Clinical trial · Interventional
Family Nursing Conversations Patients With Chronic Non-Cancer Pain
Family Nursing Conversations With Patients With Chronic Non-cancer Pain and Their Selected Family Members. Protocol for the FANCOC-PAIN Quasi-experimental Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Nonmalignant Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Family nursing conversations | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Family nursing conversations
- description
- 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.
- interventionNames
- Other: Family nursing conversations
- type
- NO_INTERVENTION
- label
- Usual treatment
- description
- The patients will receive usual treatment.
Primary outcomes (1)
- measure
- The general self-efficacy scale (GSE)
- timeFrame
- Assesed at week 9
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDReid 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. PMID 21194394
- BACKGROUNDTreede 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. PMID 25844555
- BACKGROUNDBell JM. Family Systems Nursing: re-examined. J Fam Nurs. 2009 May;15(2):123-9. doi: 10.1177/1074840709335533. No abstract available. PMID 19423766
- BACKGROUNDBell 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. PMID 25995203
- BACKGROUNDOstlund 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. PMID 25026964
- BACKGROUNDChesla CA. Do family interventions improve health? J Fam Nurs. 2010 Nov;16(4):355-77. doi: 10.1177/1074840710383145. PMID 21051754
- BACKGROUNDMorales-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.