Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05302453
Other study ID # 2021-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2021
Est. completion date October 1, 2022

Study information

Verified date February 2023
Source Bandirma Onyedi Eylül University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During the coronavirus disease (COVID-19) pandemic, stay-at-home isolation as a precaution to alleviate the disease has affected the physical and mental well-being of individuals. University students spent time in front of the screen with online education and developed a sedentary lifestyle during the academic term. In this process, musculoskeletal disorders increased more in university students due to the increase in the use of laptop or computer, smartphone, and social media. The COVID-19 pandemic has caused psychological disorders as well as physical health problems. General population studies have shown that all forms of depression, anxiety, stress, sleep problems, and psychological distress are highly increased during this period. In a study conducted in Turkey, it was reported that students' negative well-being, anxiety, and physical inactivity significantly affected perceived stress during the COVID-19 pandemic, and students' mental health was at high risk. It has been stated that providing mental health supportive systems in students and encouraging physical activity regularly can reduce perceived stress levels. On the other hand, psychological interventions via video conferencing platforms have been proposed to promote mental health due to the limited and delayed face-to-face healthcare as a result of the COVID-19 pandemic. It has been stated that the use of telemedicine or e-health applications together with body-mind approaches such as yoga, tai chi, qigong may be beneficial in order to encourage physical activity and protect mental health in this critical period. Basic Body Awareness Therapy (BBAT), which is among the body-mind approaches, is also frequently used in the rehabilitation of patients with psychiatric disorders, pain, and chronic musculoskeletal system problems. Therefore, the aim of this study is to evaluate the effect of BBAT on musculoskeletal disorders and psychological symptoms in university students who participated in the hybrid (online + face-to-face) education program during the COVID-19 pandemic. The importance of this study is that it is the first study on physical and psychological symptoms of BBAT in university students.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 1, 2022
Est. primary completion date June 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Being studying at Bandirma Onyedi Eylul University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation - Volunteering to participate in the study - Being between the ages of 18-25 Exclusion Criteria: - Having any diagnosed psychological disorder - Regularly doing body-mind approaches such as yoga and tai chi - Having any condition involving the musculoskeletal system - Having a rheumatic disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Basic Body Awareness Therapy
Basic Body Awareness Therapy (BBAT), which is among the body-mind approaches, is also frequently used in the rehabilitation of patients with psychiatric disorders, pain, and chronic musculoskeletal system problems.

Locations

Country Name City State
Turkey Bandirma Onyedi Eylul University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation Balikesir

Sponsors (1)

Lead Sponsor Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bravo C, Skjaerven LH, Espart A, Guitard Sein-Echaluce L, Catalan-Matamoros D. Basic Body Awareness Therapy in patients suffering from fibromyalgia: A randomized clinical trial. Physiother Theory Pract. 2019 Oct;35(10):919-929. doi: 10.1080/09593985.2018.1467520. Epub 2018 May 3. — View Citation

Chen B, Sun J, Feng Y. How Have COVID-19 Isolation Policies Affected Young People's Mental Health? - Evidence From Chinese College Students. Front Psychol. 2020 Jun 24;11:1529. doi: 10.3389/fpsyg.2020.01529. eCollection 2020. — View Citation

Seferiadis A, Ohlin P, Billhult A, Gunnarsson R. Basic body awareness therapy or exercise therapy for the treatment of chronic whiplash associated disorders: a randomized comparative clinical trial. Disabil Rehabil. 2016;38(5):442-51. doi: 10.3109/09638288.2015.1044036. Epub 2015 May 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) The Turkish reliability and validity studies of the questionnaire developed by Cornell University were performed by Erdinc et al. The CMDQ measures the frequency of pain or discomfort in 11 different body parts in the past seven days, the severity of this situation, and its interference on the ability to work.For frequency in scoring the scale: "never: 0 points, 1-2 times last week: 1.5 points, 3-4 times last week: 3.5 points, once every day: 5 points, several times every day: 10 points are taken. For severity: slightly uncomfortable: 1 point, moderately uncomfortable: 2 points, very uncomfortable: 3 points. For the interference on the ability to work: not at all: 1 point, slightly interfered: 2 points, substantially interfered: 3 points. Higher scores mean a worse outcome. Baseline
Primary Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) The Turkish reliability and validity studies of the questionnaire developed by Cornell University were performed by Erdinc et al. The CMDQ measures the frequency of pain or discomfort in 11 different body parts in the past seven days, the severity of this situation, and its interference on the ability to work.For frequency in scoring the scale: "never: 0 points, 1-2 times last week: 1.5 points, 3-4 times last week: 3.5 points, once every day: 5 points, several times every day: 10 points are taken. For severity: slightly uncomfortable: 1 point, moderately uncomfortable: 2 points, very uncomfortable: 3 points. For the interference on the ability to work: not at all: 1 point, slightly interfered: 2 points, substantially interfered: 3 points. Higher scores mean a worse outcome. 12th week
Primary Brief Symptom Inventory (BSI) (53 items) Sahin & Durak found that the inventory developed by Derogatis is valid and reliable in determining the psychological problems of university students. It has been stated that it is a useful inventory in screening studies of university students' mental health. It is a 53-item self-assessment inventory. BSI uses a 5-point Likert scale, ranging from 0 ("not at all") to 4 ("extremely"). Higher scores mean a worse outcome Baseline
Primary Brief Symptom Inventory (BSI) (53 items) Sahin & Durak found that the inventory developed by Derogatis is valid and reliable in determining the psychological problems of university students. It has been stated that it is a useful inventory in screening studies of university students' mental health. It is a 53-item self-assessment inventory. BSI uses a 5-point Likert scale, ranging from 0 ("not at all") to 4 ("extremely"). Higher scores mean a worse outcome 12th week
See also
  Status Clinical Trial Phase
Completed NCT05065723 - Investigation of the Effect of Internet Addiction Level in University Students
Completed NCT05031988 - Determinants of Physical Activity and Mental Health During and After Covid-19 Lockdown
Completed NCT05882409 - Education Given on Their Attitudes Towards Violence Against Women and Their Conflict N/A
Recruiting NCT05929430 - Mindfulness in University Students. ATENEU Program N/A
Completed NCT06028243 - Awareness Model in Prevention of Osteoporosis N/A
Recruiting NCT06112158 - The Effect of Web-Assisted Peer Education for Early Diagnosis of Breast Cancer on Health Beliefs, Knowledge Levels and Breast Self-Examination in University Students N/A
Completed NCT05847335 - Childhood Traumas, and Personality Beliefs and Emotional Intelligence
Recruiting NCT06376032 - EndeavorOTC® Research Study in College Students N/A
Recruiting NCT06333444 - Counselling Intervention for College Students Experienced Psychological Distress N/A
Completed NCT02593617 - The Effect of Energy Drink Consumption on Alcohol-Substance Use and It's Relationship With Impulsivity In University Students N/A
Recruiting NCT06406283 - Active Young, Healthy Mind. The YoungFitT Project N/A
Completed NCT04258540 - The Effects of Yoga on Student Mental Health N/A