- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04789590
Multidimensional Geriatric Pain Assessment
March 4, 2021 updated by: AKİF BULUT, Uludag University
Determining the Effectiveness of the Geriatric Pain Measure ın Older Adults Attending a Gynecology Clinic
This descriptive study was conducted on 100 patients who applied to the gynecology outpatient clinic to determine the effectiveness of the Geriatric Pain Measure (GPM) in elderly individuals.
The data of the study were collected using the Patient Information Form, the GPM, and the Standardized Mini Mental State Examination (SMMSE).
The mean GPM score of the elderly individuals, who had an average age of 70 (65-90), was found to be 27.37 (0-88), the sub-dimension mean scores were 9.52 (0-49.9),
7.14 (0-14.2),
4.76 (0-9.5),
2.38 (0-11.9),
and 4.76 (0-11.9)
respectively.
It was determined that 54% of the patients had mild pain (0-29), 38% of them had moderate pain (30-69), and 8% of them had severe pain (70 and above).
The findings of the present study were similar to the results of numerous other studies in which both the same scale and different scales were used to assess pain in elderly individuals.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bursa, Turkey, 16000
- Bursa Province Public Hospitals Union General Secretariat Health Sciences University Bursa High Specialization Education and Research Hospital
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female patients 65 years of age or older who applied to gynecology clinic.
Description
Inclusion Criteria:
- 65 years and older patients,
- Scoring 23 or above in the Standardized Mini Mental State Examination,
- Have no obstacle to answering questions,
- Not addicted to alcohol or other substances,
- No trauma in the last six months.
Exclusion Criteria:
- Patients younger than 65,
- Scoring less than 23 points in the Standardized Mini Mental State Examination,
- Who have a situation that prevents them from answering questions,
- Are addicted to alcohol or other substances,
- Trauma in the last six months.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determining the pain levels of patients aged 65 and over
Time Frame: 4 months
|
The Geriatric Pain Measure is a 24-item multidimensional scale developed by Ferrell et al. (2000), for elderly individuals treated on an outpatient basis.
Its validity and reliability in Turkish were confirmed by Dursun and Bektaş (2017).
The Turkish version of the scale has five sub-dimensions: withdrawal due to pain (Factor 1; Items 19, 20, 22, 23); pain intensity (Factor 2; Items 1, 2, 3, 4, 5, 6); pain with movement (Factor 3; Items 9, 10, 11, 12); pain with strenuous activities (Factor 4; Items 7, 8, 18, 21, 24); and pain with other activities (Factor 5; Items 13, 14, 15, 16, 17).
The total score is calculated by adding the "Yes" answers, and each item is multiplied by 2.38 and the total is converted into a score of between 0 and 100.
Scores between 0 and 29 are considered to indicate mild pain, scores between 30 and 69 are considered to indicate moderate pain, and scores of 70 and above are considered to indicate severe pain.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the Intensive Care Unit: executive summary. Am J Health Syst Pharm. 2013 Jan 1;70(1):53-8. doi: 10.1093/ajhp/70.1.53.
- Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
- Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.
- Blozik E, Stuck AE, Niemann S, Ferrell BA, Harari D, von Renteln-Kruse W, Gillmann G, Beck JC, Clough-Gorr KM. Geriatric Pain Measure short form: development and initial evaluation. J Am Geriatr Soc. 2007 Dec;55(12):2045-50. doi: 10.1111/j.1532-5415.2007.01474.x. Epub 2007 Nov 20.
- Cavlak U, Yagci N, Bas Aslan U, Ekici G. A new tool measuring health-related quality of life (HRQOL): the effects of musculoskeletal pain in a group of older Turkish people. Arch Gerontol Geriatr. 2009 Sep-Oct;49(2):298-303. doi: 10.1016/j.archger.2008.11.002. Epub 2008 Dec 19.
