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

NCT ID: NCT05769985

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-06-01

Brief 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.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Caregiver's responses and patient satisfaction

Interaction between caregivers' responses and patient satisfaction about those responses

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Auxologico Mosè Bianchi

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Emanuele Giusti, PhD

Role: primary

e.giusti@auxologico.it

3498798942

Other Identifiers

03C213

Identifier Type: -

Identifier Source: org_study_id