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OpenTrials
Completed

NCT Number: NCT04172662

Music Therapy as an Adjunct in CIED Lead Extraction Procedures

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.

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling

Oslo, Norway

About this study

See study protocol

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Music therapy

Primary outcomes

  1. Patient satisfaction with pain management during the procedure

    Time frame: 1 hour after completion of the procedure

    10-point visual numeric scale, previously used in comparable studies. One represented very dissatisfied and 10 very satisfied

  2. Patient experience of pain intensity during the procedure

    Time frame: Mean pain intensity during the procedure

    Numeric Rating Scale (NRS, 0-10)

Secondary outcomes

  1. Patient experience of anxiety level during the procedure

    Time frame: Mean anxiety level during the procedure

    Numeric Rating Scale (NRS, 0-10)

  2. Effect on vital sign

    Time frame: Mean arterial blood pressure during the procedure

    Mean arterial blood pressure during the procedure

  3. Consumption of analgetic drugs during the procedure

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

    Total need for fentanyl during the procedure, measured in mg

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Academy of Music

Registry information

Official study title

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

Acronym: MATH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2019
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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