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

NCT ID: NCT06790550

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2025-07-30

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Insulin; Fear; Pain; Injection; Music Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Music group

Music will be played during the insulin injection process

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: OTHER

Music will be played during the insulin injection process

Control group (Music free)

patients without of experimental Music

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music Therapy

Music will be played during the insulin injection process

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dicle University

OTHER

Sponsor Role: lead

Responsible Party

Hamdiye ARDA SÜRÜCÜ

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dicle Univertsity

Diyarbakır, South East, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DICLE-ARDASURUCU-002

Identifier Type: -

Identifier Source: org_study_id