Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling
Oslo, Norway
NCT Number: NCT04172662
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.
Looking for future studies?
Notify Me25 year–80 year
All sexes
Interventional
Not applicable
Oslo, Norway
See study protocol
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Mean pain intensity during the procedure
Numeric Rating Scale (NRS, 0-10)
Time frame: Mean anxiety level during the procedure
Numeric Rating Scale (NRS, 0-10)
Time frame: Mean arterial blood pressure during the procedure
Mean arterial blood pressure 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
Oslo University Hospital
Other
Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures
Acronym: MATH
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.
Published trials that share one or more normalized conditions with this study.
NCT03241290
C.Surgical Procedure
Grenoble, France
View Trial DetailsNCT06466551
Agnosia, Anxiety
Mersin, Turkey (Türkiye)
View Trial DetailsNCT03680625
Acute Pain, Agnosia
Montreal, Quebec, Canada
View Trial DetailsNCT05288309
Anxiety, Anxiety Disorders
Center, Erzi̇ncan, Turkey (Türkiye)
View Trial Details