- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05010213
Plaster Patient Education With Roy Adaptation Model
15. desember 2021 oppdatert av: Nida AYDIN, Near East University, Turkey
The Effect of Training Given With the Roy Adaptation Model on the Self-care Agency and Coping Strategies of Patients With Plaster Casts.
The aim of this study is to determine the effect of training given with the Roy adaptation model on the self-care agency and coping strategies of patients with plaster casts.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
According to Global Burden of Disease data, fractures, which 436 million people suffer from each year, are the second most common musculoskeletal system disorder.
Plaster casts have been used in treatment of fractures since 1850, and they play an important role in extremity injuries and the healing of operative repairs.
In fractures treated with plaster, the bone alignment is corrected and this alignment is maintained with limited mobility.
However, if plaster casts are incorrectly applied or not properly taken care of, this may prevent the healing of fractures and can threaten the safety of patients.
Failure to comply with plaster-casting and cast-care principles can cause patients a range of immediate and delayed complications, including severe pain, edema, compartment syndrome, tissue necrosis, malunion, delayed union, nonunion, contracture, neurological problems, paralysis and pressure sores.
Orthopedic patients, and especially those with plaster casts, are susceptible to the side effects arising from immobility.
They thus need quality care and information to prevent or manage these side effects.
Nurses play an important role in prevention or early recognition of complications arising from plaster-casting and in providing the patient with information.
Orthopedic nursing requires special skills, knowledge and clinical judgement to provide the plaster cast-patient with safe, quality-care and to prevent complications.
Patient education and information are very important for those patients whose treatment continues at home after casting, in order that they can maintain their care and prevent complications.In this study, the sample size was determined with an effect size of 0.43 using the power analysis Gpower 3.1.9.7 program.
Accordingly, it was calculated that 29 patients were included in the intervention and control groups with a 5% margin of error and 80% power.
İt was decided to include at least 66 people in each working group with 10% surplus, considering that they might be lost in data collection.
Studietype
Intervensjonell
Registrering (Faktiske)
66
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Nicosia, Kypros, 99138
- Near East University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- With lower extremity fracture
- Have at least 6 weeks of plaster cast experience
Exclusion Criteria:
- Have communication problem
- Have restriction of movement before fracture
- Patient who can not speak very well Turkish
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Control group
There will be no intervention to the control group.
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Eksperimentell: Experimental group
The experimental group will be given training based on the roy adaptation model.
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Educational intervention
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-care agency scale score level
Tidsramme: At the beginning of plaster treatment, an avarage of 1 hour
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Score level of self-care agency before the patient education
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At the beginning of plaster treatment, an avarage of 1 hour
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Coping orientation to problems experienced (COPE)
Tidsramme: At the beginning of plaster treatment, an avarage of 1 hour
|
Score level of coping orientation to problems experienced before the patient education
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At the beginning of plaster treatment, an avarage of 1 hour
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-care agency scale score level
Tidsramme: At the end of treatment, an avarage of 1 week
|
Score level of coping orientation to problems experienced after the patient education
|
At the end of treatment, an avarage of 1 week
|
|
Coping orientation to problems experienced (COPE)
Tidsramme: At the end of treatment, an avarage of 1 week
|
Score level of coping orientation to problems experienced after the patient education
|
At the end of treatment, an avarage of 1 week
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2021
Primær fullføring (Faktiske)
20. oktober 2021
Studiet fullført (Faktiske)
8. desember 2021
Datoer for studieregistrering
Først innsendt
29. juli 2021
Først innsendt som oppfylte QC-kriteriene
10. august 2021
Først lagt ut (Faktiske)
18. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. januar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. desember 2021
Sist bekreftet
1. desember 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- NAYDIN
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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