Anxiety Clinical Trial
— MATHOfficial title:
Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures
Verified date | November 2019 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital, Ullevål, Hjertemedisinsk avdeling | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Norwegian Academy of Music |
Norway,
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 |
Status | Clinical Trial | Phase | |
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