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临床试验/NCT06519903
NCT06519903已完成不适用

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

Goztepe Prof Dr Suleyman Yalcın City Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of distress

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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,

排除标准

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

研究组 & 干预措施

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.

干预措施: BREATH technique (Behavioral)

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.

结局指标

主要结局

the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of distress

时间窗: 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 axiety state

时间窗: 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.

the impact of breathing exercises on anxiety levels during the first insulin injection in patients with type 2 diabetes, the evaluation of current anxiety

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Goztepe Prof Dr Suleyman Yalcın City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse N Erbakan

Principal Investigator

Goztepe Prof Dr Suleyman Yalcın City Hospital

研究点 (1)

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