Music Therapy as an Adjunct in CIED Lead Extraction Procedures

NCT ID: NCT04172662

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-09-27

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Music therapy group

Receive Music therapy in addition to standard treatment

Group Type: EXPERIMENTAL

Facilitated Music Listening

Intervention Type: BEHAVIORAL

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.

Control group

Receive standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Music therapy

Eligibility Criteria

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

Exclusion Criteria

1. Significant hearing impairment

2. Previous and/or acute psychiatric diagnosis

3. Cognitive and mental deficits or impaired functioning

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian Academy of Music

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sigrun Halvorsen

Professor MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sigrun Halvorsen, Prof. MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

Locations

Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling

Oslo, , Norway

Countries

Norway

Other Identifiers

2018/168

Identifier Type: -

Identifier Source: org_study_id