Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension
|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: NCT03194438|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment|
|Pulmonary Hypertension Chronic Disease||Behavioral: Urban Zen Integrative Therapy (UZIT)|
This feasibility and acceptability study will use a pre/post intervention (6-weeks UZIT program) mixed-method design with repeated (weekly) measures of a single cohort of 20 patients with PH. This study will also explore preliminary efficacy testing to construct sample size estimates for future randomized control trials. Patients will serve as their controls.
This study will enroll 20 patients from two PH clinics within the Ohio State University Wexner Medical Center (OSUWMC). Patients with PH condition related to the cardiac cause are managed at the OSU Cardiology clinic located at the Ross Heart Hospital. Patients with PH condition related to other causes are managed at the OSU Pulmonary clinic at Martha Morehouse. These inter-professional clinics provide access to a patient population with diverse race/ ethnicity, sex, and age. All eligible patients managed at both PH clinics at OSUWMC will be invited to participate. Patients in both clinics receive standard medical treatments according to institutional and national clinical practice guidelines.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single cohort of sample with repeated measure assessment of symptoms.|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Acceptability of an Integrative Therapy for Symptom Management in Persons With Pulmonary Hypertension|
|Actual Study Start Date :||June 19, 2017|
|Estimated Primary Completion Date :||May 1, 2018|
|Estimated Study Completion Date :||June 1, 2018|
Experimental: UZIT arm
Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy.
Behavioral: Urban Zen Integrative Therapy (UZIT)
Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki.
- Pulmonary Arterial Hypertension Symptom Scale [ Time Frame: 12 months ]Symptoms assessment and Health related quality of life assessment.
- Cambridge Pulmonary Hypertension Outcome Review [ Time Frame: 12 months ]Symptoms assessment and Health related quality of life assessment.
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): NCT03194438
|United States, Ohio|
|The Ohio State University Ross Heart Hospital||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Tania VonVisger, PhD 614-293-0482 firstname.lastname@example.org|