Chronic Disease, Pulmonary Hypertension
Conditions
Keywords
Pulmonary Hypertension, Symptom Management, Behavioral Intervention, Integrative Therapy, Quality of Life
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.
Interventions
BEHAVIORALUrban Zen Integrative Therapy (UZIT)
Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single cohort of sample with repeated measure assessment of symptoms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Cambridge Pulmonary Hypertension Outcome Review. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | UZIT Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 58.26 Years STANDARD_DEVIATION 11.07 |
| Cambridge Pulmonary Hypertension Outcome Review - Symptom Burden | 12.00 units on a scale STANDARD_DEVIATION 5.24 |
| Pulmonary Arterial Hypertension Symptom Scale - SOB Exertion | 6.70 units on a scale STANDARD_DEVIATION 2.26 |
| Race/Ethnicity, Customized Black | 3 participants |
| Race/Ethnicity, Customized Latino | 1 participants |
| Race/Ethnicity, Customized Non-Hispanic or Latino | 13 participants |
| Race/Ethnicity, Customized White | 11 participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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
Time frame: Baseline and 6-week post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UZIT Arm | Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion | 3.0 units on a scale | Standard Deviation 2.54 |
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.
Time frame: Baseline and 6-week post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UZIT Arm | Change in Cambridge Pulmonary Hypertension Outcome Review. | 8.91 score on a scale | Standard Deviation 5.24 |