Clinical trial NCT05030558: Web-supported Interactive Nurse Program in Fibromyalgia Patients: A Mixed Method Study
Official title: Effect of Web Supported Interactive Nursing Program on Illness Perception, Pain Management and Disease Intensity in Fibromyalgia: A Mixed Method Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Web based intervention
Nursing
Illness perception
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
Collaborators: name: Cumhuriyet University
First posted: 2021-09-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Before application
measure: Visual Analog Scale
timeFrame: Immediately after application (1st mounth)
measure: Visual Analog Scale
timeFrame: 1 month after application (2nd mounth)
measure: Illness Perception Scale
timeFrame: Before application
measure: Illness Perception Scale
timeFrame: Immediately after application (1st mounth)
measure: Illness Perception Scale
timeFrame: 1 month after application (2nd mounth)
measure: Pain Coping Questionnaire
timeFrame: Before application
measure: Pain Coping Questionnaire
timeFrame: Immediately after application (1st mounth)
measure: Pain Coping Questionnaire
timeFrame: 1 month after application (2nd mounth)
measure: Fibromyalgia Impact Questionnaire
timeFrame: Before application
measure: Fibromyalgia Impact Questionnaire
timeFrame: Immediately after application (1st mounth)
measure: Fibromyalgia Impact Questionnaire
timeFrame: 1 month after application (2nd mounth)
Secondary outcomes:
measure: Website Usability Scale
timeFrame: Immediately after application (1st mounth)
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Meryem Otu
Study officials:
affiliation: Cumhuriyet University
name: Şerife Karagözoğlu, Prof. Dr.
role: STUDY_DIRECTOR
References: