Investigation of the Effect of "Curtain" Use on Self-Injection, Testing Fear and Pain in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale -VAS
研究概览
简要总结
Diabetes is a global problem for the world and negatively affects life (1). The most important reasons for ineffective diabetes and insulin treatment include fear of insulin side effects, fear of insulin injection, social embarrassment from administering insulin, fear of hypoglycemia and/or hyperglycemia (2). A large portion of diabetic individuals experience these fears, and some of these patients cope with these fears and integrate them into their daily lifestyles. However, some diabetic patients may be ineffective in coping with these fears (3). This situation creates negativities in the individual's success in treatment and compliance with treatment (3). Diverting attention is one of the non-pharmacological methods used in pain control. Diverting attention is one of the most preferred methods in reducing the pain experienced by patients during diagnosis and treatment procedures. It is a method that allows patients to control and reduce their symptoms by focusing their attention on a different point (4). In this study, the use of a distracting curtain during self-injection in individuals with Type 2 diabetes will be examined in order to examine the effect of pain and fear.
详细描述
Research Type:
It is designed as a randomized controlled, regular research.
Research Universe and Samples:
The research groups will be the living diabetes cells of Dicle University Hospitals. The research aims to create 100 healthy diabetes patients in Dicle University Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
They do not know the experimental or control procedures that take place
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least one year
- •self-administering insulin injections
- •self-administering a glucometer, insulin pen or insulin pump,
排除标准
- •poor mental health
- •Having gestational diabetes mellitus or Type 1 Diabetes
研究组 & 干预措施
Nature Image Exposure Group
On Day 1, participants underwent routine self-monitoring of blood glucose and insulin injection without any intervention, and baseline measurements were obtained. On Day 2, participants viewed a standardized, high-resolution nature-themed visual displayed on a fixed wall-mounted screen for 3-5 minutes immediately before self-monitoring of blood glucose and insulin injection. Post-intervention measurements were then obtained using the same instruments.
干预措施: Nature Image Exposure (Behavioral)
Standard Care Control Group
Participants received standard care without nature image exposure. On Day 1, baseline measurements were obtained following routine self-monitoring of blood glucose and insulin injection. On Day 2, participants continued routine self-monitoring of blood glucose and insulin injection without any visual intervention, after which post-test measurements were obtained using the same instruments.
结局指标
主要结局
Visual Analogue Scale -VAS
时间窗: Before insulin administration on day one Time Frame: After two insulin administration on the second day
The VAS scale is used to assess subjectively perceived pain. The VAS scale is a 10 cm (100 mm) ruler with no pain at one end and "the most severe pain" at the other end. The individuals participating in the study were asked to mark the intensity of the pain they felt at that moment by explaining that the number "0" on the scale means "I do not feel any pain" and that the pain intensity increases as the numbers increase and that the number "10" means "I feel the most severe pain". In the evaluation, an increase in the score obtained from the scale indicates an increase in pain. It will be administered before and after each insulin injection. Each patient will be administered three times.
Change in Pain Intensity Assessed Using the Visual Analog Scale (VAS)
时间窗: Baseline on Day 1 and post-intervention on Day 2, over two consecutive days
Pain intensity associated with self-monitoring of blood glucose and insulin injection was assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm (100-mm) horizontal line anchored by "no pain" at one end and "worst imaginable pain" at the other end. Participants marked the point that best represented their current pain intensity. Scores range from 0 to 10, with higher scores indicating greater pain intensity. Baseline pain was assessed on Day 1 following routine self-monitoring of blood glucose and insulin injection without any intervention. Post-intervention pain was assessed on Day 2 following nature image exposure and the procedures in the intervention group or following the same procedures under standard care in the control group.
次要结局
- Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ(Before insulin administration on day one Time Frame: After two insulin administration on the second day)
- Change in Fear of Self-Injection and Self-Testing Assessed Using the D-FISQ(Baseline on Day 1 and post-intervention on Day 2, over two consecutive days)
研究者
Hamdiye ARDA SÜRÜCÜ
Professor
Dicle University