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

NCT05030558 | Completed

• 1 other identifier: Sivas Cumhuriyet University
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Web based intervention; Nursing; Illness perception

Outcome Measures

Primary Outcomes (12)

• Visual Analog Scale

  VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).

  Before application

• Visual Analog Scale

  VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).

  Immediately after application (1st mounth)

• Visual Analog Scale

  VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).

  1 month after application (2nd mounth)

• Illness Perception Scale

  The scale consists of 70 items and three sub-dimensions: * Type of disease, * Opinions about the disease, * Dimensions of disease causes. Disease Type Dimension: It consists of 14 items. It is answered with yes or no. The sum of yes answers gives the score for this sub-dimension. Opinions on the Disease Dimension: This sub-dimension consists of 38 items. Responses to each item are evaluated with a five-point Likert-type measurement ranging from "1: I definitely don't think" to "5: I definitely think". Causes of Disease Dimension: It consists of 18 items that investigate the patient's thoughts about the possible causes of the disease. A five-point Likert type measurement is used. The score of the entire scale is found by summing the scores obtained from these sub-dimensions.

  Before application

• Illness Perception Scale

  The scale consists of 70 items and three sub-dimensions: * Type of disease, * Opinions about the disease, * Dimensions of disease causes. Disease Type Dimension: It consists of 14 items. It is answered with yes or no. The sum of yes answers gives the score for this sub-dimension. Opinions on the Disease Dimension: This sub-dimension consists of 38 items. Responses to each item are evaluated with a five-point Likert-type measurement ranging from "1: I definitely don't think" to "5: I definitely think". Causes of Disease Dimension: It consists of 18 items that investigate the patient's thoughts about the possible causes of the disease. A five-point Likert type measurement is used. The score of the entire scale is found by summing the scores obtained from these sub-dimensions.

  Immediately after application (1st mounth)

• Illness Perception Scale

  The scale consists of 70 items and three sub-dimensions: * Type of disease, * Opinions about the disease, * Dimensions of disease causes. Disease Type Dimension: It consists of 14 items. It is answered with yes or no. The sum of yes answers gives the score for this sub-dimension. Opinions on the Disease Dimension: This sub-dimension consists of 38 items. Responses to each item are evaluated with a five-point Likert-type measurement ranging from "1: I definitely don't think" to "5: I definitely think". Causes of Disease Dimension: It consists of 18 items that investigate the patient's thoughts about the possible causes of the disease. A five-point Likert type measurement is used. The score of the entire scale is found by summing the scores obtained from these sub-dimensions.

  1 month after application (2nd mounth)

• Pain Coping Questionnaire

  The scale evaluates chronic pain patients' ways of coping with organic or psychogenic pain. The 29-item self-report scale is answered on a 4-point Likert scale (0 = never, 3 = often). Scores range from 0 to 3 for each item. The total score for each subtest is calculated by summing the scores obtained from the items in that subtest.

  Before application

• Pain Coping Questionnaire

  The scale evaluates chronic pain patients' ways of coping with organic or psychogenic pain. The 29-item self-report scale is answered on a 4-point Likert scale (0 = never, 3 = often). Scores range from 0 to 3 for each item. The total score for each subtest is calculated by summing the scores obtained from the items in that subtest.

  Immediately after application (1st mounth)

• Pain Coping Questionnaire

  The scale evaluates chronic pain patients' ways of coping with organic or psychogenic pain. The 29-item self-report scale is answered on a 4-point Likert scale (0 = never, 3 = often). Scores range from 0 to 3 for each item. The total score for each subtest is calculated by summing the scores obtained from the items in that subtest.

  1 month after application (2nd mounth)

• Fibromyalgia Impact Questionnaire

  The scale measures 10 different characteristics: physical function, well-being, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Higher scores indicate that the disease affects the person more. The total score can be between 0-80. A score of 80 indicates high influence.

  Before application

• Fibromyalgia Impact Questionnaire

  The scale measures 10 different characteristics: physical function, well-being, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Higher scores indicate that the disease affects the person more. The total score can be between 0-80. A score of 80 indicates high influence.

  Immediately after application (1st mounth)

• Fibromyalgia Impact Questionnaire

  The scale measures 10 different characteristics: physical function, well-being, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. Higher scores indicate that the disease affects the person more. The total score can be between 0-80. A score of 80 indicates high influence.

  1 month after application (2nd mounth)

Secondary Outcomes (1)

• Website Usability Scale

  Immediately after application (1st mounth)

Study Arms (2)

Interventional group

EXPERIMENTAL

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.

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

Control Group

ACTIVE COMPARATOR

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.

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 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.

Interventional group

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

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

Control Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meryem Otu: lead
• Cumhuriyet University: collaborator

Study Sites (1)

Meryem Otu

Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Growth Differentiation Factor 15

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Growth Differentiation Factors; TGF-beta Superfamily Proteins; Proteins; Biological Factors

Study Officials

• Şerife Karagözoğlu, Prof. Dr.

  Cumhuriyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients participating in the study will know that they are in a randomized controlled study, but they will not know which group they are in until the study is completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 1, 2021
• Study Start: September 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: September 5, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)