Family Nursing Conversations With Patients With Chronic Non-cancer Pain and Their Selected Family Members. Protocol for the FANCOC-PAIN Quasi-experimental Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- The general self-efficacy scale (GSE)
研究概览
简要总结
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).
详细描述
Introduction
This study assumes that family nursing for the patients with Chronic nonmalignant pain (CNP) and their family members by increased self-efficacy will enhance the management of the changed life condition and alleviate the related suffering of the family. The study has a quasi-experimental design and is the first sub-study of a superior mixed methods study consisting of a total of three sub-studies. The other substudies apply qualitative designs.
Background
CNP is usually understood as pain with a duration of at least three months with no relation to life-threatening causes. CNP accounts for a major healthcare problem with a thorough impact on several levels. Nineteen per cent of the adult European population has been found to suffer from moderate to severe CNP, which decreases physical and mental health, ability to work, wellbeing and quality of life. Additional mortality is increased. CNP has consequences for the patients´ social network as well and is associated with a poorer family function. The relatives get affected themselves with reduced physical and mental health. Living with CNP is a condition of life, that calls for acceptance. But CNP is an invisible illness, and despite the considerable impact, the patients often experience a lack of understanding and doubt about, whether the CNP is real. In the strive to achieve a legitim sick role and help to alleviate the suffering, patients with CNP continually seek out the health care system. The expenses at the socioeconomic level are compared to other chronic diseases comprehensive. Thus, gaining acceptance of CNP may be challenging.
Involvement of relatives for patients with CNP is sparsely described in the literature, but indicates, that involvement increases marital satisfaction and contribute to a better outcome for both patients and spouses. Managing CNP necessitates "being on the same page", and involvement of relatives is vital to obtain a common understanding. Within other disease areas, the involvement of relatives has resulted in reduced stress for spouses, closer family relations and increased family function. Thus, it may be assumed that the involvement of relatives has a positive effect on the management of CNP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who start a trajectory at the Multidisciplinary Paincentre at Rigshospitalet.
- •Every patient selects a maximum of three family member at the age of 15 years or older, whom the patient from a comprehensive understanding perceive as a family
排除标准
- •Patients or family members, who already receive family therapy with each other.
- •Patients or family members, who are cognitively impaired.
- •Patients or family members or dont speak or understand Danish.
研究组 & 干预措施
Family nursing conversations
The intervention will consist of structured family nursing conversations between a nurse, the patient and their selected family members. The patients will receive the intervention and usual treatment.
干预措施: Family nursing conversations (Other)
Usual treatment
The patients will receive usual treatment.
结局指标
主要结局
The general self-efficacy scale (GSE)
时间窗: Assesed at week 9
General self-efficacy refers to global confidence in one´s coping ability across a wide range of demanding or novel situations. GSE is tested in 25 countries, including Denmark, and GSE is suggested to be a universal construct. GSE consists of ten items with every four categories of answers varying from "not at all true" to "exactly true". Thus the score can range from 10 to 40. The higher the score, the higher the general self-efficacy. The average GSE is 29,716, but there is no cut-off score.
次要结局
- The Hospital Anxiety and depression Scale (HADS)(Assesed at week 9)
- Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ)(Assesed at week 9)
- Quality of life, QoL (SF12)(Assesed at week 9)
研究者
Bente Appel Esbensen
Research Manager and Associate Professor
Glostrup University Hospital, Copenhagen