Music Therapy as an Adjunct in CIED Lead Extraction Procedures

Anxiety Clinical Trial

— MATH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172662
• Other study ID #: 2018/168
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: September 27, 2019

Study information

• Verified date: November 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See study protocol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Academy of Music

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient experience of pain intensity during the procedure	Numeric Rating Scale (NRS, 0-10)	Mean pain intensity during the procedure
Secondary	Patient experience of anxiety level during the procedure	Numeric Rating Scale (NRS, 0-10)	Mean anxiety level during the procedure
Secondary	Effect on vital sign	Mean arterial blood pressure during the procedure	Mean arterial blood pressure during the procedure
Secondary	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