- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06555770
Effekter av musikk og påføring av stressball på pasienter under kataraktkirurgi
Effekter av bruk av musikk og stressball på pasienter under kataraktkirurgi Undersøker effekten på angst og smerte
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Samsun, Tyrkia (Türkiye)
- Samsun Gazi State Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inkluderingskriterier:
- Å være 18 år eller eldre og gjennomgå PHACO-kirurgi,
- Har ikke hørsels- eller persepsjonsproblemer,
- Å ikke ha noen fysiske problemer med å klemme en stressball,
- Etter å ha gjennomgått kataraktoperasjon for første gang,
- Å være villig til å delta i forskningen.
Ekskluderingskriterier:
- Enhver bruk av smertestillende eller anxiolytika innen 24 timer før operasjonen,
- Overgang fra aktuell til generell anestesi under operasjon,
- En psykiatrisk diagnose.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Stress ball
Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward.
State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward.
Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II).
Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise.
The stress ball will be used for 15 minutes during cataract surgery.
Patients will be reminded during the procedure to continue the intervention as instructed.
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Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise.
The stress ball will be used for 15 minutes during cataract surgery.
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Eksperimentell: Music intervention
Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward.
State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward.
Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II).
According to the randomization, patients assigned to the music intervention group will be asked to select their preferred music from a prepared playlist.
The playlist will include 50 tracks representing pop music, Turkish classical music, regional folk music, instrumental music, and religious music.
The selected music will be played for 15 minutes during cataract surgery.
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Patients assigned to the music intervention group will select their preferred music from a prepared playlist.
The selected music will be played for 15 minutes during cataract surgery.
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Ingen inngripen: Control
Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale.
The patient in the control group will not be given any intervention.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Smerte (visuell analog skala)
Tidsramme: 10 minutter etter operasjonen
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Gradering gjøres med en 10 cm lang horisontal eller vertikal linjal på skalaen og "0" betyr ingen smerte og "10" betyr den mest alvorlige smerten. Pasienten markerer intensiteten av smerte han føler på linjalen. Hvis den markerte verdien er mellom 1-4, indikerer det mild smerte, mellom 5-6 indikerer moderat smerte, og mellom 7-10 indikerer sterke smerter. I søknaden ble pasienten bedt om å markere smerteintensiteten han følte på linjalen og verdien ble målt og registrert. |
10 minutter etter operasjonen
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Pain (Visual Analog Scale)
Tidsramme: Immediately after surgery
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Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded. |
Immediately after surgery
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Anxiety (Visual Analog Scale-Anxiety)
Tidsramme: approximately 5-10 minutes before surgery
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Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded. |
approximately 5-10 minutes before surgery
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Anxiety (Visual Analog Scale-Anxiety)
Tidsramme: Immediately after surgery
|
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded. |
Immediately after surgery
|
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Anxiety (Visual Analog Scale-Anxiety)
Tidsramme: 10 minutes after surgery
|
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded. |
10 minutes after surgery
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State-Trait Anxiety Inventory (STAI-II)
Tidsramme: Approximately 5-10 minutes before surgery
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Trait anxiety will be assessed using the State-Trait Anxiety Inventory-II (STAI-II), which consists of 20 items and measures an individual's general tendency to experience anxiety.
Higher scores indicate higher levels of trait anxiety.
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Approximately 5-10 minutes before surgery
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2490Akdeniz
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