Massage Therapy for Self-efficacy in LVAD Recipients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04018508|
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : September 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Other: Massage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Study of Massage Therapy to Improve Self-efficacy in Patients With Left-ventricular Device|
|Actual Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||October 31, 2022|
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).
Massage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale)
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).
- 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.
- 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.
- 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 ]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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018508
|United States, District of Columbia|
|MedStar Washington Hospital Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Hunter Groninger, MD 202-877-7445 firstname.lastname@example.org|
|Principal Investigator: Hunter Groninger, MD|