Pulmonary HypertensionNCT03194438
Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension
A study testing Urban Zen Integrative Therapy (UZIT) in people with Pulmonary Hypertension and Chronic Disease, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Chronic Disease
- What is being tested?
- Urban Zen Integrative Therapy (UZIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 5 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Ross Heart Hospital
Columbus, Ohio, 43210
About this study
Official title: Feasibility and Acceptability of an Integrative Therapy for Symptom Management in 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.
Read the 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
- Being tested
- Urban Zen Integrative Therapy (UZIT)
- Keywords
- Pulmonary Hypertension, Symptom Management, Behavioral Intervention, Integrative Therapy, Quality of Life
- Medical subject headings
- Hypertension, Pulmonary, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urban Zen Integrative Therapy (UZIT)Behavioural
Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki.
| Study group | Role | What they receive |
|---|---|---|
| UZIT arm | Experimental | Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy. Receives: Behavioral: Urban Zen Integrative Therapy (UZIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6-week post-intervention
Secondary outcomes (1)
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.
Measured: Baseline and 6-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start19 Jun 2017
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single cohort of sample with repeated measure assessment of symptoms.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tania VonVisger, PhD, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194438
- Sponsor's protocol ID
- 2017H0022
- Status last verified
- Apr 2024
- First submitted
- 15 Jun 2017
- Last updated
- 3 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33246388Von 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.
PubMed 31644380
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of an Integrative Therapy for Symptom Management in Persons With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03194438
- Acronym / sponsor ID
- 2017H0022
- Conditions
- Pulmonary Hypertension, Chronic Disease
- Keywords
- Pulmonary Hypertension, Symptom Management, Behavioral Intervention, Integrative Therapy, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Posted 3 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single cohort of sample with repeated measure assessment of symptoms.
| Arm | Type | Receives |
|---|---|---|
| UZIT arm | Experimental | Behavioral: Urban Zen Integrative Therapy (UZIT)Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urban Zen Integrative Therapy (UZIT)Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki. | Behavioural | UZIT arm |
Primary outcome
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
1 secondary outcome
Change in Cambridge Pulmonary Hypertension Outcome Review.
Time frame: Baseline and 6-week post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33246388Von 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.
- Derived from this study: PubMed 31644380Von 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania VonVisger, PhD principal investigator
SUNY Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urban Zen Integrative Therapy (UZIT) in people with Pulmonary Hypertension and Chronic Disease, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion (time frame: Baseline and 6-week post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.