Healing Touch Prior to Cardiac Rehab - Trial NCT02695134
Access comprehensive clinical trial information for NCT02695134 through Pure Global AI's free database. This phase not specified trial is sponsored by Scripps Health and is currently status unknown. The study focuses on Heart Disease. Target enrollment is 124 participants.
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Study Focus
Sponsor & Location
Scripps Health
Timeline & Enrollment
N/A
Feb 01, 2016
Jun 01, 2019
Primary Outcome
Number of participants with an improvement in stress and anxiety symptoms as measured by Dartmouth Quality of Life Index scores,Number of participants with an improvement in stress and anxiety symptoms as measured by SF-36 scores
Summary
The purpose of the investigators proposed randomized, controlled study is to examine the
 effect of 6 one hour treatments of Healing Touch (HT) over 3 weeks on post-cardiac event
 patients, while they wait to enter a Cardiac Rehab (CR) program.Patients enrolled in the
 Scripps Center for Integrative Medicine (SCIM) Cardiac Rehab Program typically experience a
 waiting period of 3 weeks, or sometimes more, before starting the program.
 
 Secondary aims of the proposed study are to evaluate the effect of HT on CR program outcome
 measures of METs, BMI, physical and mental well-being, and attendance in this population.
 
 New participants in the CR program who qualify and agree to participate in the study will be
 consented and randomly assigned to the Intervention Group who will receive Healing Touch
 therapy, or to the Control Group, which will not receive HT.
 
 At baseline both groups will complete the Dartmouth Quality of Life and SF-36 Health Surveys.
 The questionnaires will be repeated at the end of the 3 week study period and at the end of
 the 3 months SCIM CR program.
 
 An effect size of 15% was chosen, with an alpha level of 0.05, 80% power, 95% confidence
 level, and using a two-tailed test, it was determined that a sample size of 56 patients in
 each group would be needed for between group comparisons. To account for potential attrition
 the study will enroll 124 subjects, 62 in each group.
 
 Our rationale is that Healing Touch, in addition to standard medical care will reduce
 post-cardiac event stress and anxiety symptoms in patients waiting to enter a cardiac rehab
 program, as measured by the Dartmouth Quality of Life Index and the SF36 questionnaire.
 Further, the investigators suggest that Healing Touch treatments will improve patient's final
 outcomes of the 12 week CR program.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT02695134
Non-Device Trial