- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05000268
Examination of The Effects of Telerehabilitation in Painful Healthcare Workers With and Without COVID-19 Infection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
COVID-19 is a disease caused by severe acute coronavirus 2 infection and declared as a pandemic by the World Health Organization on March 11, 2020. In the period from March 11, when the first case was announced in Turkey, to the present day, the total number of cases has exceeded 2.3 million. COVID-19 is mainly transmitted by air droplets, aerosols and direct contact, and asymptomatic carriers are the main reason for rapid spread. While many professional groups are working at home during the pandemic process; the risk of contracting COVID-19 has increased, especially in healthcare workers working in high-risk departments of hospitals where COVID-19 patients are treated.
Along with symptoms such as fever, dry cough and shortness of breath, common musculoskeletal problems such as muscle pain, joint pain and fatigue, anxiety, depression and deterioration in sleep quality have been observed in COVID-19 patients. It can take weeks to get over the COVID-19 disease; however, some symptoms persist even after the infection has cleared. The continuation of physical, cognitive and psychological problems in COVID-19 patients recovering from the acute phase of the disease is called 'Post-COVID-19 Syndrome'. A good evaluation and treatment is required to prevent these symptoms in individuals with COVID-19.
Telerehabilitation refers to providing rehabilitation services using electronic communication technologies. In the current pandemic process, the use of telerehabilitation has increased all over the world to help patients without compromising the social distance rule. There is no need for protective equipment as there is no physical contact during telerehabilitation sessions. As a result, patient satisfaction and treatment efficiency are increased by enabling more effective and natural human interaction.
In the literature, there are studies examining the effects of telerehabilitation on individuals who have had COVID-19, but studies examining the effects on healthcare workers who have experienced COVID-19 are insufficient. In this study, which is planned to be done, it is aimed to examine the effects of myofascial relaxation technique on pain and other symptoms through telerehabilitation. The aim of the study is to examine the effects of myofascial relaxation technique applied with the telerehabilitation method on pain level, anxiety, depression, sleep, fatigue and kinesiophobia in healthcare workers with and without COVID-19 infection with pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bolu
-
Merkez, Bolu, Turkey
- Ceyhun TOPCUOĞLU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pain associated with COVID-19 infection and persistence of this condition after infection
- Presence of non-COVID-19 related pain and no history of COVID-19 infection
- Being a health worker and working actively
- Volunteering
Exclusion Criteria:
- Using psychiatric medication
- Continuing history of active COVID-19 infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Painful Healthcare Workers with COVID-19
Healthcare workers who have had COVID-19 infection in the past and are now in pain without COVID-19 infection
|
Participants will be given telerehabilitation methods, progressive myofascial relaxation techniques and simple posture correction exercises every other day for 2 weeks. The exercises will be performed as follows:
|
|
ACTIVE_COMPARATOR: Painful Health Care Workers without COVID-19
Healthcare workers with past and present pain without COVID-19 infection
|
Participants will be given telerehabilitation methods, progressive myofascial relaxation techniques and simple posture correction exercises every other day for 2 weeks. The exercises will be performed as follows:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: 2 minutes
|
The intensity of pain felt by individuals in their muscles and joints will be evaluated with a visual analog scale.
The Visual Analog Scale is scored from 0 to 10.
On this scale, "0" indicates no pain, "10" indicates unbearable severity.
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Time Frame: 5 minutes
|
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index.
This questionnaire is a 19-item scale that assesses sleep quality and disturbance over the past month.
A total score of less than 5 indicates good sleep quality.
A total score greater than 5 indicates that sleep quality is impaired.
|
5 minutes
|
|
Fatigue Severity Scale
Time Frame: 2 minutes
|
Fatigue will be evaluated with the Fatigue Severity Scale.
The score of the scale, which consists of a total of 9 questions, varies between 9 and 63, while a total score of 36 and above indicates fatigue.
|
2 minutes
|
|
Tampa Scale of Kinesiophobia
Time Frame: 2 minutes
|
Tampa Kinesiophobia Scale will be used to assess fear of movement.
Individuals get a total score between 17-68.
