Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center
31. august 2021 oppdatert av: Ricardo dos Reis, Barretos Cancer Hospital
Emotional Impact of the Way Conducting Cancer Patients to the Surgical Center: a Randomized Clinical Trial Comparing Transport by Stretcher on Wheels and Ambulation.
Cancer is an extremely aggressive disease, anxiety and depression are consequences some patients may develop from diagnosis continuing during treatment. A measures control of the cancer is surgery for removal tumor. The surgical procedure is often a difficult experience for patients and their relatives, and patients in the preoperative period are often psychological symptoms of anxiety and depression. A previous study with the objective analyzing patient's emotional repercussion according the type of transport to the surgical center reached the following result: patients who go to the surgical center feel more relaxed in the preoperative period.
The primary objective is to analyze emotional repercussion of patient diagnosed with cancer classified in Eastern Cooperative Oncology Group (ECOG) Performance Status 0 and 1 according type transport to the surgical center.
Studieoversikt
Detaljert beskrivelse
A randomized clinical trial, prospective collection to be performed at the Barretos Cancer Hospital, will be include 176 patients, 88 patients being allocated to transport to operating room by stretcher on wheels (group 1) and 88 patients being allocated to transport to operating room by ambulation (group 2).
Patients with indication elective surgery that meet the inclusion criteria will be included, and randomized for one of the groups, and may be referred by stretcher on wheels to the surgical center (group 1) or referred to the surgical center by ambulation (group 2).
The Hospital Anxiety and Depression Scale (HAD) and the survey developed for the present study Sati-Cir, Evaluation Questionnaire of Satisfaction with Healthcare in Surgery, will be the instruments used in data collection.
Participants will respond both after the course to the surgical center.
Studietype
Observasjonsmessig
Registrering (Faktiske)
176
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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SP
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Barretos, SP, Brasil, 14784-400
- Hospital do Cancer de Barretos
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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
14 år til 66 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
The study population will be organized including 176 patients sheduled for elective cancer surgery at Barretos Cancer Hospital, 88 patients bei ng allocated for transporting to the operating room by stretcher on wheels, and 88 patients elective allocated for transporting to the operating room by ambulation.
Beskrivelse
Inclusion Criteria:
- diagnosed cancer
- Age ≥18 years, ≤ 70 years
- Both sexes
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
- Patients classified as Zero or Low Risk by the fall risk assessment scale
- Indication elective surgery
Exclusion Criteria:
- Patients who present moments before surgery has an adverse event that could jeopardize the ambulation to the surgical center.
- Patients who are physically disabled and require assistance walking.
- Patients has indication bed in the Intensive Care Unit (UTI)
- Patients has previously diagnosed psychiatric disorders (severe depression, anxiety disorder, panic, among others).
- Patients doens't have an accompanying person on the day of surgery.
- Patients taking anxiolytic and antidepressant medications.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Transport on foot
Patients go to operating room walking with their families and with their normal clothes
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Patients go to operating room walking with their families and with their normal clothes
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Transport by stretcher on wheels
Patients go to operating room by stretcher on wheels and with hospital clothes.
Normal routine of our hospital.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety and depression levels
Tidsramme: up to 4 weeks
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Measure the anxiety and depression levels using Hospital Anxiety and Depression Scale (HAD) and the survey developed for the present study Sati-Cir, Evaluation Questionnaire of Satisfaction with Healthcare in Surgery
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up to 4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Gabriela da S Oliveira, Nurse, Barretos Cancer Hospital
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)
7. januar 2019
Primær fullføring (Faktiske)
30. august 2021
Studiet fullført (Faktiske)
30. august 2021
Datoer for studieregistrering
Først innsendt
13. juni 2018
Først innsendt som oppfylte QC-kriteriene
22. juni 2018
Først lagt ut (Faktiske)
3. juli 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1527/2018
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
IPD-planbeskrivelse
We do not intend to share our individual participant data to other researches
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .