Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Feasibility and Acceptability of an Integrative Therapy for Symptom Management in Persons With Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194438
• Other study ID #: 2017H0022
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: June 5, 2018

Study information

• Verified date: June 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 5, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Disease
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University Ross Heart Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Arterial Hypertension Symptom Scale	Symptoms assessment and Health related quality of life assessment.	12 months
Secondary	Cambridge Pulmonary Hypertension Outcome Review	Symptoms assessment and Health related quality of life assessment.	12 months