COVID-19 Respiratory InfectionNCT05000268
Examination of The Effects of Telerehabilitation in Painful Healthcare Workers With and Without COVID-19 Infection
A study testing Progressive Myofascial Relaxation Exercise in people with COVID-19 Respiratory Infection, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- Progressive Myofascial Relaxation Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2022to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Using psychiatric medication
- Continuing history of active COVID-19 infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- Progressive Myofascial Relaxation Exercise
- Keywords
- COVID-19, telerehabilitation, pain, healthcare workers, progressive myofascial relaxation technique
- Medical subject headings
- COVID-19, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Myofascial Relaxation ExerciseOther
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:
- First, focus on creating tension in the body by contracting all your body muscles and feeling the body tension by holding this tight position for 3-5 seconds. Then relax and relax and focus on feeling the relaxed position of the muscles for 10-15 seconds. Then, the same contraction and relaxation movements will be applied in the feet, legs, hips, waist, chest, shoulders, arms and face areas, respectively. They will be asked to do these exercises in the morning and evening while lying in bed.
| Study group | Role | What they receive |
|---|---|---|
| Painful Healthcare Workers with COVID-19 | Active comparator | Healthcare workers who have had COVID-19 infection in the past and are now in pain without COVID-19 infection Receives: Other: Progressive Myofascial Relaxation Exercise |
| Painful Health Care Workers without COVID-19 | Active comparator | Healthcare workers with past and present pain without COVID-19 infection Receives: Other: Progressive Myofascial Relaxation Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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.
Measured: 2 minutes
Secondary outcomes (7)
Pittsburgh Sleep Quality Index
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.
Measured: 5 minutes
Fatigue Severity Scale
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.
Measured: 2 minutes
Tampa Scale of Kinesiophobia
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.
Measured: 2 minutes
The Patient Health Questionnaire-4
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.
Measured: 2 minutes
Modified Borg Dyspnoea Scale
The perception of shortness of breath will be measured with the Modified Borg Dyspnoea Scale. Higher scores on this scale indicate increased dyspnea.
Measured: 2 minutes
Modified Medical Research Council Dyspnea Scale
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.
Measured: 2 minutes
Hospital Anxiety and Depression Scale
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start16 Jan 2022
- Primary completion30 May 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Participants will be divided into two groups as those with pain after COVID-19 infection and those with pain not related to COVID-19 infection. Both groups will be applied telerehabilitation methods, progressive myofascial relaxation techniques and simple posture correction exercises every other day for 2 weeks. Progressive myofascial relaxation exercises will be asked to do morning and evening while lying in bed. Posture exercises will be required to perform while standing, at least 2 or 3 sets during work.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Topcuoğlu, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000268
- Sponsor's protocol ID
- AIBU-FTR-CT-04
- Status last verified
- Oct 2022
- First submitted
- 6 Aug 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of The Effects of Telerehabilitation in Painful Healthcare Workers With and Without COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05000268
- Acronym / sponsor ID
- AIBU-FTR-CT-04
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- COVID-19, telerehabilitation, pain, healthcare workers, progressive myofascial relaxation technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be divided into two groups as those with pain after COVID-19 infection and those with pain not related to COVID-19 infection. Both groups will be applied telerehabilitation methods, progressive myofascial relaxation techniques and simple posture correction exercises every other day for 2 weeks. Progressive myofascial relaxation exercises will be asked to do morning and evening while lying in bed. Posture exercises will be required to perform while standing, at least 2 or 3 sets during work.
| Arm | Type | Receives |
|---|---|---|
| Painful Healthcare Workers with COVID-19 | Active comparator | Other: Progressive Myofascial Relaxation ExerciseHealthcare workers who have had COVID-19 infection in the past and are now in pain without COVID-19 infection |
| Painful Health Care Workers without COVID-19 | Active comparator | Other: Progressive Myofascial Relaxation ExerciseHealthcare workers with past and present pain without COVID-19 infection |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Using psychiatric medication
- Continuing history of active COVID-19 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Myofascial Relaxation ExerciseParticipants 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: * First, focus on creating tension in the body by contracting all your body muscles and feeling the body tension by holding this tight position for 3-5 seconds. Then relax and relax and focus on feeling the relaxed position of the muscles for 10-15 seconds. Then, the same contraction and relaxation movements will be applied in the feet, legs, hips, waist, chest, shoulders, arms and face areas, respectively. They will be asked to do these exercises in the morning and evening while lying in bed. | Other | Painful Health Care Workers without COVID-19, Painful Healthcare Workers with COVID-19 |
Primary outcome
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.
7 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: 5 minutes
Fatigue Severity Scale
Time frame: 2 minutes
Tampa Scale of Kinesiophobia
Time frame: 2 minutes
The Patient Health Questionnaire-4
Time frame: 2 minutes
Modified Borg Dyspnoea Scale
Time frame: 2 minutes
Modified Medical Research Council Dyspnea Scale
Time frame: 2 minutes
Hospital Anxiety and Depression Scale
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Myofascial Relaxation Exercise in people with COVID-19 Respiratory Infection, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.