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

NCT05769985 | Unknown

• 1 other identifier: 03C213
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Pain intensity

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

  7 days

• Pain interference

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

  7 days

Interventions

Caregiver's responses and patient satisfaction OTHER

Interaction between caregivers' responses and patient satisfaction about those responses

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pain

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Auxologico Mosè Bianchi

Milan, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)