Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519903
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Anxiety Reduction in Type 2 Diabetes Through Breathing ExercisesPatients With Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Breathing Exercises on Anxiety Levels During the First Insulin Injection in Patients With Type 2 Diabetes-the BREATH Study
Status:
COMPLETED
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:
Injection-related anxiety is a significant barrier to the management of type 2 diabetes adversely affecting treatment adherence and glycemic control This study investigated the effectiveness of breathing exercises in reducing anxiety during the first insulin injection
Detailed Description:
This study is designed as a randomized double-blind experimental study Data from patients who agree to participate in the study was collected by the researcher prior to testing Variables collected include age gender marital status education level occupation body mass index BMI HbA1c levels and diabetes duration as well as scores on the Subjective Disorders Scale SUDS State Anxiety Inventory STAI-I and Trait Anxiety Inventory STAI-II Patients were then randomly assigned to the intervention BREATH and control groups using a computer-generated randomization table Allocation continued until the blocks in each group are equal in size
Participants in the BREATH and control groups was identified prior to the intervention All participants completed a form with demographic information The participants in the control group completed the SUDS STAI-I and Trait Anxiety Inventory STAI-II scales before the test They then had 30 minutes of free time The SUDS STAI-I and STAI-II scales were then completed for the post-test
In the BREATH intervention group participants were first instructed on the breathing exercises at the lowest point of breathing close the left nostril with the right index finger and exhale through the right nostril Breathe in through the right nostril then close it with your thumb and breathe out through the left nostril This cycle was repeated at least three more times Participants completed the SUDS STAI-I and STAI-II scales before the test following by a single BREATH session approximately 30 minutes After the test the SUDS STAI-I and STAI-II were administered
Standard treatment for all patients was not interrupted during the study Appointments for the randomized patients were made by telephone to avoid encounters and mutual interference between the groups
Participants in the BREATH and control groups was identified prior to the intervention All participants completed a form with demographic information The participants in the control group completed the SUDS STAI-I and Trait Anxiety Inventory STAI-II scales before the test They then had 30 minutes of free time The SUDS STAI-I and STAI-II scales were then completed for the post-test
In the BREATH intervention group participants were first instructed on the breathing exercises at the lowest point of breathing close the left nostril with the right index finger and exhale through the right nostril Breathe in through the right nostril then close it with your thumb and breathe out through the left nostril This cycle was repeated at least three more times Participants completed the SUDS STAI-I and STAI-II scales before the test following by a single BREATH session approximately 30 minutes After the test the SUDS STAI-I and STAI-II were administered
Standard treatment for all patients was not interrupted during the study Appointments for the randomized patients were made by telephone to avoid encounters and mutual interference between the groups
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