Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease; Pulmonary Hypertension
• Intervention / Treatment: Behavioral: Urban Zen Integrative Therapy (UZIT)

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Ross Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UZIT arm; Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion	Symptoms assessment and Health-related quality of life assessment. We focused on the shortness of breath. The minimum and maximum scores are 0 and 10, respectively. A higher score indicates the worst outcome.Measured at baseline and 6-weeks post-intervention for comparision	Baseline and 6-week post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cambridge Pulmonary Hypertension Outcome Review.	This instrument was used to measure the overall Health-related quality of life with multiple domains. We focused on the Symptom Burden domain. The minimum and maximum scores range from "0" to "25", indicating "good" and "poor" symptom burden, respectively. The scale of the change score indicates the level of MID (minimum importance difference). If the score is more significant than 2.0 MID, the intervention makes a minimal level of importance in their quality of life perception. Measurements were taken at baseline and 6-weeks post-intervention for comparision.	Baseline and 6-week post-intervention

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Tania VonVisger, PhD, SUNY Buffalo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): June 5, 2018
• Study Completion (Actual): June 5, 2018

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Pulmonary Hypertension; Behavioral Intervention; Symptom Management; Integrative Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Hypertension; Chronic Disease; Hypertension, Pulmonary
• Other Study ID Numbers: 2017H0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No