ChildrenNCT04954612
Musculoskeletal Problems in School Children During the COVID-19 Pandemic
An observational study of Children and Musculoskeletal Disorder, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
During COVID-19 pandemic, in the lockdown period, reduced physical activity and obesity were reported in children. In Turkey, face to face education was ceased after March 16, till the end of the previous academic year and education was tried to be substituted remotely. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Musculoskeletal Disorder
- What is being tested?
- Questionnaire study (Cross-sectional analytical clinical research)
- How many people
- 1,225 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 30 Sep 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A sample size of 1225 participants was calculated by assuming a musculoskeletal pain prevalence of 15% among children between the ages 6-13, with a confidence limit of 95% with a margin of error 2%.
Who may be able to join
- Being parent or guardian of a child between the ages of 6-13 years
- Having access to the Internet
- Being literate
- Giving consent to participate in the study
Who cannot join
- Children going to special education school
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul, Gaziosmanpasa, 34255
About this study
Official title: Musculoskeletal Problems and Associated Factors in Children Aged Between 6-13 Years During the COVID-19 Pandemic
During COVID-19 pandemic, in the lockdown period, reduced physical activity and obesity were reported in children.
In Turkey, face to face education was ceased after March 16, till the end of the previous academic year and education was tried to be substituted remotely.
Read more
A temporary lockdown was implemented for children and young people under the age of 20, between April 3 and June 5 2020. At 45 days following the lockdown of children, 72% of the parents with children aged 6-13 years stated that their screen time had increased to a mean of 6.4 hours per day.
Engaging more time in physical activity, and less in sedentary and leisure screen time was found to be associated with less anxiety during pandemic.
Before 2020-2021 academic year, government and educators increased their preparedness for the second and third waves and improved the technological infrastructure. Depending on grades, preferences of the family, primary education continued remotely between November 2020 and July 2021.
The aim of this study is to investigate whether musculoskeletal complaints are increased in school-age children during the pandemics and whether there is a relationship between the decreased level of physical activity, increased screen time, poor posture and musculoskeletal complaints.
Read the detailed description
A survey assessing musculoskeletal pain in children in the last 1 month, and associated factors including presence of non-ergonomic postures during online education was structured by two physiatrists and a public health specialist after the review of the relevant literature. Several paediatric pain and musculoskeletal assessment tools were reviewed.
The survey consisted of a total of 66 questions including sociodemographic characteristics of the children and family (17 items), education hours, used technological device (7 items), screen time and physical activity (5 items), presence of musculoskeletal pain (27 items) and ergonomics (10 items).
Questions regarding the musculoskeletal pain were constructed based on The Nordic musculoskeletal questionnaire extended version (NMQ-E) which was translated and validated into Turkish. Pain or discomfort questions experienced in the nine body parts with binary choices (yes or no) were used. The figure in NMQ-E was used to describe body regions (the neck, shoulder, upper back, elbow, wrist/hand, low back, hip/ thigh, knee, ankle/foot) and pain questions were structured accordingly on this body diagram.
The questionnaire was created using the Qualtrics program. The survey was piloted among ten participants to ensure its readability and ease of completion. After obtaining permissions from Ministry of National Education of Turkey, survey link was shared with the school principles so that they distributed the survey to the guardians of children via smart phones or email. The survey will be available during two months and a reminder will be sent once a week.
- Conditions
- Children, Musculoskeletal Disorder
- Being tested
- Questionnaire study (Cross-sectional analytical clinical research)
- Keywords
- COVID-19, Remote education, Ergonomics
- Medical subject headings
- Musculoskeletal Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire study (Cross-sectional analytical clinical research)Other
Questionnaire study (Cross-sectional analytical clinical research)
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of musculoskeletal pain
Presence of musculoskeletal pain in one of the nine body parts
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 May 2021
- Primary completion9 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies 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
- 1,225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Özden Özyemişçi Taşkıran, Prof, Principal investigator, Koc University School of Medicine Department of Physical Medicine and RehabilitationSibel Sakarya, Prof, Study director, Koc University School of Medicine Department of Infectious DiseaseZeynep Turan, Study chair, Koc University School of Medicine Department of Physical Medicine and RehabilitationEsra Giray, Assoc Prof, Study chair, Koc University School of Medicine Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954612
- Sponsor's protocol ID
- 2020/205
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamper SJ, Henschke N, Hestbaek L, Dunn KM, Williams CM. Musculoskeletal pain in children and adolescents. Braz J Phys Ther. 2016 Feb 16;20(3):275-84. doi: 10.1590/bjpt-rbf.2014.0149.
