N/A
N=14
Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension
Pulmonary Hypertension · Chronic Disease
Bottom Line
View on ClinicalTrials.gov: NCT03194438 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion — 3.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Urban Zen Integrative Therapy (UZIT) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion |
3.0 | — |
| SECONDARY Change in Cambridge Pulmonary Hypertension Outcome Review. |
8.91 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT03194438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.