Music Therapy as an Adjunct in CIED Lead Extraction Procedures

NCT04172662 | Completed

• 1 other identifier: 2018/168
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Patient experience of anxiety level during the procedure

  Mean anxiety level during the procedure

• Effect on vital sign

  Mean arterial blood pressure during the procedure

• Consumption of analgetic drugs during the procedure

  Total amount of analgesic drug (fentanyl) given throughout the procedure

Study Arms (2)

Music therapy group

EXPERIMENTAL

Receive Music therapy in addition to standard treatment

Behavioral: Facilitated Music Listening

Control group

NO INTERVENTION

Receive standard treatment

Interventions

Facilitated Music Listening 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.

Also known as: Music therapy

Music therapy group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned pacemaker or intracardiac defibrillator (ICD) lead extraction performed in local anaesthesia.
• Lead implanted \> 12 months ago
• Able to speak and read Norwegian

You may not qualify if:

• Significant hearing impairment
• Previous and/or acute psychiatric diagnosis
• Cognitive and mental deficits or impaired functioning

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Academy of Music: collaborator

Study Sites (1)

Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling

Oslo, Norway

Location

MeSH Terms

Conditions

Pain, Procedural; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sigrun Halvorsen, Prof. MD PhD

  Ullevaal University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD PhD

Model Details: Randomized Controlled trial

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: November 21, 2019
• Study Start: March 1, 2018
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)