Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension
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Details and patient eligibility
About
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.
Full 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.
Enrollment
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Inclusion and exclusion criteria
Inclusion criteria are:
- confirmed diagnosis of PH in the past 1 year,
- age > 18 years, (children typically have different etiologies, and often require parent involvement in symptom management),
- ability to ambulate independently,
- New York Heart Association functional classification II/III, and
- willingness to participate in the entire 6-8 weeks study.
Exclusion criteria are
- known allergies to essential oils (lavender, lemon, or peppermint),
- Asthma condition,
- psychiatric illness requiring hospitalization within the last year per self-report or medical record,
- self-reported pregnancy,
- on-going participation in mind-body integrative therapy, and
- inability to read/write English (to complete questionnaires).
Trial design
Primary purpose
Allocation
Interventional model
Masking
14 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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