Chronic PainNCT04878900
Effects of COVID-19 in Chronic Pain
An observational study of Chronic Pain and Covid19, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of the COVID-19 pandemic on pain, stress, sleep and quality of life in patients with chronic musculoskeletal pain and the relationships between them. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Covid19
- What is being tested?
- Survey
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Mar 2021
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain
Who may be able to join
- Patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain
Who cannot join
- Having a history of trauma and surgical intervention in the last 3 months,
- Having a history of known inflammatory rheumatic disease,
- Having a history of chronic severe systemic or neurological disease,
- Having a moderate or severe impairment of cognitive status determined by the minimental test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE EFFECTS OF THE COVID-19 PANDEMIC ON PAIN, STRESS, SLEEP AND QUALITY OF LIFE IN PATIENTS WITH CHRONIC MUSCULOSKELETAL PAIN
The aim of this study is to evaluate the effects of the COVID-19 pandemic on pain, stress, sleep and quality of life in patients with chronic musculoskeletal pain and the relationships between them. In this cross-sectional study, 100 volunteer patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain were included. Age, gender, body-mass index (BMI) and systemic diseases of the participants were recorded as demographic data. Data were collected regarding the area of the body where pain is most dominant in the musculoskeletal system and how long the pain has been in these area, whether there is routine use of analgesics before and after the pandemic and the amount if any, whether the person or the person's relatives have a history of COVID-19, whether exercising regularly before and after the pandemic. Afterwards, the participants were asked to evaluate their general pain severity and global well-being assesment with the visual analog scale (VAS) in the pre-pandemic period and in the last month. For pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad. The distance between the point marked by the patient and the starting point was measured. The higher the measured value meant the greater the severity of the patient's pain and the worse the patient's global assessment [11]. Subsequently, the patients were asked to answer questions on the Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI) and Nottingham Health Profile (NHP) scales.
- Conditions
- Chronic Pain, Covid19
- Being tested
- Survey
- Medical subject headings
- Chronic Pain, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey
What is being measured
The primary outcome is the main question the study is designed to answer.
General pain severity and global well-being assesment with the visual analog scale (VAS).
For pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad.
Measured: 2 months
Perceived Stress Scale (PSS)
It is a scale to evaluate how stressful some situations in life are perceived by the individual. The long form of the scale consists of 14 items in total. The situations given in each item are evaluated with a 5-point Likert-type scale (0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often). The scale has two short forms consisting of 10 and 4 items. The total score ranges from 0-56 for PSS-14, 0-40 for PSS-10, and 0-16 for PSS-4. The higher the scores, the greater the person's perception of stress.
Measured: 2 months
Pittsburgh Sleep Quality Index (PSQI)
It is a scale to evaluate sleep quality and disorders. It consists of 24 questions in total. 19 questions are self-assessment questions, 5 questions are assessment questions made by their spouse or roommate. 18 question items are used in scoring. The scale consists of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. While some of the components consist of a single question item, some are formed by grouping several items. Each component is scored between 0 and 3 points, and the total score of the components gives the total score of the scale. The higher the total score the worse the sleep quality.
Measured: 2 months
Nottingham Health Profile (NHP)
It is a general health status scale that evaluates perceived problems in physical, emotional and social areas and how these problems affect daily activities. The questions in the first part of the scale are about the health status of the people, and the questions in the second part are about the effects of their health status on daily life. The first part consists of 38 items in which each item is answered as yes or no. This section has a total of 6 sub-dimensions: pain, emotional reactions, sleep, social isolation and physical mobility and energy. The higher the score, the worse the perception of quality of life regarding health status. The second part consists of 7 items that question whether there are problems in the daily life areas that are most likely to be affected by the health condition of the person, such as work life, housework, social life, interpersonal relationships, sexual life, hobbies and holidays, each item being answered as yes or no.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Jan 2021
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem Bolkan Günaydın, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878900
- Sponsor's protocol ID
- 2020-3-16
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 10 May 2021
- 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 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECTS OF THE COVID-19 PANDEMIC ON PAIN, STRESS, SLEEP AND QUALITY OF LIFE IN PATIENTS WITH CHRONIC MUSCULOSKELETAL PAIN
- ClinicalTrials.gov ID
- NCT04878900
- Acronym / sponsor ID
- 2020-3-16
- Conditions
- Chronic Pain, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 May 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.
