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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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 15, 2017
First Posted Date  ICMJE June 21, 2017
Last Update Posted Date June 12, 2018
Actual Study Start Date  ICMJE June 19, 2017
Actual Primary Completion Date June 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
Pulmonary Arterial Hypertension Symptom Scale [ Time Frame: 12 months ]
Symptoms assessment and Health related quality of life assessment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03194438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
Cambridge Pulmonary Hypertension Outcome Review [ Time Frame: 12 months ]
Symptoms assessment and Health related quality of life assessment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension
Official Title  ICMJE Feasibility and Acceptability of an Integrative Therapy for Symptom Management in Persons With Pulmonary Hypertension
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Pulmonary Hypertension
  • Chronic Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: UZIT arm
Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy.
Intervention: Behavioral: Urban Zen Integrative Therapy (UZIT)
Publications * Von Visger TT, Thrane SE, Klatt MD, DeVito Dabbs A, Chlan LL, Tan A, Happ MB. The Impact of Urban Zen Integrative Therapy on Symptoms and Health-Related Quality of Life for Patients with Pulmonary Hypertension. J Palliat Med. 2019 Oct 31. doi: 10.1089/jpm.2019.0359. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2018)
14
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2017)
20
Actual Study Completion Date  ICMJE June 5, 2018
Actual Primary Completion Date June 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03194438
Other Study ID Numbers  ICMJE 2017H0022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ohio State University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP