Music Effect on the Self-Injection, Testing Fear and Pain

January 24, 2025 updated by: Hamdiye ARDA SÜRÜCÜ, Dicle University

Examination of Music's Demonstration to Self-Injection, Fear of Testing and Pain in Patients With Type 2 Diabetes

Diabetes is a chronic and broad-spectrum metabolic disorder characterized by hyperglycemia that occurs due to relative or absolute insulin deficiency or "insulin resistance" developed against insulin action in peripheral tissues, affecting many organs and causing multisystem involvement. Metabolic function continues to deteriorate after diagnosis, leading to worsening glycemic control and insulin therapy becoming necessary. However, patients may have difficulty adhering to insulin therapy. Fears about injections are common in both adults and children and, as research shows, are a major reason why people with diabetes avoid taking insulin. Addressing these fears is an important part of helping patients reduce their risk of diabetes-related complications. Helping patients manage their replacement pain may help reduce the effects of needle fear in the future. There are a number of strategies that can ease the pain.The use of music in pain management has advantages such as being reliable, cheap, and having no side effects, as well as reducing postoperative pain reports. Music distracts the individual from negative stimuli and allows them to focus on something they enjoy, thus reducing pain and anxiety. Music therapy has also been shown to have sedative-protective effects and reduce stress hormone levels. Listening to preferred music can distract and reduce the pain and negative emotions associated with an unpleasant experience.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Research Type:

The research will be conducted as a randomized controlled experimental model.

Research Universe and Sample:

The research sample will consist of patients diagnosed with Type 2 Diabetes hospitalized in a State Hospital. The sample of the research is expected to consist of 100 volunteer Type 2 Diabetes patients who applied to the State 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 injection
  • Self-administering glucometer, insulin pen or insulin pump

Exclusion Criteria:

  • poor mental health
  • Having gestational diabetes mellitus or Type 1 diabetes
  • no hearing problems

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: Music group
Music will be played during the insulin injection process
Other: Music Therapy
Music will be played during the insulin injection process
No Intervention: Control group (Music free)
patients without of experimental Music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: Before insulin administration on day, Time Frame: After two insulin administration on the second day
The scale is used to assess subjectively perceived pain. It is a 10 cm (100 mm) ruler with no pain on one end and the "most severe pain" on the other. The individuals participating in the study are asked to mark the intensity of pain they are currently feeling, explaining that the number "0" on the scale means "I feel no pain" and that the intensity of pain increases as the numbers increase, and the number "10" means "I feel the most severe pain". An increase in the score obtained from the scale in the assessment indicates that the pain is increasing. Each patient will be administrated three times.
Before insulin administration on day, 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
Time Frame: Before insulin administrated on day one, Time Frame: After two insulin administration on the second day.
Questionnaire measures fear of self-injection and testing in diabetic individuals who require insulin. Questionnaire, which contains 15 statements, consists of two sub-dimensions: fear of self-injecting (6 statements) and fear of self-testing (9 statements). Each statement has a four-point Likert-type scoring ranging from 0 to 3 (0= almost never, 1= sometimes, 2= often, 3= almost always). The evaluation of the questionnaire form can be done by taking the average or raw score for the two sub-dimensions and the entire form. When taken as raw score, self-injection fear score varies between 0-18, self-testing fear score between 0-27, and total fear score between 0-45. Increasing score indicates increasing fear. Each patient will be administrated three times.
Before insulin administrated 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 (Estimated)

January 30, 2025

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 18, 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 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DICLE-ARDASURUCU-002

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.

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