AzTrials
AzTrials

PainNCT04789590

Multidimensional Geriatric Pain Assessment

An observational study of Pain, run by Uludag University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Pain
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2018to 1 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

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 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Study population: Female patients 65 years of age or older who applied to gynecology clinic.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bursa Province Public Hospitals Union General Secretariat Health Sciences University Bursa High Specialization Education and Research Hospital

    Bursa, 16000

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Conditions
Pain
Keywords
Geriatric Pain Measure, Pain Assessment, Elderly Adults
Medical subject headings
Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determining the pain levels of patients aged 65 and over

    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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start1 Aug 2018
  3. Primary completion1 Nov 2019
  4. Study completion1 Nov 2019

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04789590
Sponsor's protocol ID
ABULUT
Status last verified
Mar 2021
First submitted
2 Mar 2021
Last updated
9 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In the work permit obtained from Bursa Provincial Health Directorate, it was stipulated that the study data should not be shared.

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.

    PubMed 23261901

  • 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.

    PubMed 18031489

  • 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.

    PubMed 19101046

  • 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.

    PubMed 30212442

  • 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.

    PubMed 12794644

  • 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.

    PubMed 23103063

  • 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.

    PubMed 26313056

  • 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.

    PubMed 16441889

  • 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.

    PubMed 27885914

  • 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.

    PubMed 16448484

  • 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.

    PubMed 31668640

  • 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.

    PubMed 18816330

  • 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.

    PubMed 22117752

  • 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.

    PubMed 30284545

  • 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.

    PubMed 27370573

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, run by Uludag University at 1 site in Turkey (Türkiye).

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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determining the pain levels of patients aged 65 and over (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04789590, which also lists 28 linked publications.

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 9 Mar 2021.

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