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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
68
The patient gets a preparatory session with the music therapist one day before the invasive procedure, where individual assessment is made based on a biopsychosocial approach. Sequences of facilitated Music listening is provided during the pre-, peri and postoperative phase, and a closing dialog performed postoperatively. Patient-preferred music is chosen from a limited set of playlists provided on the app The Music Star.
Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling
Oslo, Norway
Patient satisfaction with pain management during the procedure
10-point visual numeric scale, previously used in comparable studies. One represented very dissatisfied and 10 very satisfied
Time frame: 1 hour after completion of the procedure
Patient experience of pain intensity during the procedure
Numeric Rating Scale (NRS, 0-10)
Time frame: Mean pain intensity during the procedure
Patient experience of anxiety level during the procedure
Numeric Rating Scale (NRS, 0-10)
Time frame: Mean anxiety level during the procedure
Effect on vital sign
Mean arterial blood pressure during the procedure
Time frame: Mean arterial blood pressure during the procedure
Consumption of analgetic drugs during the procedure
Total need for fentanyl during the procedure, measured in mg
Time frame: Total amount of analgesic drug (fentanyl) given throughout the procedure
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