- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04543435
Investigation of Pain Coping Methods and Related Factors in Postmenopausal Women
Study Overview
Status
Conditions
Detailed Description
Musculoskeletal pain (MSP) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. If MSP lasts for longer than three months, it becomes chronic. The prevalence of chronic MSP (cMSP) increases with aging and its ratio changes between 35,7% and 49,8%. The previous studies demonstrated the differences in the prevalence of cMSP between men and women. According to most of the studies, older women adults are more vulnerable to experience than men due to some differences in perception of pain such as biological characteristics, their roles in daily life, beliefs or coping strategies with pain.
Oestrogen has a prominent role in the physiology of muscles, tendons, ligaments, and bones. The decline of this sex hormone during menopause transition could lead to MSP, particularly in the postmenopausal period. Indeed, an increasing rate of cMSP in postmenopausal women has been reported.
Coping strategies with pain are used to manage the pain and its impacts. Coping with pain requires the self-regulation of individuals using cognitive and behavioral reactions. Dealing with cMSP is a process that can need the making of changes in daily life and activities This study aimed to compare active and passive coping strategies being used and pain severity in postmenopausal women according to their age, marital status, educational status, and exercise habits. Also, subdomains of strategies and subdomains of pain and the relationship between pain and coping strategies in postmenopausal women with cMSP will be examined.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mersin, Turkey
- European University of Lefke
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- complaints of pain in anywhere of their body.
- presenting at least 1 year of amenorrhea
- being between the ages of 50-69 years.
Exclusion Criteria:
- have rheumatological, orthopedic and neurological diseases,
- have compression fractures, malignancies,
- have a chronic disease that will lead to secondary osteoporosis,
- have a drug use that will lead to secondary osteoporosis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
McGill Pain Questionnaire
Time Frame: 15 minutes
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This tool is used for assesment of pain, namely; body part of pain, timeframe, characteristic and severity of pain.
As score increases, pain condition worsens.
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15 minutes
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Pain Coping Inventory (PCI)
Time Frame: 10 minutes
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This tool is used for assessment of pain coping strategies.
The higher score received means that coping strategy is used more.
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10 minutes
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Timed up and go test
Time Frame: 5 minutes
|
This tool is used for assessment of functional mobility.
The duration to complete the task (in seconds) is used as a score.
As the score increase, the functional mobility decrease.
|
5 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Beliz B Kaygısız, PT, PhD, European University of Lefke
- Study Director: Nuray ELİBOL, Ege University
- Study Chair: Sevim Acaröz Candan, T.C. ORDU ÜNİVERSİTESİ
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ÜEK/47/01/12/1920/05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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