- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04568005
Evaluation of Lymphedema Patients Status During Covid-19 Pandemic
5. Oktober 2020 aktualisiert von: 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 .
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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).
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
60
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Ataşehir
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Istanbul, Ataşehir, Truthahn, 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Primary or secondary lymphedema patients who aged over 18.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Sonstiges
- Zeitperspektiven: Querschnitt
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Coronavirus Phobia Scale
Zeitfenster: 1 day
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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
Zeitfenster: 1 day
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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
Zeitfenster: 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
Zeitfenster: 1 day
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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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Feyza Akan Begoğlu, MD, Fatih Sultan Mehmet Training and Research Hospital
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juni 2020
Primärer Abschluss (Tatsächlich)
1. August 2020
Studienabschluss (Tatsächlich)
1. August 2020
Studienanmeldedaten
Zuerst eingereicht
25. September 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
25. September 2020
Zuerst gepostet (Tatsächlich)
29. September 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Oktober 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. Oktober 2020
Zuletzt verifiziert
1. Oktober 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- feyzaakanbegoglu
Plan für individuelle Teilnehmerdaten (IPD)
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Nein
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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