search
Back to results

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

Primary Purpose

C.Surgical Procedure, Stress, Pain, Procedural

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Facilitated Music Listening
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for C.Surgical Procedure

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music therapy group

Control group

Arm Description

Receive Music therapy in addition to standard treatment

Receive standard treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient experience of anxiety level during the procedure
Numeric Rating Scale (NRS, 0-10)
Effect on vital sign
Mean arterial blood pressure during the procedure
Consumption of analgetic drugs during the procedure
Total need for fentanyl during the procedure, measured in mg

Full Information

First Posted
October 4, 2019
Last Updated
November 19, 2019
Sponsor
Oslo University Hospital
Collaborators
Norwegian Academy of Music
search

1. Study Identification

Unique Protocol Identification Number
NCT04172662
Brief Title
Music Therapy as an Adjunct in CIED Lead Extraction Procedures
Acronym
MATH
Official Title
Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Academy of Music

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C.Surgical Procedure, Stress, Pain, Procedural, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music therapy group
Arm Type
Experimental
Arm Description
Receive Music therapy in addition to standard treatment
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Receive standard treatment
Intervention Type
Behavioral
Intervention Name(s)
Facilitated Music Listening
Other Intervention Name(s)
Music therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient satisfaction with pain management during the procedure
Description
10-point visual numeric scale, previously used in comparable studies. One represented very dissatisfied and 10 very satisfied
Time Frame
1 hour after completion of the procedure
Title
Patient experience of pain intensity during the procedure
Description
Numeric Rating Scale (NRS, 0-10)
Time Frame
Mean pain intensity during the procedure
Secondary Outcome Measure Information:
Title
Patient experience of anxiety level during the procedure
Description
Numeric Rating Scale (NRS, 0-10)
Time Frame
Mean anxiety level during the procedure
Title
Effect on vital sign
Description
Mean arterial blood pressure during the procedure
Time Frame
Mean arterial blood pressure during the procedure
Title
Consumption of analgetic drugs during the procedure
Description
Total need for fentanyl during the procedure, measured in mg
Time Frame
Total amount of analgesic drug (fentanyl) given throughout the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Planned pacemaker or intracardiac defibrillator (ICD) lead extraction performed in local anaesthesia. Lead implanted > 12 months ago Able to speak and read Norwegian Willing to participate All inclusion criteria must be fulfilled. Exclusion Criteria: Significant hearing impairment Previous and/or acute psychiatric diagnosis Cognitive and mental deficits or impaired functioning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigrun Halvorsen, Prof. MD PhD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Music Therapy as an Adjunct in CIED Lead Extraction Procedures

We'll reach out to this number within 24 hrs