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- Ensaio Clínico NCT07816952
Young Adult Women and Wearable Posture Corrector Device
13 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
90
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Neslihan Nur Dursun
- Número de telefone: +90 543 929 64 85
- E-mail: neslihannurdursun@gmail.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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'Introductory Information Form'
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
1 de maio de 2027
Conclusão do estudo (Estimado)
1 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
8 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de setembro de 2026
Primeira postagem (Real)
14 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de setembro de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- E-60116787-020-805093
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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