Rhythm; DisorderNCT04873076
Audiovisuell Distraction Via 2d Videoglasses During Catheter Ablation Procedures in Cardiac Rhythm Disorders.
A study testing Audiovisual distraction using 2d video glasses from HappyMed GmbH in people with Rhythm; Disorder, run by University Hospital, Essen at 1 site in Germany.
Trial summary
In this randomized controlled trial, amount of sedation exposure and patient satisfaction is evaluated in patients undergoing catheter ablation for rhythm disorders via an audiovisual distraction. Patients are randomized into intervention group (adiovisual distraction) or controll (no intervention). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhythm; Disorder
- What is being tested?
- Audiovisual distraction using 2d video glasses from HappyMed GmbH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2019to 14 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing catheter ablation for rhythm disorders
Who cannot join
- epilepsy
- age <18 years
- visus <-5 dpt or >+2 dpt
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change of Analgosedation (Remifentanil) Dosage and Increased Patient Satisfaction During Catheter Ablation Procedures in Cardiac Rhythm Disorders Via 2d Audiovisual Distraction.
In this randomized controlled trial, amount of sedation exposure and patient satisfaction is evaluated in patients undergoing catheter ablation for rhythm disorders via an audiovisual distraction. Patients are randomized into intervention group (adiovisual distraction) or controll (no intervention).
Read the detailed description
Study conduct:
After the patient has been informed and given written consent to participate in the study, the patients are randomized. They are either assigned to the control group (in which catheter ablation will take place without video glasses as before) or to the intervention group in which they receive the video glasses during ablation. The randomization into the two groups is done by random allocation.
The patients in the intervention group receive instruction on how to use the video glasses and can familiarize themselves with them. Before the patient (as well in the intervention as in the control group) is taken to the EPU laboratory, he receives the first questionnaire in which the personal data and his mood / feeling of fear are collected. In addition, two questions on instrumental-qualification media studies should give an indication of possible relationships between the evaluation of video glasses. The patient is then led into the laboratory and connected to the monitoring by the team. Before it is covered under sterile conditions, the patients in the intervention group receive the glasses and remote control with which they can select the footage from the media library.
The anesthetist will inject a basic dose of sedative and analgesic (determined on the basis of body weight) into each patient and increase it if pain or agitation is noticeable. All patients receive their individual dosage to ensure painless ablation. During the examination, the vital parameters (blood pressure and heart rate) are documented at specified times.
After completing catheter ablation, the video glasses (for patients from the intervention group) are removed. The patients receive a second questionnaire in which they evaluate the use of the video glasses.
Both the subjects in the intervention and control groups are asked to estimate the duration of the examination. The subjective sense of time is intended to provide information as to whether the patients in the intervention group experienced adequate distraction compared to the patients in the control group.
Follow-up:
On the day after catheter ablation all patients receive the CSQ 8 questionnaire, which assesses patient satisfaction using categorical questions. A longer-term follow-up is not necessary.
- Conditions
- Rhythm; Disorder
- Being tested
- Audiovisual distraction using 2d video glasses from HappyMed GmbH
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual distraction using 2d video glasses from HappyMed GmbHDevice
Patients receive optical and acustical relaxing material during the procedure by using 2d video glasses from HappyMed GmbH
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual distraction using 2d video glasses from HappyMed GmbH | Experimental | During the catheter ablation, the patients in the intervention group receive 2D video glasses with headphones. Immediately before and after the procedure they receive a questionnaire. During the procedure vital parameters of all patients regardless of the studygroup are monitored using "Zoll X-Series Monitor Defibrillator. The study includes blood pressure (in mmHg), heart rate (in beats per minute) and patient's level of alertness, which is assessed using the Richmond Agitation-Sedation Scale(RAAS). During the procedure the patients in the intervention group receive the glasses and remote control. All patients receive their individual dosage to ensure painless ablation. The drugs used are limited to the opioids remifentanil and benzodiazepine midazolam. Receives: Device: Audiovisual distraction using 2d video glasses from HappyMed GmbH |
| Controll arm | No intervention | In patients in the control group, catheter ablation is performed as usual without the use of video glasses. They receive immediately before and after the ablation the same questionnaire as the patients in experimental arm. (Omitting the question about the videoglasses). While the procedure is performed, the analgosediation is as well in the controll arm as in the experimental arm titrated until the patient is treated, sedated and painless. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of analgosedation dosage
The change of analgosedation dose is measured by comparing the amount of sedation necessary for the procedure in experimental and controll arm.
Remifentanyl (Ultiva) is measured in µg/kg/hour Midazolam (Dormicum) is measured in mg/kg/hour
Measured: during the procedure (electrophysiological examination on the heart)
Change of stress and anxiety level
The vital parameter blood pressure (in mmHg) serve as surrogate parameter for anxiety and stress.
Measured: during the procedure (electrophysiological examination on the heart)
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction is assessed using the established Client Satisfaction Questionnaire (CSQ-8). It consists of eight items on ordinal scale level. Each question has formulated answer options that correspond to a value from 1 to 4 with higher scores indicating higher satisfaction. The total score can range from 8 to 32.
