- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06790550
Effects of Self-Selected Music on Self-Injection Fear, Blood Glucose Testing Fear, and Pain
The Effects of Self-Selected Music on Fear of Self-Injection, Fear of Blood Glucose Testing, and Pain in Adults With Type 2 Diabetes
Study Overview
Status
Intervention / Treatment
Detailed Description
This completed randomized controlled trial was conducted in the internal medicine ward of Midyat State Hospital between March 31, 2024 and April 30, 2025. A total of 72 adults with type 2 diabetes were assessed for eligibility; 5 did not meet the eligibility criteria and 7 declined to participate. Sixty participants were enrolled and allocated to the self-selected music intervention group (n=30) or the standard care control group (n=30).
On Day 1, participants in both groups underwent routine blood glucose monitoring and self-insulin injection procedures during morning and evening sessions. On Day 2, participants in the intervention group listened to self-selected music through headphones immediately before and throughout the morning and evening blood glucose monitoring and self-insulin injection sessions. Participants in the control group underwent the same procedures and assessment schedule without music. The D-FISQ and VAS were administered at four measurement points over the two-day study period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mardin
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Midyat, Mardin, Turkey (Türkiye), 47500
- Midyat State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Type 2 diabetes for at least one year
- Performing self-insulin injection at least twice daily
- Performing self-monitoring of blood glucose
Exclusion Criteria:
- Having gestational diabetes mellitus or Type 1 diabetes
- Having a hearing impairment that could prevent listening to music through headphones
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Selected Music Listening
Participants listened to self-selected music through headphones during the morning and evening blood glucose testing and self-insulin injection sessions on Day 2. Music listening commenced immediately before the procedures and continued throughout both procedures.
Outcomes were assessed at four time points over two days.
|
Participants listened to music of their own choice through headphones during the morning and evening sessions on Day 2. Music listening commenced immediately before blood glucose testing and self-insulin injection and continued throughout both procedures.
Participants were free to select music in their preferred language and genre.
|
|
No Intervention: Standard Care Control Group
Participants received standard care and performed routine blood glucose testing and self-insulin injection without music.
They underwent the same morning and evening procedures and the same four-assessment schedule as the intervention group over two days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: Immediately after the blood glucose testing and self-insulin injection sessions conducted in the morning and evening on Day 1 and Day 2; four assessments over two days.
|
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.
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Immediately after the blood glucose testing and self-insulin injection sessions conducted in the morning and evening on Day 1 and Day 2; four assessments over two days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ)
Time Frame: Immediately after the blood glucose testing and self-insulin injection sessions conducted in the morning and evening on Day 1 and Day 2; four assessments over two days.
|
The D-FISQ assesses fear of self-injection and fear of blood glucose self-testing in individuals with diabetes who require insulin.
The questionnaire consists of 15 items and two subscales: Fear of Self-Injection (6 items) and Fear of Self-Testing (9 items).
Each item is scored from 0 to 3 (0=almost never, 1=sometimes, 2=often, and 3=almost always).
The Fear of Self-Injection subscale score ranges from 0 to 18, the Fear of Self-Testing subscale score ranges from 0 to 27, and the total score ranges from 0 to 45. Higher scores indicate greater fear.
The total score and the two subscale scores were analyzed separately.
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Immediately after the blood glucose testing and self-insulin injection sessions conducted in the morning and evening on Day 1 and Day 2; four assessments over two days.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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