Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510907
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
MBSR on Nocturnal Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Acceptability of Mindfulness-based Stress Reduction Program on Patients With Nocturnal Hypertension A Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives To examine the feasibility and acceptability of treating nocturnal hypertension by mindfulness-based stress reduction program MBSR This will provide data essential for the main trial which will also examine the definite effectiveness of MBSR to reduce nocturnal blood pressure BP
Hypothesis to be tested MBSR and the current trial are acceptable and safe to patients with nocturnal hypertension and future main trial is feasible in terms of recruitment dropout rate and adherence to MBSRBP measurements
Design and subjects This pilot randomized-controlled trial will recruit 76 patients with nocturnal HT night-time Systolic BP SBP during sleep 120 mmHg and stage I hypertension awake SBP 135-159mmHg as detected by ambulatory blood pressure monitoring ABPM Participants will be allocated in 11 ratio by stratified block randomization by age and presence of mood disorder to receive MBSR intervention group or usual care control group respectively
Instruments ABPMHBPMMBSR patients diary Interventions The generic 8-week MBSR will be taught by a certified MBSR teacher Participants in MBSR arm will be asked to meditate 40 minutes every day during the interventional period
Main outcome measures rate of recruitmentdropoutadherence to MBSRBP measurements Data analysis and expected results The rate of recruitmentdropoutadherence to MBSRBP measurements will be presented
The acceptability of MBSR and the trial will also be assessed by patients interviews A high level of rate of recruitment adherence to both MBSR and BP measurements and acceptability to MBSR are expected
Hypothesis to be tested MBSR and the current trial are acceptable and safe to patients with nocturnal hypertension and future main trial is feasible in terms of recruitment dropout rate and adherence to MBSRBP measurements
Design and subjects This pilot randomized-controlled trial will recruit 76 patients with nocturnal HT night-time Systolic BP SBP during sleep 120 mmHg and stage I hypertension awake SBP 135-159mmHg as detected by ambulatory blood pressure monitoring ABPM Participants will be allocated in 11 ratio by stratified block randomization by age and presence of mood disorder to receive MBSR intervention group or usual care control group respectively
Instruments ABPMHBPMMBSR patients diary Interventions The generic 8-week MBSR will be taught by a certified MBSR teacher Participants in MBSR arm will be asked to meditate 40 minutes every day during the interventional period
Main outcome measures rate of recruitmentdropoutadherence to MBSRBP measurements Data analysis and expected results The rate of recruitmentdropoutadherence to MBSRBP measurements will be presented
The acceptability of MBSR and the trial will also be assessed by patients interviews A high level of rate of recruitment adherence to both MBSR and BP measurements and acceptability to MBSR are expected
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None