- Hairi NN, Cumming RG, Blyth FM, Naganathan V. Chronic pain, impact of pain and pain severity with physical disability in older people--is there a gender difference? Maturitas. 2013 Jan;74(1):68-73. doi: 10.1016/j.maturitas.2012.10.001. Epub 2012 Oct 25.
- Jackson T, Thomas S, Stabile V, Han X, Shotwell M, McQueen K. Prevalence of chronic pain in low-income and middle-income countries: a systematic review and meta-analysis. Lancet. 2015 Apr 27;385 Suppl 2:S10. doi: 10.1016/S0140-6736(15)60805-4. Epub 2015 Apr 26.
- Zwakhalen SM, Hamers JP, Abu-Saad HH, Berger MP. Pain in elderly people with severe dementia: a systematic review of behavioural pain assessment tools. BMC Geriatr. 2006 Jan 27;6:3. doi: 10.1186/1471-2318-6-3.
- Larsson C, Hansson EE, Sundquist K, Jakobsson U. Chronic pain in older adults: prevalence, incidence, and risk factors. Scand J Rheumatol. 2017 Jul;46(4):317-325. doi: 10.1080/03009742.2016.1218543. Epub 2016 Nov 25.
- Layman Young J, Horton FM, Davidhizar R. Nursing attitudes and beliefs in pain assessment and management. J Adv Nurs. 2006 Feb;53(4):412-21. doi: 10.1111/j.1365-2648.2006.03735.x.
- Sirsch E, Lukas A, Drebenstedt C, Gnass I, Laekeman M, Kopke K, Fischer T; Guideline workgroup (Schmerzassessment bei alteren Menschen in der vollstationaren Altenhilfe, AWMF Registry 145-001). Pain Assessment for Older Persons in Nursing Home Care: An Evidence-Based Practice Guideline. J Am Med Dir Assoc. 2020 Feb;21(2):149-163. doi: 10.1016/j.jamda.2019.08.002. Epub 2019 Oct 24.
- Clough-Gorr KM, Blozik E, Gillmann G, Beck JC, Ferrell BA, Anders J, Harari D, Stuck AE. The self-administered 24-item geriatric pain measure (GPM-24-SA): psychometric properties in three European populations of community-dwelling older adults. Pain Med. 2008 Sep;9(6):695-709. doi: 10.1111/j.1526-4637.2008.00497.x.
- Cornally N, McCarthy G. Chronic pain: the help-seeking behavior, attitudes, and beliefs of older adults living in the community. Pain Manag Nurs. 2011 Dec;12(4):206-17. doi: 10.1016/j.pmn.2010.12.006. Epub 2011 Feb 26.
- Damico V, Murano L, Cazzaniga F, Dal Molin A. Pain prevalence, severity, assessment and management in hospitalized adult patients: a result of a multicenter cross sectional study. Ann Ist Super Sanita. 2018 Jul-Sep;54(3):194-200. doi: 10.4415/ANN_18_03_05.
- Dursun G, Bektas H. Cultural Validation and Reliability of the Turkish Version of the Geriatric Pain Measure in the Elderly. Pain Pract. 2017 Apr;17(4):505-513. doi: 10.1111/papr.12473. Epub 2016 Jul 2.
- Ferrell BA, Stein WM, Beck JC. The Geriatric Pain Measure: validity, reliability and factor analysis. J Am Geriatr Soc. 2000 Dec;48(12):1669-73. doi: 10.1111/j.1532-5415.2000.tb03881.x.
- Horgas AL, Elliott AF, Marsiske M. Pain assessment in persons with dementia: relationship between self-report and behavioral observation. J Am Geriatr Soc. 2009 Jan;57(1):126-32. doi: 10.1111/j.1532-5415.2008.02071.x. Epub 2008 Nov 18.
- Husebo BS, Strand LI, Moe-Nilssen R, Borgehusebo S, Aarsland D, Ljunggren AE. Who suffers most? Dementia and pain in nursing home patients: a cross-sectional study. J Am Med Dir Assoc. 2008 Jul;9(6):427-33. doi: 10.1016/j.jamda.2008.03.001. Epub 2008 Jun 2.
