Investigation of the Effect of "Curtain" Use on Self-Injection, Testing Fear and Pain in Patients With Type 2 Diabetes

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes Mellitus 2; Insulin Dependent Diabetes Mellitus

• Registration Number: NCT06787859
• Lead Sponsor: Dicle University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-12-27
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Type 2 diabetes for at least one year
• self-administering insulin injections
• self-administering a glucometer, insulin pen or insulin pump,

Exclusion Criteria

• poor mental health
• Having gestational diabetes mellitus or Type 1 Diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale -VAS	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.

Secondary Outcome Measures

Name	Time	Method
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	The D-FISQ consists of two subscales: fear of self-injection (fear of self-injecting-FSI, 6 statements) and fear of self-testing (fear of self-testingFST, 9 statements). Each statement has a four-point Likert-type scale ranging from 0 to 3 (0= almost never, 1= sometimes, 2= often, 3= almost always). The evaluation of the questionnaire can be done by taking the average or raw score for the two sub-dimensions and the whole questionnaire. When taken as raw score, self-injection fear score ranges between 0-18, self-testing fear score ranges between 0-27, and total fear score ranges between 0-45. An increase in score indicates an increase in fear.; It will be administered before and after each insulin injection. Each patient will be administered three times.

Trial Locations

Locations (1)

Dicle Univertsity; 🇹🇷 Diyarbakır, South East, Turkey