Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension

NCT ID: NCT03194438

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-19
• Study Completion Date: 2018-06-05

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.

Conditions

Pulmonary Hypertension; Chronic Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UZIT arm

Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy.

Group Type: EXPERIMENTAL

Urban Zen Integrative Therapy (UZIT)

Intervention Type: BEHAVIORAL

Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki.

Interventions

Urban Zen Integrative Therapy (UZIT)

Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tania VonVisger, PhD

Role: PRINCIPAL_INVESTIGATOR

SUNY Buffalo

Locations

The Ohio State University Ross Heart Hospital

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33246388 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31644380 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017H0022

Identifier Type: -

Identifier Source: org_study_id