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

January 16, 2025 updated by: Hamdiye ARDA SÜRÜCÜ, Dicle University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • South East
      • Diyarbakır, South East, Turkey, 21100
        • Dicle Univertsity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the experimental groups
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
a nature view curtain
No Intervention: Nature-content "Curtain" Free
patients without of experimental Nature-content "Curtain"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before insulin administration on day one Time Frame: After two insulin administration on the second day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before insulin administration on day one Time Frame: After two insulin administration on the second day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dicle University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DICLE-ARDASURUCU-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Dependent Diabetes Mellitus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe