Clinical trial NCT04568005: Evaluation of Lymphedema Patients Status During Covid-19 Pandemic
Official title: Evaluation of Lymphedema Patients Treatment Processes, Health Status, Coronavirus Phobia, Quality of Life, Anxiety and Depression During Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Keywords: lymphedema, coronavirus, LYMQOL, HADS
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary or secondary lymphedema patients who aged over 18.

Brief summary: 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 .

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Coronavirus Phobia Scale
timeFrame: 1 day
measure: Lymphedema Quality of Life Arm
timeFrame: 1 day
measure: Lymphedema Quality of Life Leg
timeFrame: 1 day
measure: Hospital Anxiety and Depression Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Training and Research Hospital
state: Ataşehir
Study officials:
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Feyza Akan Begoğlu, MD
role: PRINCIPAL_INVESTIGATOR
References: