- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04568005
Evaluation of Lymphedema Patients Status During Covid-19 Pandemic
5. oktober 2020 oppdatert av: Fatih Sultan Mehmet Training and Research Hospital
Evaluation of Lymphedema Patients Treatment Processes, Health Status, Coronavirus Phobia, Quality of Life, Anxiety and Depression During Covid-19 Pandemic
The pandemic, which started in China at the end of 2019, appeared in our country in a short time.
Most hospitals and physicians were only concerned with the treatment of these patients.
One of the most victimized patient groups in this duration was lymphedema patients who were in need of continuous follow-up and rehabilitation at necessary periods, but were also at risk in terms of covid-19 infection and could not go to hospitals unless necessary.
The treatment of both primary and secondary lymphedema patients has been interrupted or delayed.
This process has affected the health status, treatment processes and quality of life of the lymphedema patient group.
The current situation may have caused them anxiety and depression as a result of infection fear.
In this study, we aimed to evaluate the treatment processes, health status, coronavirus phobia, anxiety, and depression states of the lymphedema patients .
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
60 primary and secondary lymphedema male and female patients with stage I,II,III lymphedema older than 18 years old over who were followed up in the lymphedema outpatient clinic of the Physical Medicine and Rehabilitation Clinic were included in the study.They were called by phone.
Permission was asked for questioning from the patients reached.
A hundred lymphedema patients were called and 60 patients were reached or agreed to be interviewed.
The questions on the form and scales were read clearly to the patients who accepted the interview and were asked to be answered by the patient.
The health status of the admitted patients during the covid-19 pandemic period and the treatment processes were questioned with the form we prepared.These forms were included socio-demographic features, physical, and detailed medical histories.Edema staging was evaluated by the International Society of Lymphology (ISL) lymphedema staging classification.This information was filled in from patients' files.
The pandemic process was evaluated in the other part of the form.
Working status, mobilization during the pandemic process, whether he/she or his/her relative was diagnosed with coronavirus infection, whether he/she received suplemental treatment, how much he/she paid attention to hand-foot hygine, whether his/her swelling increased, whether he/she had a cellulite attack, whether he/she regular self-manual lymphatic drainage and/or exercise, It was questioned whether there was an increase in a different symptom other than swelling, eating habits and weight gain, most recently whether he used pressure stocking regularly.In addition, the fear because of the covid-19 virus was questioned with the coronavirus-19 phobia scale (CP19-S), quality of life with lymphedema quality of life arm / leg (LYMQOL), and anxiety and depression with the hospital anxiety and depression scale (HADS).
Studietype
Observasjonsmessig
Registrering (Faktiske)
60
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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Ataşehir
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Istanbul, Ataşehir, Tyrkia, 34752
- Fatih Sultan Mehmet Training and Research Hospital
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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
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Primary or secondary lymphedema patients who aged over 18.
Beskrivelse
Inclusion Criteria:
- Primary or secondary lymphedema patients with stage I,II,II stage
- Aged over 18 years old
- Upper or lower extremity lymphedema
Exclusion Criteria:
- Patients under the age of 18
- Patients who do not accept phone calls.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Annen
- Tidsperspektiver: Tverrsnitt
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Coronavirus Phobia Scale
Tidsramme: 1 day
|
The CP19-S has 20 items which is a self-report instrument with a five-point Likert-type scale to assess the levels of coronavirus (covid-19) phobia.
All items are rated on a 5 point scale from "strongly disagree (1)" to "strongly agree (5)."
The scores on the scale can range between 20 and 100 and a higher score indicates a greater phobia in the respected subscales (psychological, psycho-somatic, economic and social) and total scale.
In the present study total scale scores ranged from 20 to 100 .
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1 day
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Lymphedema Quality of Life Arm
Tidsramme: 1 day
|
The LYMQOL-Arm consists of four domains with 28 items.
These domains are symptoms, appearance, function, and mood.
The answers were evaluated on a four-point Likert scale (1= not at all 2= a little, 3= quite a bit, 4= a lot).
Each item received a score between 1 and 4, with higher scores indicating a worse QOL.
Domain totals were calculated by adding the individual scores and dividing the total by the number of questions answered (If >50% of questions per domain were not answered this cannot be calculated *and =0).
If the item was not scored and left blank or not applicable, this was scored with a 0. The four domains and their corresponding questions are: Function 1 (a-h), 2,3, Appearance 4,5,6,7,8 Symptoms 9,10,11,12,13,14 and Emotion 15,16,17,18,19,20.
Overall QOL (Q21) is scored as the value marked by the patient, between 0-10
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1 day
|
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Lymphedema Quality of Life Leg
Tidsramme: 1 day
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The LYMQOL-Leg consists of 27 items: 26 multiple-choice questions and 1 rating question.
It covers four domains: symptoms, appearance, function, and mood.
Scoring and calculating is same with the arm scale but differences are; function 1 (a-f), 2,3 appearance 4,5,6,7,8,9,10 symptoms 11,12,13,14,15 and emotion 16,17,18,19,20,21.
Overall quality of life (Q22) is scored as the value marked by the patient, between 0-10.
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1 day
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Hospital Anxiety and Depression Scale
Tidsramme: 1 day
|
It consists of 14 items with two subscales (seven items for anxiety and seven items for depression).
Each item is scored 0-3.
Each subscale is scored between 0 and 21.
The aim of the scale is not to make a diagnosis, but to determine the risk group bt screening anxiety and depression in a short time in patients with physical diseases.
The cut-off points of the Turkish version of the HADS were determined as 10 for the anxiety subscale and 7 for the depression subscale.
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1 day
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Feyza Akan Begoğlu, MD, Fatih Sultan Mehmet Training and Research 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)
1. juni 2020
Primær fullføring (Faktiske)
1. august 2020
Studiet fullført (Faktiske)
1. august 2020
Datoer for studieregistrering
Først innsendt
25. september 2020
Først innsendt som oppfylte QC-kriteriene
25. september 2020
Først lagt ut (Faktiske)
29. september 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- feyzaakanbegoglu
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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