Pain in A Joint, Multiple SitesNCT04742335
Assessment of Pain, Occupational Fatigue, Sleep and Quality of Life in Nurses
An observational study of Pain in A Joint, Multiple Sites, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the pain, occupational fatigue, sleep and quality of life in nurses and the relationships between them. 102 participants working as nurses were included in the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain in A Joint, Multiple Sites
- What is being tested?
- Survey
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2020to 20 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 102 volunteer nurses over 18 years old.
Who may be able to join
- Being over 18 years old
- Working as a nurse
Who cannot join
- Being under the age of 18
- Having a history of serious trauma and orthopedic surgery in the last 1 year
- Having a chronic severe internal and neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the pain, occupational fatigue, sleep and quality of life in nurses and the relationships between them. 102 participants working as nurses were included in the study. Data on age, gender, height, weight, working year in the profession, weekly working hours, hand dominance, diagnosed diseases and marital status of the participants were collected. Subsequently, the questions included in the Nordic musculoskeletal questionnaire, occupational fatigue / burnout / recovery scale (OFER), sleep hygiene index (SHI) and World Health Organization quality of life scale (WHOQOL-BREF) questionnaires were answered by the participants.
Read the detailed description
Nordic Musculoskeletal Questionnaire: It is a scale that evaluates whether symptoms of pain, pain and discomfort have been experienced in the neck, shoulder, elbow, hand-wrist, waist, back, hip-thigh, knee-foot-ankle regions during the last 12 months and whether ordinary indoor and outdoor activities are hampered by these symptoms and whether there has been pain in the mentioned body areas for the last 7 days. It consists of 27 items and each item is answered as yes / no.
Occupational Fatigue Exhaustion Recovery Scale: It is a scale developed to measure occupational fatigue. It consists of 15 items in total and 3 sub-dimensions evaluating chronic fatigue (questions 1-5), acute fatigue (questions 6-10) and recovery (questions 11-15). Each item is scored between 0-6 points (0 = Strongly Disagree, 1 = Disagree, 2 = Somewhat Disagree, 3 = Neither agree nor disagree, 4 = slightly agree, 5 = Agree, 6 = Strongly Agree) by the participants. High scores in the chronic and acute fatigue sub-dimensions mean higher occupational fatigue, and higher scores in the recovery sub-dimension mean better recovery between working periods.
Sleep Hygiene Index: It is a scale that evaluates sleep hygiene. The frequencies of sleep hygiene-related behaviors are questioned in a total of 13 items with a Likert-type scale where each item is scored between 0 and 4 (0 = never, 1 = rarely, 3 = sometimes, 4 = often, 5 = always). Higher scores indicate worse sleep hygiene.
WHOQOL-BREF-TR: It is a scale that evaluates the well-being of individuals in 4 sub-areas in which physical health, psychological status, social relations and environmental conditions are questioned, and their general quality of life and health status with one question. Each item is scored on a 1-5 Likert-type scale. Sub-domain scores represent the quality of life in their field independently of each other. Higher scores indicate better quality of life.
- Conditions
- Pain in A Joint, Multiple Sites
- Being tested
- Survey
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey will be applied to the participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nordic Musculoskeletal Questionnaire scores
whether symptoms of pain, pain and discomfort have been experienced in the neck, shoulder, elbow, hand-wrist, waist, back, hip-thigh, knee-foot-ankle regions during the last 12 months and whether ordinary indoor and outdoor activities are hampered by these symptoms and whether there has been pain in the mentioned body areas for the last 7 days.
Measured: 1 month
Occupational Fatigue Exhaustion Recovery Scale scores
İt evaluates chronic fatigue, acute fatigue and recovery.
Measured: 1 month
Sleep Hygiene Index score
It evaluates sleep hygiene.
