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

Chronic Pain Clinical Trial

— CARE-ME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769985
• Other study ID #: 03C213
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Caregiver's responses and patient satisfaction
Interaction between caregivers' responses and patient satisfaction about those responses

Locations

Country	Name	City	State
Italy	Auxologico Mosè Bianchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity as measured by a 0-10 Numeric Rating Scale	7 days
Primary	Pain interference	Pain interference as measured by a 0-10 Numeric Rating Scale	7 days