Chronic PainCARE-MENCT05769985
Interaction Between Psychological States and Caregiver's Responses on Pain in Patients Suffering From Chronic Pain
An observational study of Chronic Pain, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Chronic pain is a major cause of disability, and given its negative impact on the functional, psychological, and social well-being of sufferers, it is crucial to identify the biopsychosocial factors that influence it. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Caregiver's responses and patient satisfaction
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 1 Jun 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic pain
Who may be able to join
- Medical diagnosis of condition associated with chronic pain
- Presence of a caregiver associated by kinship and living together for at least six months
- Having given written consent at the time of treatment received at one of the OUs involved in the project to the possibility of being contacted to participate in research for scientific purposes.
Who cannot join
- Patients diagnosed with psychosis, dementia, or psychiatric comorbidities
- Patients who, at the time of recruitment, will be hospitalized or who will be undergoing inpatient rehabilitation treatment or who will have a scheduled surgery to be performed during the study period
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Auxologico Mosè Bianchi
Milan, 20149
Emanuele Giusti, PhD, 3498798942, e.giusti@auxologico.it
About this study
Official title: Study on the Interaction Between Psychological States and Caregiver's Responses on Pain in Patients Suffering From Chronic Pain
Chronic pain is a major cause of disability, and given its negative impact on the functional, psychological, and social well-being of sufferers, it is crucial to identify the biopsychosocial factors that influence it. While biological and psychological factors have been extensively studied, the role of the patient's relational context has not been thoroughly investigated to date. The presence of pain affects both directly and indirectly the patient's family and social context, which could significantly influence the perception of pain itself. In particular, partners of chronic pain patients may experience high levels of stress, anxiety, and worry, and this may have an impact on couple satisfaction and the type of partner's responses with respect to the patient's pain manifestations. It is conceivable that the type of interaction between patient and partner is influenced by the intersection of the ways in which the patient expresses pain, such as by manifesting catastrophic experiences, with the type of responses provided by the partner, such as of criticism, distraction, or support. It can be hypothesized that both the partner's actual responses to the patient's manifestations of pain and the patient's satisfaction with these responses are important. This study therefore aims to understand the relationships between these factors. Specifically, it will assess whether attributions and catastrophizing behaviors of the patient influence pain intensity and interference over time through mediation by the responses given by the partner. It will also be assessed whether this mediation is moderated by the patient's satisfaction with the partner's responses.
- Conditions
- Chronic Pain
- Being tested
- Caregiver's responses and patient satisfaction
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver's responses and patient satisfactionOther
Interaction between caregivers' responses and patient satisfaction about those responses
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity as measured by a 0-10 Numeric Rating Scale
Measured: 7 days
Pain interference
Pain interference as measured by a 0-10 Numeric Rating Scale
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769985
- Sponsor's protocol ID
- 03C213
- Acronym
- CARE-ME
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will be uploaded to an online repository
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Interaction Between Psychological States and Caregiver's Responses on Pain in Patients Suffering From Chronic Pain
- ClinicalTrials.gov ID
- NCT05769985
- Acronym / sponsor ID
- CARE-ME / 03C213
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 15 Mar 2023 (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 pain is a major cause of disability, and given its negative impact on the functional, psychological, and social well-being of sufferers, it is crucial to identify the biopsychosocial factors that influence it. While biological and psychological factors have been extensively studied, the role of the patient's relational context has not been thoroughly investigated to date. The presence of pain affects both directly and indirectly the patient's family and social context, which could significantly influence the perception of pain itself. In particular, partners of chronic pain patients may experience high levels of stress, anxiety, and worry, and this may have an impact on couple satisfaction and the type of partner's responses with respect to the patient's pain manifestations. It is conceivable that the type of interaction between patient and partner is influenced by the intersection of the ways in which the patient expresses pain, such as by manifesting catastrophic experiences, with the type of responses provided by the partner, such as of criticism, distraction, or support. It can be hypothesized that both the partner's actual responses to the patient's manifestations of pain and the patient's satisfaction with these responses are important. This study therefore aims to understand the relationships between these factors. Specifically, it will assess whether attributions and catastrophizing behaviors of the patient influence pain intensity and interference over time through mediation by the responses given by the partner. It will also be assessed whether this mediation is moderated by the patient's satisfaction with the partner's responses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic pain
Key inclusion criteria (3 listed)
- Medical diagnosis of condition associated with chronic pain
- Presence of a caregiver associated by kinship and living together for at least six months
- Having given written consent at the time of treatment received at one of the OUs involved in the project to the possibility of being contacted to participate in research for scientific purposes.
Key exclusion criteria (2 listed)
- Patients diagnosed with psychosis, dementia, or psychiatric comorbidities
- Patients who, at the time of recruitment, will be hospitalized or who will be undergoing inpatient rehabilitation treatment or who will have a scheduled surgery to be performed during the study period
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 |
|---|---|---|
| Caregiver's responses and patient satisfactionInteraction between caregivers' responses and patient satisfaction about those responses | Other | – |
Primary outcome
Pain intensity
Time frame: 7 days
Pain intensity as measured by a 0-10 Numeric Rating Scale
Pain interference
Time frame: 7 days
Pain interference as measured by a 0-10 Numeric Rating Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Yes. The dataset will be uploaded to an online repository
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
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 Chronic Pain, run by Istituto Auxologico Italiano at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 7 days). 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 15 Mar 2023.