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Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures
The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. The procedure is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are given at the start of the procedure, and repeated if needed. In spite of the drugs, most patients will experience som degree of pain and/or anxiety and increased stress during the procedure. The music therapy intervention contains individually facilitated music listening and coping techniques, aiming to regulate stress responses. The music listening and guidance is provided by a certified music therapist before, during and after the invasive procedure.
See study protocol
Age
25 - 80 years
Sex
ALL
Healthy Volunteers
No
Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling
Oslo, Norway
Start Date
March 1, 2018
Primary Completion Date
September 27, 2019
Completion Date
September 27, 2019
Last Updated
November 21, 2019
68
ACTUAL participants
Facilitated Music Listening
BEHAVIORAL
Lead Sponsor
Oslo University Hospital
Collaborators
NCT07360600
NCT07478393
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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