Ignite Creation Date:
2024-05-06 @ 1:25 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04018508
Status:
TERMINATED
Last Update Posted:
2022-06-16
First Post:
2019-06-13
Brief Title:
Massage Therapy for Self-efficacy in LVAD Recipients
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Pilot Study of Massage Therapy to Improve Self-efficacy in Patients With Left-ventricular Device
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID19 pandemic closed in-person clinics LVAD surgeon left institution stopping LVAD implants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study evaluates the role of massage therapy to improve self-efficacy in patients with advanced heart failure who have recently received a left-ventricular assist device In addition to usual care half of the volunteer patients will receive a massage at regular clinic visits and half will not receive any massage
Detailed Description:
Patients with advanced heart failure who undergo left-ventricular assist device LVAD implantation may experience notable physical andor emotional distress associated with this lifestyle-changing procedure Furthermore these patients are faced with the task of coping with the trauma of surgery creating new self-care routines and learning to live with a lifesaving mechanical device that must always be connected to a power sourceThe immediate weeks and months after LVAD implantation are a critical period to lower physical and emotional distress and to influence patient coping and adaptation In small studies massage therapy has been increasingly used to improve patient self-efficacy and coping In this pilot study we investigate whether regularly scheduled massages delivered in the clinic setting improve self-efficacy and coping in this select patient population
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