PubMed 27437719Alaca N, Safran EE, Karamanlargil AI, Timucin E. Translation and cross-cultural adaptation of the extended version of the Nordic musculoskeletal questionnaire into Turkish. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):472-481.
PubMed 31789298Simons LE, Smith A, Ibagon C, Coakley R, Logan DE, Schechter N, Borsook D, Hill JC. Pediatric Pain Screening Tool: rapid identification of risk in youth with pain complaints. Pain. 2015 Aug;156(8):1511-1518. doi: 10.1097/j.pain.0000000000000199.
PubMed 25906349Gariepy G, McKinnon B, Sentenac M, Elgar FJJCIR. Validity and reliability of a brief symptom checklist to measure psychological health in school-aged children. 2016;9(2):471-484.
Lauridsen HH, Hestbaek L. Development of the young spine questionnaire. BMC Musculoskelet Disord. 2013 Jun 12;14:185. doi: 10.1186/1471-2474-14-185.
PubMed 23758965Majumdar P, Biswas A, Sahu S. COVID-19 pandemic and lockdown: cause of sleep disruption, depression, somatic pain, and increased screen exposure of office workers and students of India. Chronobiol Int. 2020 Aug;37(8):1191-1200. doi: 10.1080/07420528.2020.1786107. Epub 2020 Jul 13.
PubMed 32660352Robbins M, Johnson I, Cunliffe CJCC. Encouraging good posture in school children using computers. 2009;12(1):35-44.
Tan A, Strauss VY, Protheroe J, Dunn KM. Epidemiology of paediatric presentations with musculoskeletal problems in primary care. BMC Musculoskelet Disord. 2018 Feb 6;19(1):40. doi: 10.1186/s12891-018-1952-7.
PubMed 29409492
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Problems and Associated Factors in Children Aged Between 6-13 Years During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04954612
- Acronym / sponsor ID
- 2020/205
- Conditions
- Children, Musculoskeletal Disorder
- Keywords
- COVID-19, Remote education, Ergonomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,225 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 9 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 8 Jul 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.
During COVID-19 pandemic, in the lockdown period, reduced physical activity and obesity were reported in children.
In Turkey, face to face education was ceased after March 16, till the end of the previous academic year and education was tried to be substituted remotely.
A temporary lockdown was implemented for children and young people under the age of 20, between April 3 and June 5 2020. At 45 days following the lockdown of children, 72% of the parents with children aged 6-13 years stated that their screen time had increased to a mean of 6.4 hours per day.
Engaging more time in physical activity, and less in sedentary and leisure screen time was found to be associated with less anxiety during pandemic.
Before 2020-2021 academic year, government and educators increased their preparedness for the second and third waves and improved the technological infrastructure. Depending on grades, preferences of the family, primary education continued remotely between November 2020 and July 2021.
The aim of this study is to investigate whether musculoskeletal complaints are increased in school-age children during the pandemics and whether there is a relationship between the decreased level of physical activity, increased screen time, poor posture and musculoskeletal complaints.
Detailed description
A survey assessing musculoskeletal pain in children in the last 1 month, and associated factors including presence of non-ergonomic postures during online education was structured by two physiatrists and a public health specialist after the review of the relevant literature. Several paediatric pain and musculoskeletal assessment tools were reviewed.
The survey consisted of a total of 66 questions including sociodemographic characteristics of the children and family (17 items), education hours, used technological device (7 items), screen time and physical activity (5 items), presence of musculoskeletal pain (27 items) and ergonomics (10 items).
