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

NCT06787859 | Active Not Recruiting

• 1 other identifier: DICLE-ARDASURUCU-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus 2; Insulin Dependent Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, insulin, fear, pain,; curtain; Self-Injection

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale -VAS

  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.

  Before insulin administration on day one Time Frame: After two insulin administration on the second day

Secondary Outcomes (1)

• 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

Study Arms (2)

the experimental groups

EXPERIMENTAL

Nature-content "Curtain" will be shown before and during insulin injection administration

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

Nature-content "Curtain" Free

NO INTERVENTION

patients without of experimental Nature-content "Curtain"

Interventions

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

a nature view curtain

the experimental groups

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle Univertsity

Diyarbakır, South East, 21100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Noninsulin-Dependent, 2; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Insulin Resistance; Pain

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: They do not know the experimental or control procedures that take place
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: study group and control group

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 22, 2025
• Study Start: January 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)