Mental Stress on Balance | NCT05890937

Studies
Mental Stress on Balance

NCT05890937

Sponsor

Kafrelsheikh University

Status

Completed

Last Update Posted

Apr 6, 2025Actual

Enrollment

400Actual

Phase

Not Applicable

Conditions

Mental Stress

Interventions

Oral and practical exam

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2023Actual

Primary Completion Date

Feb 20, 2025Actual

Completion Date

Feb 20, 2025Actual

First Submitted Date

May 15, 2023

First Submission Date that Met QC Criteria

May 25, 2023

First Posted Date

Jun 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2025

Last Update Posted Date

Apr 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Ali Mohammed Torad, Lecturer, Kafrelsheikh UniversityPrincipal Investigator

Lead Sponsor

Kafrelsheikh UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

Study Design :

it is a controlled trial.

Methods :

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mental stress group	Experimental	they were expected to take their exams just after the assessment and before measuring for the second time	Diagnostic Test: Oral and practical exam
Control group	No Intervention	they were expected to take nothing for 30 min just after the assessment and before measuring for the second time

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral and practical exam	Diagnostic Test	Oral and practical exam that performed at the end of the semester	Mental stress group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Jerk in X,Y,Z	Captured by accelerometer readings	2 weeks
Swaying in X,Y,Z	Captured by Gyroscope readings	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI between 20 and 30
free of any diseases

Exclusion Criteria:

any trauma within last 2 weeks

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

22 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kafrelsheikh university		Kafrelsheikh			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided