Clinical trial NCT03194438: Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension
Official title: Feasibility and Acceptability of an Integrative Therapy for Symptom Management in Persons With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Chronic Disease
Keywords: Pulmonary Hypertension
Symptom Management
Behavioral Intervention
Integrative Therapy
Quality of Life
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single cohort of sample with repeated measure assessment of symptoms.
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion
timeFrame: Baseline and 6-week post-intervention
Secondary outcomes:
measure: Change in Cambridge Pulmonary Hypertension Outcome Review.
timeFrame: Baseline and 6-week post-intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Ross Heart Hospital
state: Ohio
Study officials:
affiliation: SUNY Buffalo
name: Tania VonVisger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Von Visger TT, Thrane SE, Klatt MD, Chang YP, Happ M. Deep Relaxation Experience with Complementary Urban Zen Integrative Therapy: Qualitative Thematic Analysis. West J Nurs Res. 2021 Aug;43(8):723-731. doi: 10.1177/0193945920973941. Epub 2020 Nov 27.
citation: Von Visger TT, Thrane SE, Klatt MD, Dabbs AD, 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. 2020 May;23(5):703-711. doi: 10.1089/jpm.2019.0359. Epub 2019 Oct 31.