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Not yet recruiting NCT06790550

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

No phase Interventional Type 2 Diabetes Mellitus (T2DM) Insulin Fear Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music Therapy.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus (T2DM), Insulin, Fear, Pain. Basic parameters: 15 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Other Music Therapy
    Music will be played during the insulin injection process

Primary outcome measures

  • Visual Analogue Scale [Time frame: Before insulin administration on day, Time Frame: After two insulin administration on the second day]
Secondary outcome measures (1)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Dicle Univertsity — Diyarbakır

Identifiers

NCT: NCT06790550 · DICLE-ARDASURUCU-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