- Iliffe S, Kharicha K, Carmaciu C, Harari D, Swift C, Gillman G, Stuck AE. The relationship between pain intensity and severity and depression in older people: exploratory study. BMC Fam Pract. 2009 Jul 28;10:54. doi: 10.1186/1471-2296-10-54.
- Leong IY, Farrell MJ, Helme RD, Gibson SJ. The relationship between medical comorbidity and self-rated pain, mood disturbance, and function in older people with chronic pain. J Gerontol A Biol Sci Med Sci. 2007 May;62(5):550-5. doi: 10.1093/gerona/62.5.550.
- Liberman O, Freud T, Peleg R, Keren A, Press Y. Chronic pain and geriatric syndromes in community-dwelling patients aged >/=65 years. J Pain Res. 2018 Jun 19;11:1171-1180. doi: 10.2147/JPR.S160847. eCollection 2018.
- Motter FR, Hilmer SN, Paniz VMV. Pain and Inflammation Management in Older Adults: A Brazilian Consensus of Potentially Inappropriate Medication and Their Alternative Therapies. Front Pharmacol. 2019 Dec 2;10:1408. doi: 10.3389/fphar.2019.01408. eCollection 2019.
- Nawai A, Leveille SG, Shmerling RH, van der Leeuw G, Bean JF. Pain severity and pharmacologic pain management among community-living older adults: the MOBILIZE Boston study. Aging Clin Exp Res. 2017 Dec;29(6):1139-1147. doi: 10.1007/s40520-016-0700-9. Epub 2017 Feb 21.
- Park J, Cho B, Paek Y, Kwon H, Yoo S. Development of a pain assessment tool for the older adults in Korea: the validity and reliability of a Korean version of the geriatric pain measure (GPM-K). Arch Gerontol Geriatr. 2009 Sep-Oct;49(2):199-203. doi: 10.1016/j.archger.2008.07.010. Epub 2008 Sep 10.
- Reynolds KS, Hanson LC, DeVellis RF, Henderson M, Steinhauser KE. Disparities in pain management between cognitively intact and cognitively impaired nursing home residents. J Pain Symptom Manage. 2008 Apr;35(4):388-96. doi: 10.1016/j.jpainsymman.2008.01.001. Epub 2008 Feb 15.
- van Herk R, van Dijk M, Baar FP, Tibboel D, de Wit R. Observation scales for pain assessment in older adults with cognitive impairments or communication difficulties. Nurs Res. 2007 Jan-Feb;56(1):34-43. doi: 10.1097/00006199-200701000-00005.
- Ware LJ, Epps CD, Herr K, Packard A. Evaluation of the Revised Faces Pain Scale, Verbal Descriptor Scale, Numeric Rating Scale, and Iowa Pain Thermometer in older minority adults. Pain Manag Nurs. 2006 Sep;7(3):117-25. doi: 10.1016/j.pmn.2006.06.005.
- Woo J, Leung J, Lau E. Prevalence and correlates of musculoskeletal pain in Chinese elderly and the impact on 4-year physical function and quality of life. Public Health. 2009 Aug;123(8):549-56. doi: 10.1016/j.puhe.2009.07.006. Epub 2009 Aug 25.
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)
August 1, 2018
Primary Completion (Actual)
November 1, 2019
Study Completion (Actual)
November 1, 2019
Study Registration Dates
First Submitted
March 2, 2021
First Submitted That Met QC Criteria
March 4, 2021
First Posted (Actual)
March 9, 2021
Study Record Updates
Last Update Posted (Actual)
March 9, 2021
Last Update Submitted That Met QC Criteria
March 4, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ABULUT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
In the work permit obtained from Bursa Provincial Health Directorate, it was stipulated that the study data should not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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