- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07816952
Young Adult Women and Wearable Posture Corrector Device
13. september 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Neslihan Nur Dursun
- Telefonnummer: +90 543 929 64 85
- E-mail: neslihannurdursun@gmail.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
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.
|
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.
|
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
'Introductory Information Form'
Tidsramme: Baseline
|
This form, prepared by the researchers in accordance with the literature, consists of 9 questions containing the sociodemographic data of women.
|
Baseline
|
|
VAS (Back Pain)
Tidsramme: It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
|
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
|
|
Body Image Scale
Tidsramme: 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.
|
It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
|
|
Postural Awareness Scale
Tidsramme: It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
|
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.
|
It will be administered simultaneously to participants in both the experimental and control groups at baseline and 4-weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. juni 2027
Datoer for studieregistrering
Først indsendt
8. september 2026
Først indsendt, der opfyldte QC-kriterier
10. september 2026
Først opslået (Faktiske)
14. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. september 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E-60116787-020-805093
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .