Effects of Self-Selected Music on Self-Injection Fear, Blood Glucose Testing Fear, and Pain

August 25, 2026 updated by: Hamdiye ARDA SÜRÜCÜ, Dicle University

The Effects of Self-Selected Music on Fear of Self-Injection, Fear of Blood Glucose Testing, and Pain in Adults With Type 2 Diabetes

Fear and pain associated with self-insulin injection and blood glucose self-testing may negatively affect diabetes self-management. This randomized, parallel-group trial evaluated the effects of self-selected music on fear of self-injection, fear of blood glucose self-testing, and procedural pain in adults with type 2 diabetes. Sixty hospitalized participants were allocated to a self-selected music intervention group (n=30) or a standard care control group (n=30). On Day 1, both groups underwent routine blood glucose monitoring and self-insulin injection during morning and evening sessions. On Day 2, participants in the intervention group listened to self-selected music through headphones immediately before and throughout both procedures, whereas the control group continued to receive standard care without music. Fear was assessed using the Diabetes Fear of Injecting and Self-Testing Questionnaire, and pain was assessed using the Visual Analogue Scale at four time points over two days.

Study Overview

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Mardin
      • Midyat, Mardin, Turkey (Türkiye), 47500
        • Midyat State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2024

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 18, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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