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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04172662
Other study ID # 2018/168
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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