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NCT Number: NCT06787859

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus 2 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Noninsulin-Dependent, 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Dependent Diabetes Mellitus Insulin Resistance Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dicle Univertsity

Diyarbakır, South East, 21100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Showing a nature view curtain to type 2 diabetic patients during insulin injection

Other

a nature view curtain

Primary outcomes

  1. Visual Analogue Scale -VAS

    Time frame: 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 outcomes

  1. Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dicle University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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