Recruiting

Healing Touch

Sponsor:

Scripps Health

Code:

NCT02695134

Conditions

Heart Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Healing Touch

Study Details

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.

Conditions

Heart Disease

Study ID

NCT02695134

Start date

Feb, 2016

Status verified date

Jul, 2017

Completion date

Jun, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Must have referral to Cardiac Rehab at the Scripps Center for Integrative Medicine.
2. Must have had a cardiac event which precede the CR referral.
3. Must be willing to come to the Scripps Center for Integrative Medicine twice a week for 3 weeks.
4. Must be able to understand English

Exclusion Criteria:

1. Patients under 18 years.
2. Unable to understand English

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Intervention Group

This group will receive 6 Healing Touch treatments over 3 weeks

no intervention: Control Group[

This group will continue with their usual medical treatments but receive NO Healing Touch

Interventions

Healing Touch

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.

Primary outcome measure

  • Number of participants with an improvement in stress and anxiety symptoms as measured by Dartmouth Quality of Life Index scores [ Time Frame: 3 weeks ]
  • Number of participants with an improvement in stress and anxiety symptoms as measured by SF-36 scores [ Time Frame: 3 weeks ]

Central Contacts and Locations

Locations

Scripps Center for Integrative Medicine

Recruiting

La Jolla, California, United States, 92037

Contacts

More Information

Sponsor

Scripps Health

Last update posted

Jul 21, 2017

Last verified

Jul, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Health on 2017-07-21.