Family Nursing Conversations Patients With Chronic Non-Cancer Pain

NCT03981302 | Completed DMC

• 1 other identifier: Family nursing chronic pain
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic Nonmalignant Pain; Family Nursing; Multidisciplinary Pain Center; Quasi-Experimental Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ)

  Assesed at week 9

• Quality of life, QoL (SF12)

  Assesed at week 9

• The Hospital Anxiety and depression Scale (HADS)

  Assesed at week 9

Study Arms (2)

Family nursing conversations

EXPERIMENTAL

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.

Other: Family nursing conversations

Usual treatment

NO INTERVENTION

The patients will receive usual treatment.

Interventions

Family nursing conversations OTHER

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.

Family nursing conversations

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bente Appel Esbensen: lead
• Rigshospitalet, Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Multidisciplinary Pain Centre, Department of Neuroanaesthesiology, The Neuroscience Centre, Rigshospitalet, University of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Publications (10)

• 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.

  PMID: 21194394 BACKGROUND

• 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.

  PMID: 25844555 BACKGROUND

• Bell JM. Family Systems Nursing: re-examined. J Fam Nurs. 2009 May;15(2):123-9. doi: 10.1177/1074840709335533. No abstract available.

  PMID: 19423766 BACKGROUND

• 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.

  PMID: 25995203 BACKGROUND

• 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.

  PMID: 25026964 BACKGROUND

• Chesla CA. Do family interventions improve health? J Fam Nurs. 2010 Nov;16(4):355-77. doi: 10.1177/1074840710383145.

  PMID: 21051754 BACKGROUND

• 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.

  PMID: 26645546 BACKGROUND

• 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.

  PMID: 14512253 BACKGROUND

• 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.

  PMID: 24123548 BACKGROUND

• 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.

  PMID: 22834990 BACKGROUND

Study Officials

• Bente A Esbensen, Ass Prof

  Rigshospitalet, Centre for rheumatology and spine diseases, copecare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager and Associate Professor

Model Details: The study has a quasi-experimental design and will conduct baseline and post-test in two comparable groups of patients and their selected family members: An intervention group and a historical control group. The data from the historical control group will be collected initially in the study to prevent pollution of the data when the intervention nurses are educated in Family nursing. The study is a part of a superior explanatory sequential mixed methods design consisting of a total of three substudies. The two other substudies have qualitative designs.

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: June 10, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)