The aim of this study is to evaluate the effects of the COVID-19 pandemic on pain, stress, sleep and quality of life in patients with chronic musculoskeletal pain and the relationships between them. In this cross-sectional study, 100 volunteer patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain were included. Age, gender, body-mass index (BMI) and systemic diseases of the participants were recorded as demographic data. Data were collected regarding the area of the body where pain is most dominant in the musculoskeletal system and how long the pain has been in these area, whether there is routine use of analgesics before and after the pandemic and the amount if any, whether the person or the person's relatives have a history of COVID-19, whether exercising regularly before and after the pandemic. Afterwards, the participants were asked to evaluate their general pain severity and global well-being assesment with the visual analog scale (VAS) in the pre-pandemic period and in the last month. For pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad. The distance between the point marked by the patient and the starting point was measured. The higher the measured value meant the greater the severity of the patient's pain and the worse the patient's global assessment [11]. Subsequently, the patients were asked to answer questions on the Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI) and Nottingham Health Profile (NHP) scales.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain
Key inclusion criteria (1 listed)
- Patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain
Key exclusion criteria (4 listed)
- Having a history of trauma and surgical intervention in the last 3 months,
- Having a history of known inflammatory rheumatic disease,
- Having a history of chronic severe systemic or neurological disease,
- Having a moderate or severe impairment of cognitive status determined by the minimental test.
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 |
|---|---|---|
| SurveySurvey | Other | – |
Primary outcome
General pain severity and global well-being assesment with the visual analog scale (VAS).
Time frame: 2 months
For pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad.
Perceived Stress Scale (PSS)
Time frame: 2 months
It is a scale to evaluate how stressful some situations in life are perceived by the individual. The long form of the scale consists of 14 items in total. The situations given in each item are evaluated with a 5-point Likert-type scale (0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often). The scale has two short forms consisting of 10 and 4 items. The total score ranges from 0-56 for PSS-14, 0-40 for PSS-10, and 0-16 for PSS-4. The higher the scores, the greater the person's perception of stress.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 months
It is a scale to evaluate sleep quality and disorders. It consists of 24 questions in total. 19 questions are self-assessment questions, 5 questions are assessment questions made by their spouse or roommate. 18 question items are used in scoring. The scale consists of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. While some of the components consist of a single question item, some are formed by grouping several items. Each component is scored between 0 and 3 points, and the total score of the components gives the total score of the scale. The higher the total score the worse the sleep quality.
Nottingham Health Profile (NHP)
Time frame: 2 months
It is a general health status scale that evaluates perceived problems in physical, emotional and social areas and how these problems affect daily activities. The questions in the first part of the scale are about the health status of the people, and the questions in the second part are about the effects of their health status on daily life. The first part consists of 38 items in which each item is answered as yes or no. This section has a total of 6 sub-dimensions: pain, emotional reactions, sleep, social isolation and physical mobility and energy. The higher the score, the worse the perception of quality of life regarding health status. The second part consists of 7 items that question whether there are problems in the daily life areas that are most likely to be affected by the health condition of the person, such as work life, housework, social life, interpersonal relationships, sexual life, hobbies and holidays, each item being answered as yes or no.
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 10 May 2021.
- 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?
An observational study of Chronic Pain and Covid19, run by Ufuk 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 1 inclusion and 4 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 10 May 2021. 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?
General pain severity and global well-being assesment with the visual analog scale (VAS). (time frame: 2 months). The study lists 4 primary outcomes in all. 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 10 May 2021.