PainNCT04543435
Investigation of Pain Coping Methods and Related Factors in Postmenopausal Women
An observational study of Pain, run by European University of Lefke at 1 site in Turkey (Türkiye).
Trial summary
Musculoskeletal pain (MSP) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. Coping strategies with pain are used to manage the pain and its impacts. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women only
- Conditions the study is for
- Pain
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Sep 2020to 15 Nov 2020
- 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 50 to 69 years
- Women only
- Adult, Older adult
Study population: Patients presented to a rehabilitation clinic with complaints of pain in anywhere of their body and who are volunteer for the study will be included. Informed consent will be signed by the participants.
Who may be able to join
- complaints of pain in anywhere of their body.
- presenting at least 1 year of amenorrhea
- being between the ages of 50-69 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Musculoskeletal pain (MSP) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. Coping strategies with pain are used to manage the pain and its impacts. The present study aimed to compare active and passive coping strategies used and pain severity in postmenopausal women according to their demographic characteristics. Also, the relationship between pain and coping strategies in postmenopausal women with cMSP will be examined.
Read the 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.
- Conditions
- Pain
- Keywords
- postmenopausal, pain coping
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Pain Questionnaire
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.
Measured: 15 minutes
Pain Coping Inventory (PCI)
This tool is used for assessment of pain coping strategies. The higher score received means that coping strategy is used more.
Measured: 10 minutes
Timed up and go test
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start17 Sep 2020
- Primary completion30 Oct 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Lefke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beliz B Kaygısız, PT, PhD, Principal investigator, European University of LefkeNuray Elibol, Study director, Ege UniversitySevim Acaröz Candan, Study chair, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543435
- Sponsor's protocol ID
- ÜEK/47/01/12/1920/05
- Status last verified
- Jan 2021
- First submitted
- 2 Sep 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pain Coping Methods and Related Factors in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04543435
- Acronym / sponsor ID
- ÜEK/47/01/12/1920/05
- Conditions
- Pain
- Keywords
- postmenopausal, pain coping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- European University of LefkeUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 10 Sep 2020 (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.
Musculoskeletal pain (MSP) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. Coping strategies with pain are used to manage the pain and its impacts. The present study aimed to compare active and passive coping strategies used and pain severity in postmenopausal women according to their demographic characteristics. Also, the relationship between pain and coping strategies in postmenopausal women with cMSP will be examined.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients presented to a rehabilitation clinic with complaints of pain in anywhere of their body and who are volunteer for the study will be included. Informed consent will be signed by the participants.
Key inclusion criteria (3 listed)
- complaints of pain in anywhere of their body.
- presenting at least 1 year of amenorrhea
- being between the ages of 50-69 years.
Key exclusion criteria (4 listed)
- 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
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
McGill Pain Questionnaire
Time frame: 15 minutes
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.
Pain Coping Inventory (PCI)
Time frame: 10 minutes
This tool is used for assessment of pain coping strategies. The higher score received means that coping strategy is used more.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Beliz B Kaygısız, PT, PhD principal investigator
European University of Lefke
Nuray Elibol study director
Ege University
Sevim Acaröz Candan study chair
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by European University of Lefke 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 3 inclusion and 4 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 8 Jan 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?
McGill Pain Questionnaire (time frame: 15 minutes). The study lists 3 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 8 Jan 2021.