Music Therapy as an Adjunct in CIED Lead Extraction Procedures

Not Applicable

Completed

• Conditions: C.Surgical Procedure; Anxiety; Stress; Pain, Procedural
• Interventions: Behavioral: Facilitated Music Listening

• Registration Number: NCT04172662
• Lead Sponsor: Oslo University Hospital

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

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-09-27
• Study Completion: 2019-09-27
• Study First Submitted: 2019-10-04
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Study First Posted: 2019-11-21
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music therapy group	Facilitated Music Listening	Receive Music therapy in addition to standard treatment

Primary Outcome Measures

Name	Time	Method
Patient experience of pain intensity during the procedure	Mean pain intensity during the procedure	Numeric Rating Scale (NRS, 0-10)
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

Secondary Outcome Measures

Name	Time	Method
Patient experience of anxiety level during the procedure	Mean anxiety level during the procedure	Numeric Rating Scale (NRS, 0-10)
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 amount of analgesic drug (fentanyl) given throughout the procedure	Total need for fentanyl during the procedure, measured in mg

Trial Locations

Locations (1)

Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling; 🇳🇴 Oslo, Norway