- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Nurcan Contarli, PhD
- Telefonnummer: +90 370 418 9171
- E-Mail: nurcancontarli@karabuk.edu.tr
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
GERD patient group
Age between 18 and 65 years patient who has GERD
|
|
control group
Age between 18 and 65 years patient who has not GERD
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
Zeitfenster: 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
Zeitfenster: 1 day
|
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
|
|
Postural Analysis
Zeitfenster: 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
|
|
Visual Analog Scale (VAS)
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Erkrankungen des Bewegungsapparates
- Muskelerkrankungen
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Erkrankungen der Speiseröhre
- Motilitätsstörungen des Ösophagus
- Schluckstörungen
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- Anzeichen und Symptome
- Muskel-Skelett-Schmerzen
- Gastroösophagealer Reflux
- Motorik
Andere Studien-ID-Nummern
- KBU-FTR-NC-09
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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