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| Name | Class |
|---|---|
| Norwegian Academy of Music | OTHER |
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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.
See study protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music therapy group | Experimental | Receive Music therapy in addition to standard treatment |
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| Control group | No Intervention | Receive standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient experience of pain intensity during the procedure | Numeric Rating Scale (NRS, 0-10) | Mean pain intensity during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient experience of anxiety level during the procedure | Numeric Rating Scale (NRS, 0-10) | Mean anxiety level during the procedure |
| Effect on vital sign | Mean arterial blood pressure during the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sigrun Halvorsen, Prof. MD PhD | Ullevaal University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling | Oslo | Norway |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Randomized Controlled trial
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|
| Mean arterial blood pressure during the procedure |
| 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 |
| D001523 | Mental Disorders |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |