PainPainNCT06744634
Coping Strategies with Pain Among Older People
An observational study of Pain, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Chronic musculoskeletal pain is common among older adults. This study aimed to identify and describe the characteristics of chronic musculoskeletal pain, pain management and coping strategies among older adults from Turkey, Croatia and Romania. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Romania group, Turkey Group and Croatia Group
- How many people
- 336 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 30 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Geriatrics
Who may be able to join
- women and men aged between 65-85 years
- living in their own homes or in a nursing home
- older adults with chronic pain for at least 6 months,
- independent in activities of daily living, and independent in walking (with or without assistive walking devices).
Who cannot join
- Elderly adults with communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Analysis of Factors Associated with Chronic Musculoskeletal Pain, Pain Management Preferences, Coping Strategies and Health-related Quality of Life Among Older People: a Comparative Cross-Cultural Study of Turkey, Croatia and Romania
Chronic musculoskeletal pain is common among older adults. This study aimed to identify and describe the characteristics of chronic musculoskeletal pain, pain management and coping strategies among older adults from Turkey, Croatia and Romania. The study also aimed to explore cultural differences in pain experience and management.
Methods:
337 older adults with chronic pain participate 100 from Turkey, 131 from Croatia and 106 from Romania. Semi-structured interviews will explore four main topics, including factors influencing pain, coping strategies, management strategies, and health-related quality of life.
Read the detailed description
The questionnaire which was prepared by researchers will be performed by older adults. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire
- Conditions
- Pain
- Being tested
- Romania group, Turkey Group, Croatia Group
- Keywords
- Aged, Coping Strategy, Health-Related Quality of Life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romania groupOther
The questionnaire which was prepared by researchers will be performed by older adults from Romania. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire
Turkey GroupOther
The questionnaire which was prepared by researchers will be performed by older adults from Turkey The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire
Croatia GroupOther
The questionnaire which was prepared by researchers will be performed by older adults from Croatia. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Romania Group | The structured questionnaire was performed by older adults from Romania Receives: Other: Romania group | |
| Turkey Group | The structured questionnaire was performed by older adults from Turkey Receives: Other: Turkey Group | |
| Croatia Group | The structured questionnaire was performed by older adults from Croatia Receives: Other: Croatia Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A semi-structure questionnaire
Four main themes were
identified: (i) the factors affecting pain such as increasing and decreasing factors in ageing; (ii) the coping strategies with pain in ageing; (iii) the management strategies in ageing; (iv) the health related quality of life related pain in ageing
Measured: 1 week
Visuel analog scale
The VAS is a tool for measuring subjective experiences like pain, discomfort, or other sensations, commonly used with older adults in clinical settings. It helps assess pain intensity, especially in those with communication challenges due to cognitive decline or sensory impairment. VAS is useful for evaluating pain severity in conditions like osteoarthritis, neuropathy, post-surgical pain, and cancer-related pain In this study, participants will rate their pain on an 11-point scale, from 0 (no pain) to 10 (worst pain imaginable). Scores were categorized as severe (7-10), moderate (4-6,9), mild (1-3,9), or no pain (0)
Measured: 1 week
Secondary outcomes (1)
CDC Health related Quality of Life-4
develop to assess a person s sense of well-being through four questions. A core set of these measures (the CDC HRQOL-4) asks about self-rated general health and the number of recent days when a person is physically unhealthy, mentally unhealthy, or limited in usual activities.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start10 Dec 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 336 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylül Pınar KISA, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744634
- Sponsor's protocol ID
- Coping strategies
- Other IDs
- Biruni U
- Acronym
- Pain
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Factors Associated with Chronic Musculoskeletal Pain, Pain Management Preferences, Coping Strategies and Health-related Quality of Life Among Older People: a Comparative Cross-Cultural Study of Turkey, Croatia and Romania
- ClinicalTrials.gov ID
- NCT06744634
- Acronym / sponsor ID
- Pain / Coping strategies
- Conditions
- Pain
- Keywords
- Aged, Coping Strategy, Health-Related Quality of Life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Dec 2024 (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.
Chronic musculoskeletal pain is common among older adults. This study aimed to identify and describe the characteristics of chronic musculoskeletal pain, pain management and coping strategies among older adults from Turkey, Croatia and Romania. The study also aimed to explore cultural differences in pain experience and management.
Methods:
337 older adults with chronic pain participate 100 from Turkey, 131 from Croatia and 106 from Romania. Semi-structured interviews will explore four main topics, including factors influencing pain, coping strategies, management strategies, and health-related quality of life.
Detailed description
The questionnaire which was prepared by researchers will be performed by older adults. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Romania Group | – | Other: Romania groupThe structured questionnaire was performed by older adults from Romania |
| Turkey Group | – | Other: Turkey GroupThe structured questionnaire was performed by older adults from Turkey |
| Croatia Group | – | Other: Croatia GroupThe structured questionnaire was performed by older adults from Croatia |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Geriatrics
Key inclusion criteria (4 listed)
- women and men aged between 65-85 years
- living in their own homes or in a nursing home
- older adults with chronic pain for at least 6 months,
- independent in activities of daily living, and independent in walking (with or without assistive walking devices).
Key exclusion criteria (1 listed)
- Elderly adults with communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Romania groupThe questionnaire which was prepared by researchers will be performed by older adults from Romania. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire | Other | Romania Group |
| Turkey GroupThe questionnaire which was prepared by researchers will be performed by older adults from Turkey The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire | Other | Turkey Group |
| Croatia GroupThe questionnaire which was prepared by researchers will be performed by older adults from Croatia. The sociodemographic characteristics are recorded to part A section of questionnaire. The pain assessment section is part B and evaluate pain localization, intensity, type, factors affecting the pain, coping and management strategies of pain. Health related outcomes will be evaluated with CDC (Center of Disease Control and Prevention) Health related Quality of Life-4 Questionnaire | Other | Croatia Group |
Primary outcome
A semi-structure questionnaire
Time frame: 1 week
Four main themes were identified: (i) the factors affecting pain such as increasing and decreasing factors in ageing; (ii) the coping strategies with pain in ageing; (iii) the management strategies in ageing; (iv) the health related quality of life related pain in ageing
Visuel analog scale
Time frame: 1 week
The VAS is a tool for measuring subjective experiences like pain, discomfort, or other sensations, commonly used with older adults in clinical settings. It helps assess pain intensity, especially in those with communication challenges due to cognitive decline or sensory impairment. VAS is useful for evaluating pain severity in conditions like osteoarthritis, neuropathy, post-surgical pain, and cancer-related pain In this study, participants will rate their pain on an 11-point scale, from 0 (no pain) to 10 (worst pain imaginable). Scores were categorized as severe (7-10), moderate (4-6,9), mild (1-3,9), or no pain (0)
1 secondary outcome
CDC Health related Quality of Life-4
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Biruni 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
A semi-structure questionnaire (time frame: 1 week). The study lists 2 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 20 Dec 2024.