Type 2 Diabetes Mellitus (T2DM)NCT06790550
Effects of Self-Selected Music on Self-Injection Fear, Blood Glucose Testing Fear, and Pain
A study testing Self-Selected Music Listening in people with Type 2 Diabetes Mellitus (T2DM) and Pain, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Pain, Fear of Injections
- What is being tested?
- Self-Selected Music Listening
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes for at least one year
- Performing self-insulin injection at least twice daily
- Performing self-monitoring of blood glucose
Who cannot join
- Having gestational diabetes mellitus or Type 1 diabetes
- Having a hearing impairment that could prevent listening to music through headphones
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Pain, Fear of Injections
- Being tested
- Self-Selected Music Listening
- Keywords
- type 2 diabetes mellitus, self-insulin injection, blood glucose testing, fear, pain, self-selected music, music intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Pain, Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Selected Music ListeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Selected Music Listening | Experimental | 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. Receives: Behavioral: Self-Selected Music Listening |
| Standard Care Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
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.
Measured: 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 outcomes (1)
Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start31 Mar 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to a self-selected music intervention group or a standard care control group in a parallel-group design. Outcomes were assessed during morning and evening sessions on two consecutive study days.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdiye ARDA SÜRÜCÜ, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790550
- Sponsor's protocol ID
- DICLE-ARDASURUCU-002
- Status last verified
- Aug 2026
- First submitted
- 18 Jan 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06790550
- Acronym / sponsor ID
- DICLE-ARDASURUCU-002
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Pain, Fear of Injections
- Keywords
- type 2 diabetes mellitus, self-insulin injection, blood glucose testing, fear, pain, self-selected music, music intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to a self-selected music intervention group or a standard care control group in a parallel-group design. Outcomes were assessed during morning and evening sessions on two consecutive study days.
| Arm | Type | Receives |
|---|---|---|
| Self-Selected Music Listening | Experimental | Behavioral: Self-Selected Music ListeningParticipants 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. |
| Standard Care Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes for at least one year
- Performing self-insulin injection at least twice daily
- Performing self-monitoring of blood glucose
Key exclusion criteria (2 listed)
- Having gestational diabetes mellitus or Type 1 diabetes
- Having a hearing impairment that could prevent listening to music through headphones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Selected Music ListeningParticipants 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. | Behavioural | Self-Selected Music Listening |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Selected Music Listening in people with Type 2 Diabetes Mellitus (T2DM) and Pain, run by Dicle University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.