Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-30 @ 4:59 AM
Study NCT ID:
NCT07045792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Awareness Therapy in High Stressed Young Adults: Effects on Function, Balance, Sleep and Mood
Sponsor:
Mustafa Kemal University
Organization:
Study Overview
Official Title:
Investigating the Effects of Body Awareness Therapy on Functional Capacity, Balance, Sleep Quality and Psychological State in Young Adults With High Stress Levels: A Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Body Awareness Therapy (BAT) is a holistic approach to human movement that considers the physical, physiological, psychological, and existential aspects of human existence. This planned randomized controlled study will be conducted on young adults with high stress levels. One group will be subjected to BAT and the other group will be the control group. The BAT exercises will be performed in supine, sitting and standing positions. In the BAT group, the exercises will be performed as a group exercise, not individually. After the initial evaluations in both the BAT and control groups, a re-evaluation will be performed at the end of 8 weeks. Functional capacity will be assessed with the 6-minute walk test, static balance with the single-leg balance test (eyes open-eyes closed), dynamic balance with the Y-balance test, psychological status with the Depression-Anxiety-Stress Scale-21 (DASS-21), and sleep quality with the Pittsburgh Sleep Quality Scale. BAT will be performed 2 days per week for 8 weeks and will be continued progressively. This study will examine the effects of BaT on functional capacity, balance, sleep quality, and psychological state in young adults with high stress levels.
Detailed Description:
This study will follow a randomized controlled trial design. The study will be conducted in young adults at the Faculty of Health Sciences, Hatay Mustafa Kemal University.
The estimation of the sample size was conducted by calculating the requirement of a sample of 52 participants (26 per group) to achieve 80% power with an effect size of d = 0.80, α = 0.05, type I error, and β = 0.20, type II error. To account for potential exclusions from the study and data loss during the implementation process, the reserve participant rate was calculated to be 20%. Therefore, following the analysis, it was determined that the study would be conducted with a total of 62 participants, with 31 participants allocated to each group.
All assessments will be conducted in person by the research team. A comprehensive evaluation of the descriptive information, functional capacity, balance, sleep quality, and psychological status of the study participants is warranted.
Treatment Program Individuals in the BAT group will train 2 days per week for 8 weeks. The training will be conducted by a person who has received BAT training at levels A, B, C and D at the Swedish Institute of Body Awareness (Institutet Basal Kroppskännedom).
Those in the control group will not receive any training and will remain on the waiting list. These patients will also be assessed at baseline and after 8 weeks. In this group, BAT will be applied to the students who want to receive the training after the last measurements.
Body Awareness Therapy Exercises consist of awareness exercises in the supine, sitting, standing, and walking positions: Considering eight weeks, the training is designed to progress gradually after every two weeks. The BAT exercises are done in groups of 6 people.
The BAT program consists of 40 minutes of exercise.
The estimation of the sample size was conducted by calculating the requirement of a sample of 52 participants (26 per group) to achieve 80% power with an effect size of d = 0.80, α = 0.05, type I error, and β = 0.20, type II error. To account for potential exclusions from the study and data loss during the implementation process, the reserve participant rate was calculated to be 20%. Therefore, following the analysis, it was determined that the study would be conducted with a total of 62 participants, with 31 participants allocated to each group.
All assessments will be conducted in person by the research team. A comprehensive evaluation of the descriptive information, functional capacity, balance, sleep quality, and psychological status of the study participants is warranted.
Treatment Program Individuals in the BAT group will train 2 days per week for 8 weeks. The training will be conducted by a person who has received BAT training at levels A, B, C and D at the Swedish Institute of Body Awareness (Institutet Basal Kroppskännedom).
Those in the control group will not receive any training and will remain on the waiting list. These patients will also be assessed at baseline and after 8 weeks. In this group, BAT will be applied to the students who want to receive the training after the last measurements.
Body Awareness Therapy Exercises consist of awareness exercises in the supine, sitting, standing, and walking positions: Considering eight weeks, the training is designed to progress gradually after every two weeks. The BAT exercises are done in groups of 6 people.
The BAT program consists of 40 minutes of exercise.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: