Family Nursing Conversations Patients With Chronic Non-Cancer Pain

NCT03981302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2024-02-28

No results posted yet for this study

Summary

This study assumes that family nursing will enhance the management of chronic nonmalignant pain (CNP) for the patients and their family members. CNP accounts for a major healthcare problem with a thorough impact on several levels. Living with CNP is a condition of life, that calls for acceptance, but due to the invisible nature of CNP, the patients often experience a lack of understanding and doubt about the condition´s reality making acceptance challenging. Research indicates that the involvement of relatives has a positive effect on the management of CNP. An existential need for individualised adapted involvement is expressed by patients and relatives. Family nursing has the potential to comply with the expressed need but is not investigated on patients with CNP.

The objective of the study is to explore if an intervention with systematic family nursing conversations with patients with chronic nonmalignant pain and their selected family members is effective on primary self-efficacy and secondary family function, quality of life and anxiety/depression. The intervention is based on the concept of "family systems nursing" developed by Wright and Leahey. Besides usual treatment, the intervention consists of 3-4 structured conversations each 1,5 hour between the nurse, the patient and their selected family members. Previous to the intervention, the involved nurses will go through a family nursing course of three days duration. During the intervention, regular reflection sessions will be conducted.

The study design is quasi-experimental with a baseline- and a post-test in two comparable groups of patients and their selected family members: An intervention group and a control group. The design is chosen to prevent contamination of the control group data if the nurses change behaviour regarding families after participating in the course. Collection of data from the control group will be completed before the course. In the intervention group, a follow-up assessment will be conducted four months after the post-test. Structured telephone interviews will obtain the selected self-reported outcomes from patients and their family members.

The study will follow the ethical guidelines of the Declaration of Helsinki (World-Medical-Association, 2008). The Data Protection Agency has approved the study with j-number VD-2019-152. According to The Danish National Committee on Health Research Ethics, there is no obligation to notify the study (record number: H-19016896).

Conditions

  • Chronic Nonmalignant Pain

Interventions

OTHER

Family nursing conversations

The intervention is based on the concept "family systems nursing" developed by Wright \& Maureen. Family nursing aims to change restricting beliefs and alleviate illness suffering. The Illness Beliefs model and Calgarymodels are essential components. The illness beliefs model illuminates the family's different beliefs about their problems. The Calgary models consist of the Calgary family assessment model and the Calgary intervention model and aim to support change and help the family to find new ways to handle the illness. The use of the components cannot be standardised but must be tailored to match the needs of the specific family. The family nursing conversations in this intervention will last 1,5 hour. Every family will be offered three family nursing conversations with roughly three weeks interval. If the family after three conversations express a need for follow-up, they will be offered the fourth conversation.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER
  • University of Copenhagen

    collaborator OTHER
  • Bente Appel Esbensen

    lead OTHER

Principal Investigators

  • Bente A Esbensen, Ass Prof · Rigshospitalet, Centre for rheumatology and spine diseases, copecare

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03981302 on ClinicalTrials.gov