Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/14/2018 |
| Start Date: | June 19, 2017 |
| End Date: | June 5, 2018 |
Feasibility and Acceptability of an Integrative Therapy for Symptom Management in Persons With Pulmonary Hypertension
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.
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.
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.
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.
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).
We found this trial at
1
site
452 West 10th Avenue
Columbus, Ohio 43210
Columbus, Ohio 43210
Phone: 614-293-0482
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