Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04718753
Status:
COMPLETED
Last Update Posted:
2021-08-12
First Post:
2021-01-14
Brief Title:
Mindful Breathing Using EMA and and Actigraphy A Pilot Study
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Positive Spiral of Mindfulness in Mindful Breathing A Pilot Randomized Controlled Trial Using Ecological Momentary Assessment and Actigraphy
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effect of mindful breathing and the mechanism of positive spirals of mindfulness using ecological momentary assessment EMA and actigraphy Previous studies have shown a positive spiral between state mindfulness and positive affect Du An Ding Zhang Xu 2018 The mindful coping model Garland Gaylord Fredrickson 2011 suggested that the state of mindfulness can lead to reappraisal and reframing of their stressful circumstances which further lead to positive emotion and reduced stress These positive effects will affect the next cycle and hence form a positive spiral Since mindful breathing was an effective practice for immediate decentering Feldman Greeson Senville 2010 it will be used as the manipulation of state mindfulness Besides there is very limited research on the associations between these constructs using EMA and actigraphy Therefore this study will explore this association by manipulating the state of mindfulness with mindful breathing using EMA
Detailed Description:
This proposed study will be a randomized control trial which studies the mechanism of positive spirals of mindfulness in mindful breathing Potential participants will be recruited from the community through posters social media sites andor emails About 30 eligible participants will be recruited after an online screening with phone support Prior to all study procedures the research purpose and data collection procedure will be given to the participants and an online informed consent will be obtained from them
In this study participants will be randomly assigned to either the mindful breathing group intervention group or the waitlist group control group in a ratio of 11 The randomization will be performed by an independent assessor using a computer-generated list of numbers No deception is necessary
All participants will be requested to wear an actigraphy device ActiGraph GT9X link connected to a heart rate sensor Polar H10 for 8 consecutive days for recording their physiological data including HRV and activity level Ecological momentary assessment EMA will also be used A smartphone application will be developed and installed in the participants smartphones The app will prompt the participants 4 times each day 9 am 1 pm 5 pm and 9 pm to fill in a self-report questionnaire concerning mood Besides that participants have to complete an assessment at baseline and immediate post-intervention assessments
Participants in treatment group will receive mindful breathing instructions daily at 9 am after completing the EMA questionnaires They will be asked to perform a 10-minute mindful breathing exercise based on an audio After that they will submit a simple record indicating the time they have completed the exercise Meanwhile participants in the waitlist condition will not receive the recording during the study However the same set of mindful breathing instruction audio will be sent to the waitlist group after the study
In this study participants will be randomly assigned to either the mindful breathing group intervention group or the waitlist group control group in a ratio of 11 The randomization will be performed by an independent assessor using a computer-generated list of numbers No deception is necessary
All participants will be requested to wear an actigraphy device ActiGraph GT9X link connected to a heart rate sensor Polar H10 for 8 consecutive days for recording their physiological data including HRV and activity level Ecological momentary assessment EMA will also be used A smartphone application will be developed and installed in the participants smartphones The app will prompt the participants 4 times each day 9 am 1 pm 5 pm and 9 pm to fill in a self-report questionnaire concerning mood Besides that participants have to complete an assessment at baseline and immediate post-intervention assessments
Participants in treatment group will receive mindful breathing instructions daily at 9 am after completing the EMA questionnaires They will be asked to perform a 10-minute mindful breathing exercise based on an audio After that they will submit a simple record indicating the time they have completed the exercise Meanwhile participants in the waitlist condition will not receive the recording during the study However the same set of mindful breathing instruction audio will be sent to the waitlist group after the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None