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

NCT06790550 | Not Yet Recruiting

• 1 other identifier: DICLE-ARDASURUCU-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

type 2 diabetes mellitus; Insulin; fear; pain; insulin injection; music

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  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 Outcomes (1)

• Diabetes Fear of Self Injecting and Self-testing Questionnaire

  Before insulin administrated on day one, Time Frame: After two insulin administration on the second day.

Study Arms (2)

Music group

EXPERIMENTAL

Music will be played during the insulin injection process

Other: Music Therapy

Control group (Music free)

NO INTERVENTION

patients without of experimental Music

Interventions

Music Therapy OTHER

Music will be played during the insulin injection process

Music group

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes for at least one year
• Self-administering insulin injection
• Self-administering glucometer, insulin pen or insulin pump

You may not qualify if:

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

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle Univertsity

Diyarbakır, South East, 21100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: They do not know the experimental or control procedures that take place
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: study group and control group

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 24, 2025
• Study Start: January 30, 2025
• Primary Completion: May 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)