High scores on the scale indicate high kinesiophobia.
|
2 minutes
|
|
The Patient Health Questionnaire-4
Time Frame: 2 minutes
|
Anxiety and depression will be assessed by the Patient Health Questionnaire-4.
This questionnaire In the last 2 weeks, the total score in this questionnaire, which consists of 4 questions in total, is between 0-12, and as the scores increase, the psychological distress situation increases.
|
2 minutes
|
|
Modified Borg Dyspnoea Scale
Time Frame: 2 minutes
|
The perception of shortness of breath will be measured with the Modified Borg Dyspnoea Scale.
Higher scores on this scale indicate increased dyspnea.
|
2 minutes
|
|
Modified Medical Research Council Dyspnea Scale
Time Frame: 2 minutes
|
The perception of shortness of breath during activities of daily living was evaluated using the Modified Medical Research Council Dyspnea Scale.
Individuals are asked to choose the statement that best describes the severity of dyspnea among 5 statements scored between 0 and 4. High scores indicate an increased level of dyspnea.
|
2 minutes
|
|
Hospital Anxiety and Depression Scale
Time Frame: 2 minutes
|
Anxiety and depression levels will be evaluated with the Hospital Anxiety and Depression Scale.
There are 14 questions in total in the scale and each question is scored between 0 and 3.
While the questions with odd number of questions evaluate anxiety symptoms; Questions with an even number of questions evaluate the symptoms of depression.
High scores indicate increased anxiety and depression.
While the cut-off point for anxiety is 10; The cut-off point for depression is 7.
|
2 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-CT-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19 Respiratory Infection
-
PfizerActive, not recruitingCOVID-19 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | COVID-19 Vaccines | SARS-CoV-2 Infection, COVID19 | COVID-19 Vaccination | SARS-CoV-2 Infection, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionUnited States
-
PfizerRecruitingRespiratory Tract Diseases | COVID-19 | Pneumonia | Lung Diseases | Coronavirus Disease 2019 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | Upper Respiratory Tract Infections | Respiratory Tract Infection | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionBelgium
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCOVID-19 | Coronavirus Disease 2019 | COVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Acute Respiratory Distress Syndrome | COVID-19 Acute Bronchitis | COVID-19 Lower Respiratory InfectionUnited States
-
Aga Khan UniversityCompletedCOVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Lower Respiratory InfectionPakistan
-
Duke UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Active, not recruitingCOVID-19 Vaccine | COVID-19 Respiratory Infection | SARS CoV 2 InfectionUnited States
-
KARE BiosciencesBiomedical Advanced Research and Development Authority; BioLink Life Sciences... and other collaboratorsRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory InfectionIndia
-
Tiziana Life Sciences LTDWithdrawnCovid19 | COVID-19 Respiratory Infection | COVID-19 Lower Respiratory Infection
-
Catalysis SLCompletedRespiratory Tract Infections | Covid19 | SARS-CoV2 Infection | COVID-19 Pneumonia | COVID-19 Respiratory Infection | Viral Infection | Infection, CoronavirusKazakhstan
-
Patrick RobinsonRecruitingCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Acute BronchitisUnited States
-
Medical University of LodzRecruitingCOVID-19 | COVID-19 Pneumonia | COVID-19 Respiratory InfectionPoland
Clinical Trials on Progressive Myofascial Relaxation Exercise
-
Eastern Mediterranean UniversityCompletedPremenstrual Syndrome | Chronic Pelvic Pain | Premenstrual PainCyprus
-
Gazi UniversityCompletedProgressive Muscle Relaxation ExerciseTurkey
-
Ege UniversityCompletedRestless Legs Syndrome
-
Kahramanmaraş İstiklal UniversityRecruitingDiabetic PatientsTurkey
-
Mustafa Kemal UniversityCompletedProgressive Muscle Relaxation ExerciseTurkey
-
Mustafa Kemal UniversityCompletedFatigue | Intensive Care NurseTurkey
-
kıvan çevik kayaRecruiting
-
TC Erciyes UniversityNot yet recruitingBurnout | Comfort | Life Satisfaction | Progressive Relaxation Exercise
-
Ataturk UniversityRecruiting
-
Aksaray UniversityRecruiting