Healing Touch Prior to Cardiac Rehab
Healing Touch Intervention in Post-Cardiac Event Patients Prior to Starting a Cardiac Rehab Program
1 other identifier
interventional
124
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJuly 21, 2017
July 1, 2017
2.8 years
February 23, 2016
July 19, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants with an improvement in stress and anxiety symptoms as measured by Dartmouth Quality of Life Index scores
Dartmouth Quality of Life Index questionnaires will be obtained at enrollment and after 3 weeks of HT (or no intervention for the control group).
3 weeks
Number of participants with an improvement in stress and anxiety symptoms as measured by SF-36 scores
SF-36 questionnaires will be obtained at enrollment and after 3 weeks of HT (or no intervention for the control group).
3 weeks
Secondary Outcomes (5)
Number of participants with an improvement of Metabolic Equivalent of Task (MET)
3 months
Number of participants with an improvement in BMI: Body Mass Index
3 months
Number of participants with an improvement in stress and anxiety symptoms as measured by Dartmouth Quality of Life Index scores
3 months
Number of cardiac rehab sessions each participant attended will be recorded
3 months
Number of participants with an improvement in stress and anxiety symptoms as measured by SF-36 scores
3 months
Study Arms (2)
Intervention Group
OTHERThis group will receive 6 Healing Touch treatments over 3 weeks
Control Group[
NO INTERVENTIONThis group will continue with their usual medical treatments but receive NO Healing Touch
Interventions
Healing Touch (HT) is an energy based approach to health and healing. It uses light touch to influence the energy field that surrounds the body, and energy centers which control the flow of energy to the physical body.
Eligibility Criteria
You may qualify if:
- Must have referral to Cardiac Rehab at the Scripps Center for Integrative Medicine.
- Must have had a cardiac event which precede the CR referral.
- Must be willing to come to the Scripps Center for Integrative Medicine twice a week for 3 weeks.
- Must be able to understand English
You may not qualify if:
- Patients under 18 years.
- Unable to understand English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scripps Healthlead
Study Sites (1)
Scripps Center for Integrative Medicine
La Jolla, California, 92037, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Suhar, MD
Scripps Center for Integrative Medicine, Scripps Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2016
First Posted
March 1, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2018
Study Completion
June 1, 2019
Last Updated
July 21, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share