Randomised study to investigate pain and Patient satisfaction with audiovisual distraction during Pacemaker and ICD-implantation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017420

Enrollment

200

Registered

2019-06-06

Start date

2019-03-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with indication for Implantation of a Pacemaker or ICD

Interventions

Group 1: Intervention with videoglasses Group 2: Intervention without Video glasses, Standard care

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: informed consent Patient >=18 years old Implantation, battery Exchange of a Pacemaker or ICD in local anesthesia

Exclusion criteria

Exclusion criteria: blindness psychiatric diseases (schizophrenia, dementia, Delir) injuries of the head which prevent the use of Video glasses patients with multiresistent germs pregnant women

Design outcomes

Primary

Measure	Time frame
Pain perception, evaluated with numeric Rating scale at different time Points before, during and after the intervention	—

Secondary

Measure	Time frame
amount of painkillers and sedatives during the procedure Evaluation of patient satisfaction with a numeric Rating scale	—

Countries

Germany

Contacts

Public ContactKerstin Bode

Herzzentrum Leipzig

kerstin.bode@helios-gesundheit.de0341 865 1413

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026