- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04568005
Evaluation of Lymphedema Patients Status During Covid-19 Pandemic
5 de octubre de 2020 actualizado por: 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 .
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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).
Tipo de estudio
De observación
Inscripción (Actual)
60
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ataşehir
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Istanbul, Ataşehir, Pavo, 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Primary or secondary lymphedema patients who aged over 18.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Otro
- Perspectivas temporales: Transversal
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Coronavirus Phobia Scale
Periodo de tiempo: 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 .
|
1 day
|
Lymphedema Quality of Life Arm
Periodo de tiempo: 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
|
1 day
|
Lymphedema Quality of Life Leg
Periodo de tiempo: 1 day
|
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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Feyza Akan Begoğlu, MD, Fatih Sultan Mehmet Training and Research Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2020
Finalización primaria (Actual)
1 de agosto de 2020
Finalización del estudio (Actual)
1 de agosto de 2020
Fechas de registro del estudio
Enviado por primera vez
25 de septiembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
25 de septiembre de 2020
Publicado por primera vez (Actual)
29 de septiembre de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de octubre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
5 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Enfermedades linfáticas
- Neumonía Viral
- Neumonía
- Enfermedades pulmonares
- COVID-19
- Linfedema
Otros números de identificación del estudio
- feyzaakanbegoglu
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .