Music Therapy as an Adjunct in CIED Lead Extraction Procedures (MATH)
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Details and patient eligibility
About
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.
Full description
See study protocol
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Planned pacemaker or intracardiac defibrillator (ICD) lead extraction performed in local anaesthesia.
- Lead implanted > 12 months ago
- Able to speak and read Norwegian
- Willing to participate All inclusion criteria must be fulfilled.
Exclusion criteria
- Significant hearing impairment
- Previous and/or acute psychiatric diagnosis
- Cognitive and mental deficits or impaired functioning
Trial design
Primary purpose
Allocation
Interventional model
Masking
68 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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