- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018508
Massage Therapy for Self-efficacy in LVAD Recipients
June 13, 2022 updated by: Hunter Groninger, Medstar Health Research Institute
Pilot Study of Massage Therapy to Improve Self-efficacy in Patients With Left-ventricular Device
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
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Massage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale)
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No Intervention: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-Efficacy for Managing Chronic Disease 6-item Scale from Baseline to Repeat Visits
Time Frame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
|
The Self-Efficacy for Managing Chronic Disease 6-item Scale is a psychometric scale that asks the subject 6 questions regarding confidence managing aspects of the chronic illness (fatigue, physical discomfort, emotional distress, non-pain symptoms, medication adherence, completing assigned health care related tasks).
Subjects respond to each question on a Likert scale from zero to 10 (zero="not confident at all"; 10="totally confident").
The score for the scale is the mean of the composite scores of the 6 Likert scales.
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1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in score on Brief COPE Inventory from baseline to repeat visits
Time Frame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
|
The Brief COPE is a 28-item multidimensional measure of strategies used for coping or regulating cognitions in response to stressors.
This abbreviated inventory (based on the complete 60-item COPE Inventory) is comprised of items that assess the frequency with which a person uses different coping strategies (e.g., "I've been turning to work or other activities to take my mind off things," "I've been making fun of the situation," "I've been criticizing myself") rated on a scale from 1, I haven't been doing this at all, to 4, I've been doing this a lot.
There are 14 two-item subscales within the Brief COPE, and each is analyzed separately: (1) self-distraction, (2) active coping, (3) denial, (4) substance use, (5) use of emotional support, (6) use of instrumental support, (7) behavioral disengagement, (8) venting, (9) positive reframing, (10) planning, (11) humor, (12) acceptance, (13) religion, and (14) self-blame.
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1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
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Change in score on National Comprehensive Cancer Network Distress Thermometer from baseline to repeat visits
Time Frame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
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The NCCN Distress Thermometer asks the patient to report his/her distress on a scale between 0 (no distress) and 10 (extreme distress).
The number provided on the scale is the patient's score.
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1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
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Change in score on McGill Quality of Life Scale (Revised) from baseline to repeat visits
Time Frame: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
|
The McGill Quality of Life Questionnaire (Revised) is a 15-item multidimensional tool designed to measure physical well-being, physical symptoms, psychological symptoms, existential well-being and support, as well as overall quality of life.
Created for people at all stages of a life-threatening illness (from diagnosis to cure or death), the MQOL(Revised) was designed to assess general domains applicable to all clients/patients, incorporate the existential domain, balance physical and nonphysical aspects of quality of life, and include both positive and negative influences on quality of life.
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1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
March 15, 2022
Study Completion (Actual)
March 15, 2022
Study Registration Dates
First Submitted
June 13, 2019
First Submitted That Met QC Criteria
July 11, 2019
First Posted (Actual)
July 12, 2019
Study Record Updates
Last Update Posted (Actual)
June 16, 2022
Last Update Submitted That Met QC Criteria
June 13, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000591
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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