Type 2 DiabetesNCT06519903
Anxiety Reduction in Type 2 Diabetes Through Breathing ExercisesPatients With Type 2 Diabetes
A study testing BREATH technique in people with Type 2 Diabetes and Type 2 Diabetes Treated With Insulin, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Type 2 Diabetes Treated With Insulin
- What is being tested?
- BREATH technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- younger than 18 years
- older than 65 years
- having visual, auditory, or mental impairments that would affect to complete the forms
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SB Istanbul Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul
About this study
Official title: The Impact of Breathing Exercises on Anxiety Levels During the First Insulin Injection in Patients With Type 2 Diabetes-the BREATH Study
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.
Read the 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.
- Being tested
- BREATH technique
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREATH techniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BREATH Intervention Group | Active comparator | 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. Receives: Behavioral: BREATH technique |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of distress
Anxiety 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.
Measured: thirty minutes
the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of current anxiety
Anxiety 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.
Measured: thirty minutes
the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of axiety state
The 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.
Measured: thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 May 2022
- Primary completion1 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse N Erbakan, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Ayse N Erbakan, Principal investigator, Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519903
- Sponsor's protocol ID
- Breath Study
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Breathing Exercises on Anxiety Levels During the First Insulin Injection in Patients With Type 2 Diabetes-the BREATH Study
- ClinicalTrials.gov ID
- NCT06519903
- Acronym / sponsor ID
- Breath Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BREATH Intervention Group | Active comparator | Behavioral: BREATH techniqueDuring 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (3 listed)
- younger than 18 years
- older than 65 years
- having visual, auditory, or mental impairments that would affect to complete the forms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREATH techniqueThe 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. | Behavioural | BREATH Intervention Group |
Primary outcome
the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of distress
Time frame: thirty minutes
Anxiety 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 anxiety
Time frame: thirty minutes
Anxiety 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 state
Time frame: thirty minutes
The 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse N Erbakan principal investigator
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREATH technique in people with Type 2 Diabetes and Type 2 Diabetes Treated With Insulin, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of distress (time frame: thirty minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.