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Completed

NCT Number: NCT03194438

Urban Zen Integrative Therapy for 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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Chronic Disease Disease Attributes Hypertension Hypertension, Pulmonary Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Ross Heart Hospital

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

are:

  • confirmed diagnosis of PH in the past 1 year,
  • age > 18 years, (children typically have different etiologies, and often require parent involvement in symptom management),
  • ability to ambulate independently,
  • New York Heart Association functional classification II/III, and
  • willingness to participate in the entire 6-8 weeks study.

Exclusion criteria

are

  • known allergies to essential oils (lavender, lemon, or peppermint),
  • Asthma condition,
  • psychiatric illness requiring hospitalization within the last year per self-report or medical record,
  • self-reported pregnancy,
  • on-going participation in mind-body integrative therapy, and
  • inability to read/write English (to complete questionnaires).

Treatment and study plan

Urban Zen Integrative Therapy (UZIT)

Behavioral

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

Primary outcomes

  1. Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion

    Time frame: Baseline and 6-week post-intervention

    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

Secondary outcomes

  1. Change in Cambridge Pulmonary Hypertension Outcome Review.

    Time frame: Baseline and 6-week post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2017
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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