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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04954612
Other study ID # 2020/205
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date September 30, 2021

Study information

Verified date July 2021
Source Gaziosmanpasa Research and Education Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1225
Est. completion date September 30, 2021
Est. primary completion date July 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 13 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Children going to special education school

Study Design


Intervention

Other:
Questionnaire study (Cross-sectional analytical clinical research)
Questionnaire study (Cross-sectional analytical clinical research)

Locations

Country Name City State
Turkey Gaziosmanpasa Training and Research Hospital Istanbul Gaziosmanpasa

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Alaca 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. — View Citation

Gariepy 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.

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. — View Citation

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. — View Citation

Majumdar 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. — View Citation

Robbins M, Johnson I, Cunliffe CJCC. Encouraging good posture in school children using computers. 2009;12(1):35-44.

Simons 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of musculoskeletal pain Presence of musculoskeletal pain in one of the nine body parts One day
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