor
- Investigators
- Alexander Hyhlik-Dürr, Prof. Dr., Study director, Vascular Surgery Faculty of Medicine University of Augsburg, Stenglinstr. 2 86156 Augsburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704230
- Sponsor's protocol ID
- 21-1199
- Acronym
- MEP-VASC
- Status last verified
- Nov 2024
- First submitted
- 25 Sep 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kerndl H, Millian TP, Gurtler K, Hyhlik-Duerr A. Measuring Stress Reduction in Patients Receiving Multimedia Entertainment During Vascular Surgery Under Regional Anesthesia: Protocol for a Randomized Controlled Study. JMIR Res Protoc. 2025 Jul 11;14:e70597. doi: 10.2196/70597.
PubMed 40644688
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimedia Patient Entertainment During Vascular Surgery Procedures in Regional Anesthesia
- ClinicalTrials.gov ID
- NCT06704230
- Acronym / sponsor ID
- MEP-VASC / 21-1199
- Keywords
- video googles, carotid endarterectomy, distress in patients, vascular surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Collaborators
- HappyMed GmbH (Wien, Austria)
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 26 Nov 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.
One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. This approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. As a result, performing surgery under regional anesthesia provides therefor a benefit. However, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. The fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. Increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia.
In many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. In procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. For example, music and video goggles are employed to entertain and distract patients during the intervention. Newer approaches using video googles appear in more and more fields to reduce distress. Especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. Because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (+ video googles) | Experimental | Device: video googlesPatients undergoging surgery, video googles are used during surgery to reduce patient distress |
| Control group (- video googles) | No intervention | –Patients undergo surgery in the same way, no video googles or other devices for the reduction of distress is used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planed carotid endarterectomy in local anesthesia
Key exclusion criteria (3 listed)
- patients which are not able to communicate because of stroke or language barrier,
- Dementia or neurological damage which impairs answering questionnaires or the understanding of the situation during surgery
- medication with steroids
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 |
|---|---|---|
| video googlesAlso: multimedial distractionPatients undergoing surgery use video googles and a headphone to distract from surgery | Device | Intervention group (+ video googles) |
Primary outcome
Bloodserum cortisol levels
Time frame: Cortisol levels are measured six times the day the procedure is performed. Starting at 6:30am, Arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
cortisol levels in the blood are measured on six specific times in the perioperative setting
Heartrate
Time frame: The heartrate is measured six times the day the procedure is performed. Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
The heart rate is measured on six specific times in the perioperative setting
short questionnaire on current stress
Time frame: The questionnaire is asked six times the day the procedure is performed. Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
The short questionnaire on current stress; is measured on six specific times in the perioperative setting. It is a validated score to measure actual stress, there are 6 items, with 6 a scale one to six. The minimal score is 6 (low distress) and 36 (high distress)
Richmond Agitation-Sedation Scale (RASS)
Time frame: RASS is measured six times the day the procedure is performed.Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
TheRichmond Agitation-Sedation Scale (RASS) is measured on six specific times in the perioperative setting. It is a score typically used in anesthesia to measure agitation and sedation. The scale is from +4 (aggressive) over 0 (awake and calm) to -5 (deeply sleeping, not awakable)
Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: One Day. Day before surgery
This questionnaire ist is used to measure general and anxiety related to the current situation (upcoming surgery) Used are two questionnaires with 20 items each, after recoding the answers there is a numeric value for each questionnaire. High values suggest a high feeling of fear, low values, a low feeling of fear.
Satisfaction (patient, surgeon, anesthesia)
Time frame: One day. After surgery, within the next 24 hours
After completing the surgery, all participation parties (patient, surgery and anesthesia) are asked to rate the surgery regarding to calmness of the patient, pain and distress. A numeric rating scale (0-10) is used.
Next time again?
Time frame: One day. After surgery, within the next 24 hours
Patients in the interventional group are asked, if the would like to use the video googles again in case of an other surgery
pain, distress, nervousness, fear
Time frame: Questions are asked six times the day the procedure is performed.Starting at 6:30am, arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR
patients are asked if the feel one of the above (using no [1] - rather no [2] - not sure [3] - rather yes [4] - yes[5]) six specific times in the perioperative setting. For each quality (pain, distress, nervousness, fear) there is measured an individual value
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 26 Nov 2024.
- Derived from this study: PubMed 40644688Kerndl H, Millian TP, Gurtler K, Hyhlik-Duerr A. Measuring Stress Reduction in Patients Receiving Multimedia Entertainment During Vascular Surgery Under Regional Anesthesia: Protocol for a Randomized Controlled Study. JMIR Res Protoc. 2025 Jul 11;14:e70597. doi: 10.2196/70597.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Millian contact
Alexander Hyhlik-Dürr, Prof. Dr. study director
Vascular Surgery Faculty of Medicine University of Augsburg, Stenglinstr. 2 86156 Augsburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video googles in people with Carotid Artery Diseases and Regional Anesthesia, run by University Hospital Augsburg at 1 site in Germany.
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 3 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 26 Nov 2024. 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 Germany. 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 Hagen Kerndl (+49 821 400 2655, hagen.kerndl@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bloodserum cortisol levels (time frame: Cortisol levels are measured six times the day the procedure is performed. Starting at 6:30am, Arraiving at the OR, dermal incision, clamping the carotid artery, dermal suture, one hour after leaving the OR). The study lists 8 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 NCT06704230, 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 26 Nov 2024.