NCT05302453

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

March 13, 2022

Last Update Submit

February 13, 2023

Conditions

Keywords

Basic Body Awareness TherapyCOVID-19Musculoskeletal Paintelerehabilitationmental health

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

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.

Interventions

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.

Basic Body Awareness Therapy Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandirma Onyedi Eylul University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Balıkesir, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 32670172BACKGROUND
  • 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.

    PMID: 29723080BACKGROUND
  • 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.

    PMID: 25955823BACKGROUND
  • Yuce 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. 2025 Sep 25:10538127251378088. doi: 10.1177/10538127251378088. Online ahead of print.

MeSH Terms

Conditions

COVID-19Musculoskeletal PainPsychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMuscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 31, 2022

Study Start

March 11, 2021

Primary Completion

June 11, 2021

Study Completion

October 1, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations