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Examination of The Effects of Telerehabilitation in Painful Healthcare Workers With and Without COVID-19 Infection

Primary Purpose

COVID-19 Respiratory Infection

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive Myofascial Relaxation Exercise
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Respiratory Infection focused on measuring COVID-19, telerehabilitation, pain, healthcare workers, progressive myofascial relaxation technique

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ceyhun TOPCUOĞLU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Painful Healthcare Workers with COVID-19

Painful Health Care Workers without COVID-19

Arm Description

Healthcare workers who have had COVID-19 infection in the past and are now in pain without COVID-19 infection

Healthcare workers with past and present pain without COVID-19 infection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 6, 2021
Last Updated
October 27, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05000268
Brief Title
Examination of The Effects of Telerehabilitation in Painful Healthcare Workers With and Without COVID-19 Infection
Official Title
Examination of The Effects of Telerehabilitation in Painful Healthcare Workers With and Without COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Respiratory Infection
Keywords
COVID-19, telerehabilitation, pain, healthcare workers, progressive myofascial relaxation technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Painful Healthcare Workers with COVID-19
Arm Type
Active Comparator
Arm Description
Healthcare workers who have had COVID-19 infection in the past and are now in pain without COVID-19 infection
Arm Title
Painful Health Care Workers without COVID-19
Arm Type
Active Comparator
Arm Description
Healthcare workers with past and present pain without COVID-19 infection
Intervention Type
Other
Intervention Name(s)
Progressive Myofascial Relaxation Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
5 minutes
Title
Fatigue Severity Scale
Description
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.
Time Frame
2 minutes
Title
Tampa Scale of Kinesiophobia
Description
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.
Time Frame
2 minutes
Title
The Patient Health Questionnaire-4
Description
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.
Time Frame
2 minutes
Title
Modified Borg Dyspnoea Scale
Description
The perception of shortness of breath will be measured with the Modified Borg Dyspnoea Scale. Higher scores on this scale indicate increased dyspnea.
Time Frame
2 minutes
Title
Modified Medical Research Council Dyspnea Scale
Description
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.
Time Frame
2 minutes
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ceyhun TOPCUOĞLU
City
Merkez
State/Province
Bolu
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Examination of The Effects of Telerehabilitation in Painful Healthcare Workers With and Without COVID-19 Infection

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