Clinical trial NCT04873076: Audiovisuell Distraction Via 2d Videoglasses During Catheter Ablation Procedures in Cardiac Rhythm Disorders.
Official title: Change of Analgosedation (Remifentanil) Dosage and Increased Patient Satisfaction During Catheter Ablation Procedures in Cardiac Rhythm Disorders Via 2d Audiovisual Distraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhythm; Disorder
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing catheter ablation for rhythm disorders

Exclusion Criteria:

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

Primary outcomes:
measure: Change of analgosedation dosage
timeFrame: during the procedure (electrophysiological examination on the heart)
measure: Change of stress and anxiety level
timeFrame: during the procedure (electrophysiological examination on the heart)
Secondary outcomes:
measure: Patient satisfaction
timeFrame: evaluation before, immediately after and one day after the procedure
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: NRW
Study officials:
References: