Mental Stress on Balance
Primary Purpose
Mental Stress
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral and practical exam
Sponsored by
About this trial
This is an interventional basic science trial for Mental Stress
Eligibility Criteria
Inclusion Criteria: BMI between 20 and 30 free of any diseases Exclusion Criteria: any trauma within last 2 weeks
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mental stress group
Control group
Arm Description
they were expected to take their exams just after the assessment and before measuring for the second time
they were expected to take nothing for 30 min just after the assessment and before measuring for the second time
Outcomes
Primary Outcome Measures
Jerk in X,Y,Z
Captured by accelerometer readings
Swaying in X,Y,Z
Captured by Gyroscope readings
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05890937
Brief Title
Mental Stress on Balance
Official Title
Effect of Mental Stress on Balance in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Objectives:
This study aimed to examine the impact of mental stress on balance systems in healthy adults.
Study population & Sample size:
Participants were delimited to 178 students that enter oral and practical exams at different levels in Faculty of Physical Therapy, KafrEl-Sheikh University. Balance was measured using mini-SITCIB test before and after the exam. another 40 subject that have no exam were recruited to work as control group
Study Design :
it is a controlled trial.
Methods :
After obtaining the consent form, and demographics. The mobile application was opened, and a new experiment was created. Abdominal support was modified so it contains a pocket in its centre so the mobile can fit onto it. Participants were asked to conduct a mini-SITCIB test before and after the exam in experimental group and before and after 30 min in control group. The data was extracted and stored anonymously on the hard drive as CSV files.
Detailed Description
Mental health is a critical but often overlooked aspect of overall health. Research has shown that mental stress can have detrimental effects on physical health, including balance impairments, in healthy adults. Balance is a crucial physiological function that impacts daily activities and quality of life. Imbalance due to mental stress can increase the risk of falls, injuries, and other health issues, particularly in the aging population.
Objectives:
This study aimed to examine the impact of mental stress on balance systems in healthy adults.
Study population & Sample size:
Participants were delimited to 178 students that enter oral and practical exams at different levels in Faculty of Physical Therapy, KafrEl-Sheikh University. Balance was measured using mini-SITCIB test before and after the exam. another 40 subject that have no exam were recruited to work as control group
Study Design :
it is a controlled trial.
Methods :
After obtaining the consent form, and demographics. The mobile application was opened, and a new experiment was created. Abdominal support was modified so it contains a pocket in its centre so the mobile can fit onto it. Participants were asked to conduct a mini-SITCIB test before and after the exam in experimental group and before and after 30 min in control group. The data was extracted and stored anonymously on the hard drive as CSV files.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Stress
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mental stress group
Arm Type
Experimental
Arm Description
they were expected to take their exams just after the assessment and before measuring for the second time
Arm Title
Control group
Arm Type
No Intervention
Arm Description
they were expected to take nothing for 30 min just after the assessment and before measuring for the second time
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral and practical exam
Intervention Description
Oral and practical exam that performed at the end of the semester
Primary Outcome Measure Information:
Title
Jerk in X,Y,Z
Description
Captured by accelerometer readings
Time Frame
2 weeks
Title
Swaying in X,Y,Z
Description
Captured by Gyroscope readings
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI between 20 and 30
free of any diseases
Exclusion Criteria:
any trauma within last 2 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ali M Torad, PHD
Phone
+201008889975
Email
ahmed.ali.torad@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Mental Stress on Balance
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