Web-supported Interactive Nurse Program in Fibromyalgia Patients: A Mixed Method Study

NCT ID: NCT05030558

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-09-05

Brief Summary

This study was planned to examine the effect of the web-supported interactive nurse program developed in line with the Common-Sense Model on the perception of illness, coping with pain and severity of illness in fibromyalgia patients. Mixed method is a research. The exploratory sequential design, one of the mixed research methods, will be used. The research will continue with the quantitative part starting with the qualitative part. The quantitative part of the research is a randomized controlled experimental study.

Detailed Description

Fibromyalgia is a very common musculoskeletal disease characterized by increased pain sensitivity. Hospital admissions are increasing with symptoms such as fibromyalgia, chronic pain, fatigue, sleep disturbance, depression and cognitive problems, and this is reflected in general health care expenditures. The absence of objective markers to diagnose the disease, the social recognition of fibromyalgia, and the negative perception of the disease by patients in its clinical management creates a permanent problem. Individuals who perceive fibromyalgia as having more severe cognitive consequences and less controllable are more affected by the symptoms of the disease. Therefore, understanding the patient's perceptions of the disease is important for effective health management and reducing the severity of the disease and improving the patient's health outcomes. Although there are many descriptive studies showing that fibromyalgia patients have a negative perception of illness, no study has been found in which the effectiveness of the education offered with the self-regulation model for the perception of illness was evaluated in fibromyalgia patients.

Aim: This research was planned to examine the effect of the Web-Assisted Interactive Nursing Program designed according to the Common-Sense Model on the perception of illness, coping with pain and severity of illness in fibromyalgia patients.

Method: The study was designed as an exploratory mixed method research in which qualitative and quantitative research methods were used together. The qualitative and quantitative research sample will consist of patients diagnosed with fibromyalgia according to the American College of Rheumatology (ACR) 2010 Criteria by the physician. "Criteria sampling method", one of the purposive sampling methods used in qualitative research, will be used to determine the individuals to be included in the qualitative part of the research. Qualitative interviews will be conducted face to face. Interviews with people will continue until data saturation is reached. In the qualitative part of the research, individual in-depth interview method will be selected and "Semi-Structured Interview Form" will be used as a data collection tool. Interviews with people will continue until data saturation is reached. All interviews will be recorded in digital format, transcribed and then transferred to the qualitative analysis software MAXQDA. In line with the data obtained in the qualitative dimension of the research, the design of the web-supported interactive nursing program will be created.

The quantitative part of the study will be carried out as a randomized controlled trial using the block randomization method. Randomization will be done by a statistician other than the researcher. Power analysis was calculated using G * Power 3.1.9.7 program. With 0.95 effect size, 95% power and 0.05 significance level, the required sample size was determined as 30 individuals per group, and 60 individuals in total. It was decided to include 70 individuals, 35 individuals in the intervention group and 31 individuals in the control group, by taking 15% more of the calculated sample against the possibility of sample loss during the study. In the quantitative part of the research, the web-supported interactive nurse program will last 1 month and the application will last for 2 months. A text message will be sent to their phone to remind individuals to use the website. Messages will be sent twice a week, for a total of 8 times. Visual Analogue Scale (VAS), Website Usability Scale, Illness Perception Scale (IPQ), Pain Coping Scale (PCI), Fibromyalgia Impact Questionnaire (FIQ) will be used as measurement tools. Data collection forms will be applied to the intervention and control groups three times in total, before the start of the WeB-supported interactive nurse program, at the end of the Web-supported interactive nurse program (1st month) and at the 2nd month. The data obtained after each evaluation will be transferred to the "Statistical Package for Social Sciences Software" (SPSS).

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Interventional group

The web-supported interactive nursing program intervention will last 4 weeks. In the first week of the training, the identity and causes of the disease, which is one of the sub-dimensions of the perception of illness, will be emphasized, and the themes of misperception determined in this field through qualitative study will be emphasized. In the second week, they will be asked to look at training sessions that discuss perceptions of the illness's timeline and consequences. In the last two weeks of the training, they will be asked to attend the trainings for the control of Fibromyalgia symptoms. During the study, short mobile phone messages containing reminders and motivations will be sent regularly twice a week (8 times). Data collection forms will be applied to the intervention group 3 times before starting the web-based interactive nurse program, at the end of the program (in the 1st month) and then at the end of the 2nd month.

Group Type: EXPERIMENTAL

Web-assisted patient education intervention designed according to the common-sense model

Intervention Type: BEHAVIORAL

Implementation of patient education with the website created about fibromyalgia disease in 4 weeks according to the disease perception themes reached as a result of the qualitative research.

Control Group

The Fibromyalgia patient booklet of the Turkish Physical Medicine and Rehabilitation Association will be available in pdf format on the website of the participants assigned to the control group. Participants in this group will be able to access other trainings after the end of the study, if they wish.

Data collection forms will be applied to the control group 3 times in total, before the start of the study, in the 1st month and the 2nd month of the study.

Group Type: ACTIVE_COMPARATOR

The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.

Intervention Type: BEHAVIORAL

The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.

Interventions

Web-assisted patient education intervention designed according to the common-sense model

Implementation of patient education with the website created about fibromyalgia disease in 4 weeks according to the disease perception themes reached as a result of the qualitative research.

Intervention Type: BEHAVIORAL

The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.

The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with a mean score of 4 or greater on the Visual Analogue Scale (VAS)
• Patients whose drug treatment was stable and no non-pharmacological intervention was applied during the study period,
• Patients with basic computer literacy,
• Patients with computer access.

Exclusion Criteria

• Individuals with secondary inflammatory rheumatic disease or another diagnosed disease that may contribute to chronic pain
• Patients with hearing, vision and understanding problems,
• Patients whose drug therapy was changed or who received any non-pharmacological therapy during the study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: collaborator

Meryem Otu

OTHER

Sponsor Role: lead

Responsible Party

Meryem Otu

Nurse

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Şerife Karagözoğlu, Prof. Dr.

Role: STUDY_DIRECTOR

Cumhuriyet University

Locations

Meryem Otu

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Sivas Cumhuriyet University

Identifier Type: -

Identifier Source: org_study_id