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

NCT ID: NCT06519903

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-12-31

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.

Conditions

Type 2 Diabetes; Type 2 Diabetes Treated With Insulin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

BREATH Intervention Group

During initial meeting before randomization, all patients was administered the SUDS, STAI-I, and STAI-II scales by another clinical nurse. Following this, patients were taken to a quiet, well-ventilated, and well-lit room for the BREATH breathing technique session. Following a brief training session, the BREATH technique was applied in individual sessions lasting approximately 24 min. The post-test SUDS, STAI-I, and STAI-II scales were administered by the clinical nurse.

Group Type: ACTIVE_COMPARATOR

BREATH technique

Intervention Type: BEHAVIORAL

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.

Control Group

Patients in the control group were administered the Demographic Information Form, SUD, STAI-I, and STAI-II as a pre-test. No intervention was administered in the control group. After the pre-test, the patient was placed in a quiet, well-ventilated, and well-lit room for 24 minutes. Subsequently, the SUD, STAI-I, and STAI-II scales were administered as post-tests.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BREATH 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goztepe Prof Dr Suleyman Yalcın City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ayse N Erbakan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayse N Erbakan

Role: PRINCIPAL_INVESTIGATOR

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Locations

SB Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Breath Study

Identifier Type: -

Identifier Source: org_study_id