Audiovisuell Distraction Via 2d Videoglasses During Catheter Ablation Procedures in Cardiac Rhythm Disorders.

NCT04873076 | Completed

• 1 other identifier: 18-8325-BO
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Rhythm; Disorder

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  during the procedure (electrophysiological examination on the heart)

Secondary Outcomes (1)

• Patient satisfaction

  evaluation before, immediately after and one day after the procedure

Study Arms (2)

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.

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.

Interventions

Audiovisual distraction using 2d video glasses from HappyMed GmbH DEVICE

Patients receive optical and acustical relaxing material during the procedure by using 2d video glasses from HappyMed GmbH

Audiovisual distraction using 2d video glasses from HappyMed GmbH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing catheter ablation for rhythm disorders

You may not qualify if:

• epilepsy
• age \<18 years
• visus \<-5 dpt or \>+2 dpt

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: May 5, 2021
• Study Start: November 20, 2019
• Primary Completion: March 13, 2020
• Study Completion: March 14, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)