Gastroesophageal Reflux Disease (GERD)NCT07643779
Symptom Severity, Posture, Pain, and Physical Activity in Gastroesophageal Reflux Disease
An observational study of Gastroesophageal Reflux Disease (GERD) and Symptom, run by Karabuk University.
Trial summary
This study is a cross-sectional research designed to investigate symptom severity, posture, musculoskeletal pain, and physical activity levels in individuals with gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD), Symptom, Musculoskeletal Pain
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with and without Gastroesophageal Reflux Disease
Who may be able to join
- Being diagnosed with gastroesophageal reflux disease (GERD)
- Age between 18 and 65 years
- Willingness to participate in the study assessments
Who cannot join
- Presence of a diagnosed psychiatric disorder
- Pregnancy or breastfeeding status
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of Symptom Severity, Posture, Musculoskeletal Pain, and Physical Activity Levels in Patients With Gastroesophageal Reflux Disease
This study is a cross-sectional research designed to investigate symptom severity, posture, musculoskeletal pain, and physical activity levels in individuals with gastroesophageal reflux disease (GERD).
Read the detailed description
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.
- Medical subject headings
- Gastroesophageal Reflux, Musculoskeletal Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
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.
Measured: 1 day
PROMIS GERD Scale
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.
Measured: 1 day
Postural Analysis
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.
Measured: 1 day
Visual Analog Scale (VAS)
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.
Measured: 1 day
International Physical Activity Questionnaire (IPAQ)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurcan Contarli, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643779
- Sponsor's protocol ID
- KBU-FTR-NC-09
- Status last verified
- May 2026
- First submitted
- 7 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Symptom Severity, Posture, Musculoskeletal Pain, and Physical Activity Levels in Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT07643779
- Acronym / sponsor ID
- KBU-FTR-NC-09
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a cross-sectional research designed to investigate symptom severity, posture, musculoskeletal pain, and physical activity levels in individuals with gastroesophageal reflux disease (GERD).
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without Gastroesophageal Reflux Disease
Key inclusion criteria (3 listed)
- Being diagnosed with gastroesophageal reflux disease (GERD)
- Age between 18 and 65 years
- Willingness to participate in the study assessments
Key exclusion criteria (2 listed)
- Presence of a diagnosed psychiatric disorder
- Pregnancy or breastfeeding status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gastroesophageal Reflux Disease Questionnaire (GERD-Q)
Time frame: 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.
PROMIS GERD Scale
Time frame: 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.
Postural Analysis
Time frame: 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.
Visual Analog Scale (VAS)
Time frame: 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.
International Physical Activity Questionnaire (IPAQ)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (GERD) and Symptom, run by Karabuk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurcan Contarli, PhD (+90 370 418 9171, nurcancontarli@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroesophageal Reflux Disease Questionnaire (GERD-Q) (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.