University StudentsNCT05302453
The Effect of Basic Body Awareness Therapy on Musculoskeletal Disorders and Psychological Symptoms
A study testing Basic Body Awareness Therapy in people with University Students, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- University Students
- What is being tested?
- Basic Body Awareness Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2021to 1 Oct 2022
- Phase
- Interventional
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandirma Onyedi Eylul University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Balıkesir
About this study
Official title: The Effect of Basic Body Awareness Therapy on Musculoskeletal Disorders and Psychological Symptoms in University Students Participating in the Hybrid Education Program During the COVID-19 Pandemic Process
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.
- Conditions
- University Students
- Being tested
- Basic Body Awareness Therapy
- Keywords
- Basic Body Awareness Therapy, COVID-19, Musculoskeletal Pain, telerehabilitation, mental health
- Medical subject headings
- COVID-19, Musculoskeletal Pain, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Body Awareness TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Basic Body Awareness Therapy Group | Experimental | BBAT exercises to the participants in the study group, were performed under the leadership of two physiotherapists with internationally valid training certificates. In the face-to-face training, BBAT exercises were taught to the participants. Then the training went on via Google Meet. The lying exercises were shown on one participant before each group study and participants were asked to do lying exercises at home. Sitting and lying exercises were performed as a hybrid at one hour/in a week for 12 weeks. At the beginning and end of each group training, feedback was received from the participants' own experiences of the effects of the exercises on the body, emotions, and thoughts. Receives: Other: Basic Body Awareness Therapy |
| Control Group | No intervention | The Control group was warned to continue with daily routines and not to take any training that includes body-mind approaches such as yoga or Tai chi for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 12th week
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
Measured: Baseline
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
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start11 Mar 2021
- Primary completion11 Jun 2021
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for University StudentsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamiyet Yuce, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302453
- Sponsor's protocol ID
- 2021-1
- Status last verified
- Feb 2023
- First submitted
- 13 Mar 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32670172Bravo 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.
PubMed 29723080Seferiadis 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.
PubMed 25955823Yuce H, Kecelioglu S, Akcay B, Yilmaz FN. Effects of basic body awareness therapy via hybrid telerehabilitation on musculoskeletal and psychological symptoms in university students: A single-blind randomized controlled trial. J Back Musculoskelet Rehabil. 2026 Mar;39(2):477-490. doi: 10.1177/10538127251378088. Epub 2025 Sep 25.
PubMed 40997245
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Basic Body Awareness Therapy on Musculoskeletal Disorders and Psychological Symptoms in University Students Participating in the Hybrid Education Program During the COVID-19 Pandemic Process
- ClinicalTrials.gov ID
- NCT05302453
- Acronym / sponsor ID
- 2021-1
- Conditions
- University Students
- Keywords
- Basic Body Awareness Therapy, COVID-19, Musculoskeletal Pain, telerehabilitation, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 31 Mar 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic Body Awareness Therapy Group | Experimental | Other: Basic Body Awareness TherapyBBAT exercises to the participants in the study group, were performed under the leadership of two physiotherapists with internationally valid training certificates. In the face-to-face training, BBAT exercises were taught to the participants. Then the training went on via Google Meet. The lying exercises were shown on one participant before each group study and participants were asked to do lying exercises at home. Sitting and lying exercises were performed as a hybrid at one hour/in a week for 12 weeks. At the beginning and end of each group training, feedback was received from the participants' own experiences of the effects of the exercises on the body, emotions, and thoughts. |
| Control Group | No intervention | –The Control group was warned to continue with daily routines and not to take any training that includes body-mind approaches such as yoga or Tai chi for 12 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Basic Body Awareness TherapyBasic 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. | Other | Basic Body Awareness Therapy Group |
Primary outcome
Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)
Time frame: Baseline
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.
Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)
Time frame: 12th week
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.
Brief Symptom Inventory (BSI) (53 items)
Time frame: Baseline
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
Brief Symptom Inventory (BSI) (53 items)
Time frame: 12th week
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
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 14 Feb 2023.
- Background: PubMed 32670172Chen 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.
- Background: PubMed 29723080Bravo 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.
- Background: PubMed 25955823Seferiadis 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.
- Derived from this study: PubMed 40997245Yuce H, Kecelioglu S, Akcay B, Yilmaz FN. Effects of basic body awareness therapy via hybrid telerehabilitation on musculoskeletal and psychological symptoms in university students: A single-blind randomized controlled trial. J Back Musculoskelet Rehabil. 2026 Mar;39(2):477-490. doi: 10.1177/10538127251378088. Epub 2025 Sep 25.
- 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?
A study testing Basic Body Awareness Therapy in people with University Students, run by Bandırma Onyedi Eylül 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 3 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 14 Feb 2023. 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?
Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT05302453, which also lists 4 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 14 Feb 2023.