Ignite Creation Date:
2024-05-06 @ 1:57 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04172662
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2019-10-04
Brief Title:
Music Therapy as an Adjunct in CIED Lead Extraction Procedures
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Music Therapy as an Adjunct in Cardiac Implantable Electronic Device CIED Lead Extraction Procedures
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATH
Brief Summary:
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 andor 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
Detailed Description:
See study protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None