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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
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mental Stress

Eligibility Criteria

17 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 15, 2023
    Last Updated
    May 25, 2023
    Sponsor
    Kafrelsheikh University
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    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

    Learn more about this trial

    Mental Stress on Balance

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