- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nurcan Contarli, PhD
- Número de teléfono: +90 370 418 9171
- Correo electrónico: nurcancontarli@karabuk.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
Periodo de tiempo: 1 day
|
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
Periodo de tiempo: 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
Periodo de tiempo: 1 day
|
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)
Periodo de tiempo: 1 day
|
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
|
|
International Physical Activity Questionnaire (IPAQ)
Periodo de tiempo: 1 day
|
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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades musculoesqueléticas
- Enfermedades Musculares
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades esofágicas
- Trastornos de la motilidad esofágica
- Trastornos de la deglución
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Dolor musculoesquelético
- Reflujo gastroesofágico
- Actividad del motor
Otros números de identificación del estudio
- KBU-FTR-NC-09
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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