Music Therapy as an Adjunct in CIED Lead Extraction Procedures

Study Overview
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Brief Summary
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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
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See study protocol

Official Title
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Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures

Conditions
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C.Surgical Procedure, Stress, Pain, Procedural, Anxiety

Intervention / Treatment
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* Behavioral: Facilitated Music Listening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music therapy group<br>Receive Music therapy in addition to standard treatment | Behavioral: Facilitated Music Listening<br>* 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.<br>* Other names: Music therapy;|
| No Intervention: Control group<br>Receive standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 hour after completion of the procedure | 
| Patient experience of pain intensity during the procedure | Numeric Rating Scale (NRS, 0-10) | Mean pain intensity during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient experience of anxiety level during the procedure | Numeric Rating Scale (NRS, 0-10) | Mean anxiety level during the procedure | 
| Effect on vital sign | Mean arterial blood pressure during the procedure | Mean arterial blood pressure during the procedure | 
| Consumption of analgetic drugs during the procedure | Total need for fentanyl during the procedure, measured in mg | Total amount of analgesic drug (fentanyl) given throughout the procedure |