Music Therapy as an Adjunct in CIED Lead Extraction Procedures (MATH)

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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety; Pain, Procedural; C.Surgical Procedure
• Intervention / Treatment: Behavioral: Facilitated Music Listening

Detailed Description

See study protocol

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music therapy group; Receive Music therapy in addition to standard treatment	Behavioral: Facilitated 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.; Other Names: Music therapy
No Intervention: Control group; Receive standard treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Norwegian Academy of Music
• Investigators: Principal Investigator: Sigrun Halvorsen, Prof. MD PhD, Ullevaal University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): September 27, 2019
• Study Completion (Actual): September 27, 2019

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural
• Other Study ID Numbers: 2018/168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No