Measured: evaluation before, immediately after and one day after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start20 Nov 2019
- Primary completion13 Mar 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhythm; DisorderStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873076
- Sponsor's protocol ID
- 18-8325-BO
- Status last verified
- Apr 2021
- First submitted
- 25 Jan 2020
- Last updated
- 5 May 2021
- 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 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Analgosedation (Remifentanil) Dosage and Increased Patient Satisfaction During Catheter Ablation Procedures in Cardiac Rhythm Disorders Via 2d Audiovisual Distraction.
- ClinicalTrials.gov ID
- NCT04873076
- Acronym / sponsor ID
- 18-8325-BO
- Conditions
- Rhythm; Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 5 May 2021 (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.
In this randomized controlled trial, amount of sedation exposure and patient satisfaction is evaluated in patients undergoing catheter ablation for rhythm disorders via an audiovisual distraction. Patients are randomized into intervention group (adiovisual distraction) or controll (no intervention).
Detailed description
Study conduct:
After the patient has been informed and given written consent to participate in the study, the patients are randomized. They are either assigned to the control group (in which catheter ablation will take place without video glasses as before) or to the intervention group in which they receive the video glasses during ablation. The randomization into the two groups is done by random allocation.
The patients in the intervention group receive instruction on how to use the video glasses and can familiarize themselves with them. Before the patient (as well in the intervention as in the control group) is taken to the EPU laboratory, he receives the first questionnaire in which the personal data and his mood / feeling of fear are collected. In addition, two questions on instrumental-qualification media studies should give an indication of possible relationships between the evaluation of video glasses. The patient is then led into the laboratory and connected to the monitoring by the team. Before it is covered under sterile conditions, the patients in the intervention group receive the glasses and remote control with which they can select the footage from the media library.
The anesthetist will inject a basic dose of sedative and analgesic (determined on the basis of body weight) into each patient and increase it if pain or agitation is noticeable. All patients receive their individual dosage to ensure painless ablation. During the examination, the vital parameters (blood pressure and heart rate) are documented at specified times.
After completing catheter ablation, the video glasses (for patients from the intervention group) are removed. The patients receive a second questionnaire in which they evaluate the use of the video glasses.
Both the subjects in the intervention and control groups are asked to estimate the duration of the examination. The subjective sense of time is intended to provide information as to whether the patients in the intervention group experienced adequate distraction compared to the patients in the control group.
Follow-up:
On the day after catheter ablation all patients receive the CSQ 8 questionnaire, which assesses patient satisfaction using categorical questions. A longer-term follow-up is not necessary.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audiovisual distraction using 2d video glasses from HappyMed GmbH | Experimental | Device: Audiovisual distraction using 2d video glasses from HappyMed GmbHDuring the catheter ablation, the patients in the intervention group receive 2D video glasses with headphones. Immediately before and after the procedure they receive a questionnaire. During the procedure vital parameters of all patients regardless of the studygroup are monitored using "Zoll X-Series Monitor Defibrillator. The study includes blood pressure (in mmHg), heart rate (in beats per minute) and patient's level of alertness, which is assessed using the Richmond Agitation-Sedation Scale(RAAS). During the procedure the patients in the intervention group receive the glasses and remote control. All patients receive their individual dosage to ensure painless ablation. The drugs used are limited to the opioids remifentanil and benzodiazepine midazolam. |
| Controll arm | No intervention | –In patients in the control group, catheter ablation is performed as usual without the use of video glasses. They receive immediately before and after the ablation the same questionnaire as the patients in experimental arm. (Omitting the question about the videoglasses). While the procedure is performed, the analgosediation is as well in the controll arm as in the experimental arm titrated until the patient is treated, sedated and painless. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing catheter ablation for rhythm disorders
Key exclusion criteria (3 listed)
- epilepsy
- age <18 years
- visus <-5 dpt or >+2 dpt
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 |
|---|---|---|
| Audiovisual distraction using 2d video glasses from HappyMed GmbHPatients receive optical and acustical relaxing material during the procedure by using 2d video glasses from HappyMed GmbH | Device | Audiovisual distraction using 2d video glasses from HappyMed GmbH |
Primary outcome
Change of analgosedation dosage
Time frame: during the procedure (electrophysiological examination on the heart)
The change of analgosedation dose is measured by comparing the amount of sedation necessary for the procedure in experimental and controll arm. Remifentanyl (Ultiva) is measured in µg/kg/hour Midazolam (Dormicum) is measured in mg/kg/hour
Change of stress and anxiety level
Time frame: during the procedure (electrophysiological examination on the heart)
The vital parameter blood pressure (in mmHg) serve as surrogate parameter for anxiety and stress.
1 secondary outcome
Patient satisfaction
Time frame: evaluation before, immediately after and one day after the procedure
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 5 May 2021.
- Individual participant dataSharing planned: No
Related trials for Rhythm; Disorder
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual distraction using 2d video glasses from HappyMed GmbH in people with Rhythm; Disorder, run by University Hospital, Essen 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: finished, as of the sponsor's last update on 5 May 2021. 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?
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?
Change of analgosedation dosage (time frame: during the procedure (electrophysiological examination on the heart)). 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?
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 5 May 2021.