- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06790550
Musikeffekt på selvinjektion, test af frygt og smerte
Undersøgelse af musikens demonstration til selvinjektion, frygt for test og smerte hos patienter med type 2-diabetes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Forskningstype:
Forskningen vil blive udført som en randomiseret kontrolleret eksperimentel model.
Forskningsunivers og prøve:
Forskningsprøven vil bestå af patienter, der er diagnosticeret med type 2 -diabetes, der er indlagt på Midyat State Hospital. Prøven af forskningen forventes at bestå af 100 frivillige type 2 -diabetespatienter, der anvendte på Midyat State Hospital.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Mardin
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Midyat, Mardin, Tyrkiet (Türkiye), 47500
- Midyat State Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Type 2-diabetes i mindst et år
- Selvadministrerende insulininjektion
- Selvadministrerende glukometer, insulinpen eller insulinpumpe
Ekskluderingskriterier:
- dårligt mentalt helbred
- At have svangerskabsdiabetes mellitus eller type 1 -diabetes
- Ingen høreproblemer
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Visual Analogue Scale (VAS)
Tidsramme: 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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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ)
Tidsramme: 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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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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DICLE-ARDASURUCU-002
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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