ClinicalTrials.gg
Status unknownNCT05769985CARE-MEUpdated Mar 15, 2023

Interaction Between Psychological States and Caregiver's Responses on Pain in Patients Suffering From Chronic Pain

An observational study in Chronic Pain, sponsored by Istituto Auxologico Italiano. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Istituto Auxologico Italiano · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
210
Ages
18 Years to 80 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.

This study's planned enrollment of 210 is above the median of 128 across 706 observational studies indexed under Chronic Pain.

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Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with chronic pain

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
210 participants (estimated)
Patient registry
No

Interventions

  • OtherCaregiver's responses and patient satisfaction

    Interaction between caregivers' responses and patient satisfaction about those responses

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What researchers measure

Primary outcomes

  1. Pain intensity

    Pain intensity as measured by a 0-10 Numeric Rating Scale

    Time frame: 7 days

  2. Pain interference

    Pain interference as measured by a 0-10 Numeric Rating Scale

    Time frame: 7 days

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Study locations

1 of 1 sites recruiting
  • Auxologico Mosè Bianchi
    Milan, 20149, Italy
    Recruiting
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References and documents

Individual participant data

Plan to share: Yes — The dataset will be uploaded to an online repository

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05769985
Responsible party
Sponsor
First posted
Mar 15, 2023
Start date
Jun 1, 2022
Primary completion
Jun 1, 2023 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Mar 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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