Music Therapy as an Adjunct in CIED Lead Extraction Procedures

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

Patrocinadores

Patrocinador principal: Oslo University Hospital

Colaborador: Norwegian Academy of Music

Fuente Oslo University Hospital
Resumen breve

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.

Descripción detallada

See study protocol

Estado general Completed
Fecha de inicio March 1, 2018
Fecha de Terminación September 27, 2019
Fecha de finalización primaria September 27, 2019
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Patient satisfaction with pain management during the procedure 1 hour after completion of the procedure
Patient experience of pain intensity during the procedure Mean pain intensity during the procedure
Resultado secundario
Medida Periodo de tiempo
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
Inscripción 68
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Facilitated Music Listening

Descripción: 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.

Etiqueta de grupo de brazo: Music therapy group

Otro nombre: Music therapy

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 25 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Sigrun Halvorsen, Prof. MD PhD Principal Investigator Ullevaal University Hospital
Ubicación
Instalaciones: Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling
Ubicacion Paises

Norway

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Oslo University Hospital

Nombre completo del investigador: Sigrun Halvorsen

Título del investigador: Professor MD PhD

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Music therapy group

Tipo: Experimental

Descripción: Receive Music therapy in addition to standard treatment

Etiqueta: Control group

Tipo: No Intervention

Descripción: Receive standard treatment

Acrónimo MATH
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Randomized Controlled trial

Propósito primario: Supportive Care

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov