- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06877481
Turkish Validation of the Geriatric Pain Measure - Short Form
March 18, 2025 updated by: Tuba Tanyel Saraçoğlu, Başakşehir Çam & Sakura City Hospital
Turkish Adaptation, Validation, and Reliability Assessment of the Geriatric Pain Measure - Short Form
This study aims to adapt, validate, and assess the reliability of the Geriatric Pain Measure - Short Form in Turkish.
A total of 150 patients aged 65 years and older will complete the scale under the supervision of pain management and gerontology specialists.
Reliability and validity will be evaluated using statistical analyses, including internal consistency, test-retest reliability, and correlation with validated pain and sleep scales.
Ethical approval has been obtained, and all participants will provide informed consent.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
For the Turkish adaptation, validation, and reliability study of the Geriatric Pain Measure - Short Form, permission was obtained from Dr. Eva Blozik, the original developer of the scale.
The adaptation process will follow standard cross-cultural validation guidelines, including forward translation into Turkish by an expert group, back-translation into English by a separate expert group, and comparison of the back-translated version with the original English version for conceptual and linguistic accuracy.
A multidisciplinary expert panel, including Turkish language specialists and pain management experts, will review the final Turkish version, making necessary cultural adaptations to ensure semantic equivalence.
The study will involve 150 patients aged 65 years and older visiting the Pain Management Clinic, where they will complete the Turkish version of the scale under the supervision of pain management and gerontology specialists.
Reliability will be assessed through internal consistency (Cronbach's alpha), test-retest reliability, and item-total correlations, while construct validity will be evaluated using factor analysis.
Concurrent validity will be examined by correlating the Turkish version of the scale with other outcome measures.
Ethical approval has been obtained from Başakşehir Çam and Sakura City Hospital Ethics Committee, and all participants will provide written informed consent before participation.
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tuba Tanyel Saraçoğlu, Medical Doctor
- Phone Number: 30721 00902129096000
- Email: tuba.saracoglu1@saglik.gov.tr
Study Locations
-
-
Başakşehir
-
İstanbul, Başakşehir, Turkey
- Recruiting
- Başakşehir Çam and Sakura City Hospital
-
Contact:
- Tuba Tanyel Saraçoğlu, Medical Doctor
- Phone Number: +0902129096000
- Email: tuba.saracoglu1@saglik.gov.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients over 65 years of age who applied to the pain management outpatient clinic with the complaint of chronic pain and consented to participate the study.
Description
Inclusion Criteria:
- Geriatric patients with chronic pain
- Patients who agreed to participate in the study
Exclusion Criteria:
- Demantia
- Mental of physical disorders that effect patients answering the scales
- Diagnosis of malignancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Geriatric Patients with Chronic Pain
Geriatric patients (≥65 years) with chronic pain who are examined at the Pain Management Clinic of Başakşehir Çam and Sakura City Hospital.
Participants will be assessed under the supervision of pain management and gerontology specialists.
|
Geriatric Pain Measure - Short Form (GPM-SF) is a validated pain assessment tool designed specifically for older adults.
It is a 12-item questionnaire that evaluates pain intensity, interference with daily activities, and emotional impact of chronic pain in geriatric patients.
The short form provides a quick and reliable assessment of pain-related disability in older populations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geriatric Pain Measurement Short Form
Time Frame: Day 1
|
Geriatric Pain Measure - Short Form (GPM-SF) is a validated pain assessment tool designed specifically for older adults.
It is a 12-item questionnaire that evaluates pain intensity, interference with daily activities, and emotional impact of chronic pain in geriatric patients.
The short form provides a quick and reliable assessment of pain-related disability in older populations.
|
Day 1
|
|
Numerik Rating Scale
Time Frame: Day 1
|
The Numeric Rating Scale (NRS) is a 0 to 10 scale used to assess pain intensity, where 0 = no pain and 10 = worst possible pain.
It is a simple, reliable tool widely used in clinical and research settings.
|
Day 1
|
|
FRAIL Scale
Time Frame: Day 1
|
The FRAIL Scale is a five-item questionnaire used to assess frailty in older adults.
It evaluates Fatigue, Resistance (weakness), Ambulation (mobility), Illnesses (comorbidities), and Loss of weight.
A higher score indicates a greater degree of frailty, helping identify patients at risk for adverse health outcomes.
|
Day 1
|
|
Lawton & Brody Instrumental Activities of Daily Living Scale
Time Frame: Day 1
|
The Lawton & Brody Instrumental Activities of Daily Living, a scale that assesses an older adult's ability to perform eight complex daily tasks essential for independent living.
These tasks include using the telephone, shopping, meal preparation, housekeeping, laundry, transportation, medication management, and handling finances.
It helps evaluate functional independence and detect early declines in cognitive or physical abilities
|
Day 1
|
|
Geriatric Depression Scale-15
Time Frame: Day 1
|
The Geriatric Depression Scale-15 (GDS-15) is a shortened version of the original GDS, consisting of 15 yes/no questions designed to screen for depression in older adults.
It is simple, quick, and reliable, making it suitable for use in clinical and research settings, including in patients with mild cognitive impairment.
Higher scores indicate more depressive symptoms.
|
Day 1
|
|
Pittsburgh Sleep Quality Index
Time Frame: Day 1
|
The Pittsburgh Sleep Quality Index is a self-reported questionnaire assessing sleep quality over the past month.
It includes 18 items evaluating aspects such as sleep duration, latency, disturbances, efficiency, daytime dysfunction, and use of sleep medications.
A higher total score indicates poorer sleep quality
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2025
Primary Completion (Estimated)
May 15, 2025
Study Completion (Estimated)
June 15, 2025
Study Registration Dates
First Submitted
March 10, 2025
First Submitted That Met QC Criteria
March 10, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 18, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26.02.2025.73
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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