Clinical trial NCT06790550: Music Effect on the Self-Injection, Testing Fear and Pain
Official title: Examination of Music's Demonstration to Self-Injection, Fear of Testing and Pain in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Insulin
Fear
Pain
Injection
Music Therapy
Keywords: type 2 diabetes mellitus
Insulin
fear
pain
insulin injection
music
Lead sponsor: Dicle University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study group and control group
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Before insulin administration on day, Time Frame: After two insulin administration on the second day
Secondary outcomes:
measure: Diabetes Fear of Self Injecting and Self-testing Questionnaire
timeFrame: Before insulin administrated on day one, Time Frame: After two insulin administration on the second day.
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Dicle Univertsity
state: South East
Study officials:
References: