- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07816952
Young Adult Women and Wearable Posture Corrector Device
13 september 2026 uppdaterad av: Neslihan Nur Dursun, Pamukkale University
The Effect of a Wearable Posture Corrector Device on Back Pain, Body Image, and Postural Awareness in Young Adult Women
To improve posture, methods such as strengthening specific muscles or focusing on body alignment are commonly used.
In addition to elastic posture correctors, electronic posture reminders can also be utilized.
Thanks to current wearable technologies and their companion mobile apps, individuals can enhance their posture awareness.
Although studies show that wearable technologies effectively foster posture awareness, the effects of wearable posture-correcting devices on back pain (VAS) and body image are not sufficiently known.
This study aims to examine the effects of a wearable posture-correcting device on back pain, body image, and posture awareness to improve posture in young adult women.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Detaljerad beskrivning
This study is a randomized controlled experimental trial with pretest-posttest measurements in experimental and control groups.
The study will be conducted with young adult female students.
The sample size was calculated using the G*Power software, based on a similar study that utilized the same scale (VAS).
In the a priori power analysis, based on an independent samples t-test with 80% power, an alpha level of 0.05, and an effect size of 0.56, a total of 82 participants-41 in the experimental group and 41 in the control group-were required.
Considering potential sample dropouts, the sample size was increased by at least 10% and finalized at a total of 90 participants.Female participants who apply to join the study, express their willingness to use the wearable posture-correcting device, and meet the inclusion criteria will be randomly assigned to the experimental and control groups according to their order of application.
Data will be collected using an 'Introductory Information Form', the 'VAS' to assess back pain, the 'Body Image Scale', and the 'Postural Awareness Scale'.Data analysis will be performed using the SPSS 31.0 software package.
The test of significance of the difference between two means (independent samples t-test) will be utilized to reveal the differences between the two independent groups.
A significance level of alpha 0.05 will be accepted.
Studietyp
Interventionell
Inskrivning (Beräknad)
90
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Neslihan Nur Dursun
- Telefonnummer: +90 543 929 64 85
- E-post: neslihannurdursun@gmail.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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'Introductory Information Form'
Tidsram: 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)
Tidsram: 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.
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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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Body Image Scale
Tidsram: It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
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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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 maj 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
8 september 2026
Först inskickad som uppfyllde QC-kriterierna
10 september 2026
Första postat (Faktisk)
14 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 september 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- E-60116787-020-805093
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