Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension
Primary Purpose
Pulmonary Hypertension, Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Urban Zen Integrative Therapy (UZIT)
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Hypertension, Symptom Management, Behavioral Intervention, Integrative Therapy, Quality of Life
Eligibility Criteria
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).
Sites / Locations
- The Ohio State University Ross Heart Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UZIT arm
Arm Description
Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy.
Outcomes
Primary Outcome Measures
Pulmonary Arterial Hypertension Symptom Scale
Symptoms assessment and Health related quality of life assessment.
Secondary Outcome Measures
Cambridge Pulmonary Hypertension Outcome Review
Symptoms assessment and Health related quality of life assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03194438
Brief Title
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
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Chronic Disease
Keywords
Pulmonary Hypertension, Symptom Management, Behavioral Intervention, Integrative Therapy, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single cohort of sample with repeated measure assessment of symptoms.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UZIT arm
Arm Type
Experimental
Arm Description
Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy.
Intervention Type
Behavioral
Intervention Name(s)
Urban Zen Integrative Therapy (UZIT)
Intervention Description
Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki.
Primary Outcome Measure Information:
Title
Pulmonary Arterial Hypertension Symptom Scale
Description
Symptoms assessment and Health related quality of life assessment.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cambridge Pulmonary Hypertension Outcome Review
Description
Symptoms assessment and Health related quality of life assessment.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
The Ohio State University Ross Heart Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33246388
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.
Results Reference
derived
PubMed Identifier
31644380
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.
Results Reference
derived
Learn more about this trial
Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension
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