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Completed

NCT Number: NCT06790550

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fear of Injections Glucose Metabolism Disorders Iatrophobia Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Midyat State Hospital

Midyat, Mardin, 47500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-Selected Music Listening

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dicle University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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