Measured: 1 month
WHOQOL-BREF-TR scores
It evaluates the well-being of individuals in physical health, psychological status, social relations and environmental conditions and their general quality of life and health status.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start20 Dec 2020
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain in A Joint, Multiple SitesStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 102 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
- NCT04742335
- Sponsor's protocol ID
- 2020-3-17
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain, Occupational Fatigue, Sleep and Quality of Life in Nurses
- ClinicalTrials.gov ID
- NCT04742335
- Acronym / sponsor ID
- 2020-3-17
- Conditions
- Pain in A Joint, Multiple Sites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 8 Feb 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 the study is to evaluate the pain, occupational fatigue, sleep and quality of life in nurses and the relationships between them. 102 participants working as nurses were included in the study. Data on age, gender, height, weight, working year in the profession, weekly working hours, hand dominance, diagnosed diseases and marital status of the participants were collected. Subsequently, the questions included in the Nordic musculoskeletal questionnaire, occupational fatigue / burnout / recovery scale (OFER), sleep hygiene index (SHI) and World Health Organization quality of life scale (WHOQOL-BREF) questionnaires were answered by the participants.
Detailed description
Nordic Musculoskeletal Questionnaire: It is a scale that evaluates whether symptoms of pain, pain and discomfort have been experienced in the neck, shoulder, elbow, hand-wrist, waist, back, hip-thigh, knee-foot-ankle regions during the last 12 months and whether ordinary indoor and outdoor activities are hampered by these symptoms and whether there has been pain in the mentioned body areas for the last 7 days. It consists of 27 items and each item is answered as yes / no.
Occupational Fatigue Exhaustion Recovery Scale: It is a scale developed to measure occupational fatigue. It consists of 15 items in total and 3 sub-dimensions evaluating chronic fatigue (questions 1-5), acute fatigue (questions 6-10) and recovery (questions 11-15). Each item is scored between 0-6 points (0 = Strongly Disagree, 1 = Disagree, 2 = Somewhat Disagree, 3 = Neither agree nor disagree, 4 = slightly agree, 5 = Agree, 6 = Strongly Agree) by the participants. High scores in the chronic and acute fatigue sub-dimensions mean higher occupational fatigue, and higher scores in the recovery sub-dimension mean better recovery between working periods.
Sleep Hygiene Index: It is a scale that evaluates sleep hygiene. The frequencies of sleep hygiene-related behaviors are questioned in a total of 13 items with a Likert-type scale where each item is scored between 0 and 4 (0 = never, 1 = rarely, 3 = sometimes, 4 = often, 5 = always). Higher scores indicate worse sleep hygiene.
WHOQOL-BREF-TR: It is a scale that evaluates the well-being of individuals in 4 sub-areas in which physical health, psychological status, social relations and environmental conditions are questioned, and their general quality of life and health status with one question. Each item is scored on a 1-5 Likert-type scale. Sub-domain scores represent the quality of life in their field independently of each other. Higher scores indicate better quality of life.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 102 volunteer nurses over 18 years old.
Key inclusion criteria (2 listed)
- Being over 18 years old
- Working as a nurse
Key exclusion criteria (3 listed)
- Being under the age of 18
- Having a history of serious trauma and orthopedic surgery in the last 1 year
- Having a chronic severe internal and neurological disease
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 will be applied to the participants. | Other | – |
Primary outcome
Nordic Musculoskeletal Questionnaire scores
Time frame: 1 month
whether symptoms of pain, pain and discomfort have been experienced in the neck, shoulder, elbow, hand-wrist, waist, back, hip-thigh, knee-foot-ankle regions during the last 12 months and whether ordinary indoor and outdoor activities are hampered by these symptoms and whether there has been pain in the mentioned body areas for the last 7 days.
Occupational Fatigue Exhaustion Recovery Scale scores
Time frame: 1 month
İt evaluates chronic fatigue, acute fatigue and recovery.
Sleep Hygiene Index score
Time frame: 1 month
It evaluates sleep hygiene.
WHOQOL-BREF-TR scores
Time frame: 1 month
It evaluates the well-being of individuals in physical health, psychological status, social relations and environmental conditions and their general quality of life and health status.
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 8 Feb 2021.
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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 Pain in A Joint, Multiple Sites, 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 2 inclusion and 3 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 8 Feb 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?
Nordic Musculoskeletal Questionnaire scores (time frame: 1 month). 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 8 Feb 2021.