Questions regarding the musculoskeletal pain were constructed based on The Nordic musculoskeletal questionnaire extended version (NMQ-E) which was translated and validated into Turkish. Pain or discomfort questions experienced in the nine body parts with binary choices (yes or no) were used. The figure in NMQ-E was used to describe body regions (the neck, shoulder, upper back, elbow, wrist/hand, low back, hip/ thigh, knee, ankle/foot) and pain questions were structured accordingly on this body diagram.
The questionnaire was created using the Qualtrics program. The survey was piloted among ten participants to ensure its readability and ease of completion. After obtaining permissions from Ministry of National Education of Turkey, survey link was shared with the school principles so that they distributed the survey to the guardians of children via smart phones or email. The survey will be available during two months and a reminder will be sent once a week.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A sample size of 1225 participants was calculated by assuming a musculoskeletal pain prevalence of 15% among children between the ages 6-13, with a confidence limit of 95% with a margin of error 2%.
Key inclusion criteria (4 listed)
- Being parent or guardian of a child between the ages of 6-13 years
- Having access to the Internet
- Being literate
- Giving consent to participate in the study
Key exclusion criteria (1 listed)
- Children going to special education school
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 |
|---|---|---|
| Questionnaire study (Cross-sectional analytical clinical research)Questionnaire study (Cross-sectional analytical clinical research) | Other | – |
Primary outcome
Presence of musculoskeletal pain
Time frame: One day
Presence of musculoskeletal pain in one of the nine body parts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Results publication: PubMed 27437719Kamper SJ, Henschke N, Hestbaek L, Dunn KM, Williams CM. Musculoskeletal pain in children and adolescents. Braz J Phys Ther. 2016 Feb 16;20(3):275-84. doi: 10.1590/bjpt-rbf.2014.0149.
- Results publication: PubMed 31789298Alaca N, Safran EE, Karamanlargil AI, Timucin E. Translation and cross-cultural adaptation of the extended version of the Nordic musculoskeletal questionnaire into Turkish. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):472-481.
- Results publication: PubMed 25906349Simons LE, Smith A, Ibagon C, Coakley R, Logan DE, Schechter N, Borsook D, Hill JC. Pediatric Pain Screening Tool: rapid identification of risk in youth with pain complaints. Pain. 2015 Aug;156(8):1511-1518. doi: 10.1097/j.pain.0000000000000199.
- Results publicationGariepy G, McKinnon B, Sentenac M, Elgar FJJCIR. Validity and reliability of a brief symptom checklist to measure psychological health in school-aged children. 2016;9(2):471-484.
- Results publication: PubMed 23758965Lauridsen HH, Hestbaek L. Development of the young spine questionnaire. BMC Musculoskelet Disord. 2013 Jun 12;14:185. doi: 10.1186/1471-2474-14-185.
- Results publication: PubMed 32660352Majumdar P, Biswas A, Sahu S. COVID-19 pandemic and lockdown: cause of sleep disruption, depression, somatic pain, and increased screen exposure of office workers and students of India. Chronobiol Int. 2020 Aug;37(8):1191-1200. doi: 10.1080/07420528.2020.1786107. Epub 2020 Jul 13.
- Results publicationRobbins M, Johnson I, Cunliffe CJCC. Encouraging good posture in school children using computers. 2009;12(1):35-44.
- Results publication: PubMed 29409492Tan A, Strauss VY, Protheroe J, Dunn KM. Epidemiology of paediatric presentations with musculoskeletal problems in primary care. BMC Musculoskelet Disord. 2018 Feb 6;19(1):40. doi: 10.1186/s12891-018-1952-7.
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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.
Özden Özyemişçi Taşkıran, Prof principal investigator
Koc University School of Medicine Department of Physical Medicine and Rehabilitation
Sibel Sakarya, Prof study director
Koc University School of Medicine Department of Infectious Disease
Zeynep Turan study chair
Koc University School of Medicine Department of Physical Medicine and Rehabilitation
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 Children and Musculoskeletal Disorder, run by Gaziosmanpasa Research and Education Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 8 Jul 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?
Results are not available in the source record.
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?
Presence of musculoskeletal pain (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04954612, which also lists 8 linked publications.
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 Jul 2021.