Massage Therapy for Self-efficacy in LVAD Recipients

NCT ID: NCT04018508

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-03-15

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 and/or 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 source.The 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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Massages

During routine clinic visits, subjects will receive a total of six 30-minute massages (one massage per week for 4 weeks, then one massage every two weeks for 4 weeks).

Group Type: EXPERIMENTAL

Massage

Intervention Type: OTHER

Massage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale)

Control

Subjects randomized to the control arm will also attend routine clinic visits at the same pre-prescribed intervals (one clinic visit per for 4 weeks, then one visit every two weeks for 4 weeks).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Massage

Massage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• capacitated, at least 18 years of age, received LVAD implant during last hospital admission

Exclusion Criteria

• incapacitated, non-English speaking, negative pressure isolation, unstable spine, very low serum platelets (<10,000/uL), received massage in 30 days prior to enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Hunter Groninger

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

STUDY00000591

Identifier Type: -

Identifier Source: org_study_id

NCT04851236

Identifier Type: -

Identifier Source: nct_alias