Trial Outcomes & Findings for Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension (NCT NCT03194438)

NCT ID: NCT03194438

Last Updated: 2024-09-03

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline and 6-week post-intervention
• Results posted on: 2024-09-03

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	14
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension

Baseline characteristics by cohort

Measure	UZIT Arm n=14 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	58.26 Years STANDARD_DEVIATION 11.07 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized White	11 participants n=5 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic or Latino	13 participants n=5 Participants
Race/Ethnicity, Customized Latino	1 participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants
Pulmonary Arterial Hypertension Symptom Scale - SOB Exertion	6.70 units on a scale STANDARD_DEVIATION 2.26 • n=5 Participants
Cambridge Pulmonary Hypertension Outcome Review - Symptom Burden	12.00 units on a scale STANDARD_DEVIATION 5.24 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	UZIT Arm n=9 Participants 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.
Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion	3.0 units on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	UZIT Arm n=9 Participants 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.
Change in Cambridge Pulmonary Hypertension Outcome Review.	8.91 score on a scale Standard Deviation 5.24

Adverse Events

UZIT Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tania Von Visger, APRN, PhD, PCCN

State University of New York at Buffalo School of Nursing

Phone: 7168292201

Email: Taniavon@buffalo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place