Young Adult Women and Wearable Posture Corrector Device
The Effect of a Wearable Posture Corrector Device on Back Pain, Body Image, and Postural Awareness in Young Adult Women
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Neslihan Nur Dursun
- Phone Number: +90 543 929 64 85
- Email: neslihannurdursun@gmail.com
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Who are studying at *** University
- Women aged 18-25 years
- Women without spinal deformities,
- No history of spinal surgery,
- Back pain rated as VAS ≥ 3,
- A Postural Awareness Scale score of ≤ 46,
- No diagnosed psychiatric disorders,
- No dermatological conditions that would prevent the use of the device
Exclusion Criteria:
- Not being a student at *** University
- Age < 18 or > 25 years
- Presence of spinal deformity
- Previous spinal surgery
- Back pain VAS score < 3
- Postural Awareness Scale score > 46
- Diagnosed psychiatric illness
- Dermatological conditions preventing device use
- Male sex / gender
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Active Comparator: Experimental Group
A pretest will be administered to all participating women using the 'Introductory Information Form', the 'VAS' to evaluate back pain, the 'Body Image Scale' , and the 'Postural Awareness Scale'.
Women in the experimental group will be provided with the wearable posture corrector device and instructed on how to use it.
Following the completion of the intervention period, the posttest will be conducted by re-administering the 'VAS', 'Body Image Scale', and 'Postural Awareness Scale' to the experimental group.
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The planned device is designed for general use, requires no prescription, does not serve a clinical diagnostic or therapeutic purpose, and can be used without the need to consult a healthcare professional.
The device is placed on the upper back during use.
When the user assumes an incorrect posture, the device emits gentle vibrations to alert them, thereby promoting posture awareness.
Women in the experimental group will use the device for a total of 4 weeks.
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No Intervention: Control Group
No intervention will be administered to the control group, and data will be collected using the same measurement instruments at the same time points.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
'Introductory Information Form'
Time Frame: Baseline
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This form, prepared by the researchers in accordance with the literature, consists of 9 questions containing the sociodemographic data of women.
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Baseline
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VAS (Back Pain)
Time Frame: It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
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It is a single-item, non-invasive, universally used visual analog measurement tool designed to determine pain perception.
It consists of a 100 mm horizontal line, numbered from 0 representing 'no pain' to 10 representing 'unbearable pain' at either end to indicate the severity of symptoms.
|
It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
|
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Body Image Scale
Time Frame: It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
|
The 'Body Image Scale' was developed by Saylan & Soyyiğit (2022) to evaluate body image in individuals during adolescence and emerging adulthood and was reported to be a valid and reliable instrument.
It is a 5-point Likert-type scale (1 = Strongly disagree to 5 = Strongly agree) consisting of 21 items.
It comprises four subdimensions: negative body perception, evaluation sensitivity, positive body perception, and body modification.
Five items of the scale (Items 4, 7, 15, 16, and 17) are reverse-scored, with the total score ranging from a minimum of 21 to a maximum of 105.
Higher scores obtained from the scale indicate a more negative body image.
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It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
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Postural Awareness Scale
Time Frame: It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
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The Turkish validity and reliability of the Postural Awareness Scale was conducted by Dursun and Önen (2018).
The purpose of the scale is to assess an individual's self-reported body posture awareness.
It is a 7-point Likert-type scale (ranging from 1 = 'not at all true for me' to 7 = 'completely true for me') consisting of 11 items.
Items 1, 2, 3, 4, 5, and 12 of the scale are reverse-scored, and the total score obtainable ranges from a minimum of 11 to a maximum of 77.
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It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- E-60116787-020-805093
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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