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Anxiety Reduction in Type 2 Diabetes Through Breathing ExercisesPatients With Type 2 Diabetes

The Impact of Breathing Exercises on Anxiety Levels During the First Insulin Injection in Patients With Type 2 Diabetes-the BREATH Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06519903
Enrollment
65
Registered
2024-07-25
Start date
2022-05-01
Completion date
2022-12-31
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes, Type 2 Diabetes Treated With Insulin

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.

Interventions

BEHAVIORALBREATH technique

The BREATH techniques include deep breathing, rapid breathing, and alternate nostril breathing exercises. 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.

Sponsors

Goztepe Prof Dr Suleyman Yalcın City Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* type 2 diabetes diagnosis for at least one year, * followed up at the diabetes outpatient clinic, * literate and able to understand and complete study forms, * first-time insulin injectors in addition to oral antidiabetics,

Exclusion criteria

* younger than 18 years * older than 65 years * having visual, auditory, or mental impairments that would affect to complete the forms

Design outcomes

Primary

MeasureTime frameDescription
the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of distressthirty minutesAnxiety levels were determined by Subjective Units of Disturbance Scale test. The Subjective Units of Disturbance Scale (SUDS) is a self-report measure developed by Joseph Wolpe to quantify an individual's level of distress. The scale ranges from 0 to 10, where * 0 represents no distress or disturbance. * 10 represents the highest level of imaginable distress or disturbance.
the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of current anxietythirty minutesAnxiety levels were determined by State Anxiety Inventory tests The State Anxiety Inventory is a widely used self-report questionnaire designed to assess the current state of anxiety, distinguishing it from trait anxiety (which is more about general anxiety tendencies). The total score ranges from 20 to 80, with higher scores indicating higher state anxiety levels.
the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of axiety statethirty minutesThe Trait Anxiety Inventory is part of the State-Trait Anxiety Inventory and specifically measures trait anxiety, which refers to relatively stable individual differences in anxiety proneness and the tendency to perceive stressful situations as threatening.The total score ranges from 20 to 80, with higher scores indicating higher trait anxiety levels.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026