Anxiety, C.Surgical Procedure, Pain, Procedural, Stress
Conditions
Brief summary
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.
Detailed description
See study protocol
Interventions
BEHAVIORALFacilitated Music Listening
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.
Sponsors
Norwegian Academy of Music
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized Controlled trial
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Planned pacemaker or intracardiac defibrillator (ICD) lead extraction performed in local anaesthesia. 2. Lead implanted \> 12 months ago 3. Able to speak and read Norwegian 4. Willing to participate All inclusion criteria must be fulfilled.
Exclusion criteria
1. Significant hearing impairment 2. Previous and/or acute psychiatric diagnosis 3. Cognitive and mental deficits or impaired functioning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with pain management during the procedure | 1 hour after completion of the procedure | 10-point visual numeric scale, previously used in comparable studies. One represented very dissatisfied and 10 very satisfied |
| Patient experience of pain intensity during the procedure | Mean pain intensity during the procedure | Numeric Rating Scale (NRS, 0-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on vital sign | Mean arterial blood pressure during the procedure | Mean arterial blood pressure during the procedure |
| Patient experience of anxiety level during the procedure | Mean anxiety level during the procedure | Numeric Rating Scale (NRS, 0-10) |
| Consumption of analgetic drugs during the procedure | Total amount of analgesic drug (fentanyl) given throughout the procedure | Total need for fentanyl during the procedure, measured in mg |
Countries
Norway
Outcome results
None listed