Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UZIT arm | Experimental | Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
Not provided
Inclusion criteria are:
Exclusion criteria are
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tania VonVisger, PhD | SUNY Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Ross Heart Hospital | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33246388 | Derived | 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. | |
| 31644380 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | UZIT Arm | Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy. Urban Zen Integrative Therapy (UZIT): Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | UZIT Arm | Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy. Urban Zen Integrative Therapy (UZIT): Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6-week post-intervention |
|
Each participant spent 6 weeks in the study, adverse event data were collected over that 6 week period.
The definition of adverse event and/or serious adverse event used did not differ from the clinicaltrials.gov definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UZIT Arm | Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy. Urban Zen Integrative Therapy (UZIT): Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki. |
Not provided
Not provided
The final analysis for PAHSS and CAMPHOR were obtained from 9 participants who completed the entire 6-week intervention and with complete assessment data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tania Von Visger, APRN, PhD, PCCN | State University of New York at Buffalo School of Nursing | 7168292201 | Taniavon@buffalo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2019 | Mar 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 25, 2017 | Mar 27, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
Not provided
Single cohort of sample with repeated measure assessment of symptoms.
Not provided
Not provided
Not provided
Not provided
| Baseline and 6-week post-intervention |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Pulmonary Arterial Hypertension Symptom Scale - SOB Exertion | Measures pulmonary hypertension-related symptom severity. Minimum score 0, maximum score 10, with 10 being the worst outcome. There are no sub-scores in this measure. | Mean | Standard Deviation | units on a scale |
|
| Cambridge Pulmonary Hypertension Outcome Review - Symptom Burden | Measures pulmonary hypertension-related Quality of Life: Sub- scales - Symptom Severity Scale Minimum score 0, maximum score 25, with 25 being the worst outcome. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6-week post-intervention |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |