Chronic Nonmalignant Pain Clinical Trial
— FANCOC-PAINOfficial title:
Family Nursing Conversations With Patients With Chronic Non-cancer Pain and Their Selected Family Members. Protocol for the FANCOC-PAIN Quasi-experimental Trial
Verified date | February 2024 |
Source | Glostrup University Hospital, Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 143 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Multidisciplinary Pain Centre, Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Bente Appel Esbensen | Rigshospitalet, Denmark, University of Copenhagen |
Denmark,
Bell JM, Wright LM. The Illness Beliefs Model: advancing practice knowledge about illness beliefs, family healing, and family interventions. J Fam Nurs. 2015 May;21(2):179-85. doi: 10.1177/1074840715586889. No abstract available. — View Citation
Bell JM. Family Systems Nursing: re-examined. J Fam Nurs. 2009 May;15(2):123-9. doi: 10.1177/1074840709335533. No abstract available. — View Citation
Chesla CA. Do family interventions improve health? J Fam Nurs. 2010 Nov;16(4):355-77. doi: 10.1177/1074840710383145. — View Citation
Glenton C. Chronic back pain sufferers--striving for the sick role. Soc Sci Med. 2003 Dec;57(11):2243-52. doi: 10.1016/s0277-9536(03)00130-8. — View Citation
Morales-Espinoza EM, Kostov B, Salami DC, Perez ZH, Rosalen AP, Molina JO, Gonzalez-de Paz L, Momblona JMS, Areu JB, Brito-Zeron P, Ramos-Casals M, Siso-Almirall A; CPSGPC Study Group. Complexity, comorbidity, and health care costs associated with chronic widespread pain in primary care. Pain. 2016 Apr;157(4):818-826. doi: 10.1097/j.pain.0000000000000440. — View Citation
Ostlund U, Persson C. Examining Family Responses to Family Systems Nursing Interventions: An Integrative Review. J Fam Nurs. 2014 Aug;20(3):259-286. doi: 10.1177/1074840714542962. Epub 2014 Jul 15. — View Citation
Reid KJ, Harker J, Bala MM, Truyers C, Kellen E, Bekkering GE, Kleijnen J. Epidemiology of chronic non-cancer pain in Europe: narrative review of prevalence, pain treatments and pain impact. Curr Med Res Opin. 2011 Feb;27(2):449-62. doi: 10.1185/03007995.2010.545813. Epub 2011 Jan 3. — View Citation
Swift CM, Reed K, Hocking C. A new perspective on family involvement in chronic pain management programmes. Musculoskeletal Care. 2014 Mar;12(1):47-55. doi: 10.1002/msc.1059. Epub 2013 Oct 7. — View Citation
Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available. — View Citation
West C, Usher K, Foster K, Stewart L. Chronic pain and the family: the experience of the partners of people living with chronic pain. J Clin Nurs. 2012 Dec;21(23-24):3352-60. doi: 10.1111/j.1365-2702.2012.04215.x. Epub 2012 Jul 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The general self-efficacy scale (GSE) | 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. | Assesed at week 9 | |
Secondary | Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ) | ICE-EFFQ is developed by the conceptual framework of Calgary Family Assessment Model for families, who experience acute or chronic illness. ICE-EFFQ measure family function within the last four weeks and consists of 17 items within four categories: Expressing emotions, collaboration and problem-solving, communication and behaviour. It uses a Likert scale with a scoring range from 1 (almost never) to 5 (all the time). The score can vary between 17 and 85. A high score indicates a good family function, but no exact cut-off score distinguishes between optimal or less optimal family function. | Assesed at week 9 | |
Secondary | Quality of life, QoL (SF12) | SF-12 is the short form of a generic international quality of life instrument with 12 items, often used to asses health results and health-related quality of life. SF-12 measures self-reported health-related physical and mental quality of life. The SF12 provides data within the two main categories: Physical and mental health, each divided into four health domains. The total raw scores in each health domain are transformed into 0-100 scores, again transformed into T-scores. A higher score indicates a better health state. | Assesed at week 9 | |
Secondary | The Hospital Anxiety and depression Scale (HADS) | HADS is developed to measure anxiety and depression in general medical outpatient clinics and takes into account that psychological and biological symptoms by medical diseases are hardly distinguishable. HADS consists of two subscales for respectively anxiety and depression with every seven items and measures self-reported symptoms the last seven days. The items are rated on a four-point scale and scored from 0-3 with total scores in each subscale ranging from 0-21. Scores between 0-7 represent no case, scores between 8-10 indicates mild cases, scores between 11-15 indicates moderate cases, and scores from 16 and above suggests severe cases. | Assesed at week 9 |
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