- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07643779
Symptom Severity, Posture, Pain, and Physical Activity in Gastroesophageal Reflux Disease
Investigation of Symptom Severity, Posture, Musculoskeletal Pain, and Physical Activity Levels in Patients With Gastroesophageal Reflux Disease
Panoramica dello studio
Stato
Descrizione dettagliata
Symptom severity will be assessed using the GERD-Q and PROMIS GERD scales. Postural assessment will be performed using the Posture Screen Lite application. Musculoskeletal pain will be evaluated with the Visual Analog Scale (VAS) and a body diagram, while physical activity levels will be measured using the International Physical Activity Questionnaire (IPAQ).
The aim of the study is to determine whether GERD is associated not only with gastrointestinal symptoms but also with functional parameters such as posture, pain, and physical activity level.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Nurcan Contarli, PhD
- Numero di telefono: +90 370 418 9171
- Email: nurcancontarli@karabuk.edu.tr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Being diagnosed with gastroesophageal reflux disease (GERD)
- Age between 18 and 65 years
- Willingness to participate in the study assessments
Exclusion Criteria:
- Presence of a diagnosed psychiatric disorder
- Pregnancy or breastfeeding status
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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GERD patient group
Age between 18 and 65 years patient who has GERD
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control group
Age between 18 and 65 years patient who has not GERD
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
Lasso di tempo: 1 day
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The GERD-Q is a six-item Likert-type questionnaire that assesses the frequency of GERD-related symptoms over the past week.
The first four items evaluate symptom frequency and are used for the diagnosis of the disease and monitoring treatment response.
The remaining two items assess the impact of the disease on daily life, including over-the-counter medication use and sleep disturbance.
Each item is scored on a four-point scale ranging from 0 to 3 according to symptom frequency.
In items 1, 2, 5, and 6, scores increase from 0 to 3 with increasing symptom frequency, whereas in items 3 and 4, scoring is reversed.
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1 day
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PROMIS GERD Scale
Lasso di tempo: 1 day
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The PROMIS GERD scale consists of 13 items.
Each item is scored on a scale ranging from 0 to 4 points, and the total score is obtained by summing all item scores.
According to the original scoring system, a score of 0 indicates no symptoms, scores of 1-3 indicate minimal symptoms, scores of 4-7 indicate mild symptoms, scores of 8-15 indicate moderate symptoms, and scores of 16 and above indicate severe symptoms.
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1 day
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Postural Analysis
Lasso di tempo: 1 day
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Posture Screen Lite is a posture analysis, body composition, and movement assessment software designed for use on iOS and Android devices with built-in camera systems.
In this study, posture will be assessed using the iPad-based Posture Screen Lite application.
Participants will be assessed wearing appropriate clothing that leaves the upper trunk and lower legs exposed.
Photographs will be taken from anterior, posterior, and right and left lateral views using a smartphone, without placing reference markers on the participant beforehand.
The captured images will then be analyzed using the Posture Screen Lite software by identifying anatomical reference points on the photographs.
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1 day
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Visual Analog Scale (VAS)
Lasso di tempo: 1 day
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The Visual Analog Scale (VAS) will be used to assess pain intensity.
VAS has been shown to be a valid and reliable method that is sensitive to small changes in clinical pain and treatment-related pain intensity.
Participants will be asked to indicate their pain level on a 10-cm horizontal line, ranging from "0" (no pain) to "10" (worst imaginable pain).
In addition, participants will mark the location(s) of their pain on a body diagram to determine pain distribution and localization.
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1 day
|
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International Physical Activity Questionnaire (IPAQ)
Lasso di tempo: 1 day
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The International Physical Activity Questionnaire (IPAQ) was developed by Craig et al. (2003) to assess physical activity levels.
The short form consists of seven items and evaluates physical activity performed during the last seven days.
Only activities lasting at least 10 minutes at a time are considered.
Participants report the duration (in minutes) of vigorous activities (e.g., weight lifting, fast cycling, aerobic exercises, team sports), moderate activities (e.g., table tennis, folk dances, light load carrying), and walking.
These values are converted into metabolic equivalent (MET) scores, and total physical activity level is calculated as MET-min/week.
Based on the results, participants can be classified as inactive, minimally active, or highly active.
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1 day
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie muscoloscheletriche
- Malattie muscolari
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Malattie esofagee
- Disturbi della motilità esofagea
- Disturbi della deglutizione
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Dolore muscoloscheletrico
- Reflusso gastroesofageo
- Attività motoria
Altri numeri di identificazione dello studio
- KBU-FTR-NC-09
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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