Mindful Breathing Awareness Through Pursed-Lip Breathing Training
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03198780|
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : October 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Other: Breathing Awareness||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||pilot study|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients|
|Actual Study Start Date :||October 1, 2018|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
Experimental: Breathing Awareness
In the clinic, once patients are proficient with the proposed tool, they will (1) independently don the pulse oximeter, (2) use the prototype to perform the mindful breathing intervention. The whole session will last no longer than 60 minutes with 30 minutes for the consent and demonstrations, two minutes to don the study devices, 15 minutes to practice mindful breathing, and two minutes to doff the study devices. The mindful breathing portion will be divided into three sessions. Each session will last three minutes and display a different presentation of Heart Rate Coherence biofeedback.
At home, after completing the in-clinic study, five patients will take the mindful breathing tool home for a week to practice pursed-lip breathing at least five times. They will don the study devices, perform the intervention, and doff study devices.
Other: Breathing Awareness
Participants will use a pulse-oximeter and biofeedback app to guide them through pursed-lip breathing training.
- Participant assessment of device feasibility [ Time Frame: up to 1 week ]Participants in both arms will complete a subjective questionnaire to elicit information about their experience and opinions about the intervention
- Device Use Assessed by Pulse Oximetry Data [ Time Frame: up to 1 week ]The system will track data on each patient's breathing pattern to assess whether they are following the program
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198780
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Kevin Kramer, Ph.D||Minnesota HealthSolutions|