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Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03194438
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ohio State University

Brief Summary:
The primary goal of this study is to determine the feasibility and acceptability of a 6-week multicomponent integrative therapy program, Urban Zen Integrative Therapy (UZIT), for adults with chronic, life-limiting cardiopulmonary disease. The secondary goal is to determine preliminary efficacy of UZIT in symptom management. Pulmonary hypertension (PH) presents an excellent model of a severe, life-limiting cardiopulmonary condition with high symptom burden and poor outcomes suitable for this scientific inquiry. Despite medical and pharmacological advances in the treatment, 50-55% of persons with PH will die within three years after diagnosis. Medical management often involves life-long complex pharmacological treatment requiring high levels of skill, knowledge, and social support. Clusters of bothersome symptoms such as chest pain, anxiety, insomnia, dyspnea, and fatigue can overwhelm patients' ability to manage daily activities and medication treatment regimens. Side effects of treatment induce additional noxious symptoms. The high prevalence of physical symptoms, depression, and anxiety among adults with PH confirmed in our prior work, can also lead to reduced (HRQoL). A literature search found no published report of complementary, integrative therapy interventions to alleviate symptoms in adults with PH. This study will use a single group repeated-measures design to address the feasibility and acceptability of the intervention and to explore preliminary efficacy.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Chronic Disease Behavioral: Urban Zen Integrative Therapy (UZIT) Not Applicable

Detailed Description:

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)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single cohort of sample with repeated measure assessment of symptoms.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Acceptability of an Integrative Therapy for Symptom Management in Persons With Pulmonary Hypertension
Actual Study Start Date : June 19, 2017
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Pulmonary Arterial Hypertension Symptom Scale [ Time Frame: 12 months ]
    Symptoms assessment and Health related quality of life assessment.


Secondary Outcome Measures :
  1. Cambridge Pulmonary Hypertension Outcome Review [ Time Frame: 12 months ]
    Symptoms assessment and Health related quality of life assessment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria are:

  1. confirmed diagnosis of PH in the past 1 year,
  2. age > 18 years, (children typically have different etiologies, and often require parent involvement in symptom management),
  3. ability to ambulate independently,
  4. New York Heart Association functional classification II/III, and
  5. willingness to participate in the entire 6-8 weeks study.

Exclusion criteria are

  1. known allergies to essential oils (lavender, lemon, or peppermint),
  2. Asthma condition,
  3. psychiatric illness requiring hospitalization within the last year per self-report or medical record,
  4. self-reported pregnancy,
  5. on-going participation in mind-body integrative therapy, and
  6. inability to read/write English (to complete questionnaires).

Information from the National Library of Medicine

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


Locations
United States, Ohio
The Ohio State University Ross Heart Hospital
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University

Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT03194438     History of Changes
Other Study ID Numbers: 2017H0022
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ohio State University:
Pulmonary Hypertension
Symptom Management
Behavioral Intervention
Integrative Therapy
Quality of Life

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Chronic Disease
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes