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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Web-assisted patient education intervention designed according to the common-sense model
The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.
Sponsored by
Meryem Otu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring Fibromyalgia, Web based intervention, Nursing, Illness perception

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Meryem Otu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Website Usability Scale
The scale consists of a total of 25 questions with four sub-dimensions (ease of navigation = 10 questions, design = 7 questions, ease of access = 4 questions, ease of use = 4 questions). The answers to the items of the scale are collected with a Likert-type five-point rating scale. The scale consists of "Strongly agree (5)", "Agree (4)", "Undecided (3)", "Disagree (2)" and "Strongly disagree (1)". 21 of the items in the scale are positive and 4 of them are negative items. The lowest score to be taken from the scale is 25 and the highest score is 125.

Full Information

First Posted
August 25, 2021
Last Updated
October 6, 2023
Sponsor
Meryem Otu
Collaborators
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05030558
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
September 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Meryem Otu
Collaborators
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Web based intervention, Nursing, Illness perception

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web-assisted patient education intervention designed according to the common-sense model
Intervention Description
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
Intervention Name(s)
The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.
Intervention Description
The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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).
Time Frame
Before application
Title
Visual Analog Scale
Description
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).
Time Frame
Immediately after application (1st mounth)
Title
Visual Analog Scale
Description
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).
Time Frame
1 month after application (2nd mounth)
Title
Illness Perception Scale
Description
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.
Time Frame
Before application
Title
Illness Perception Scale
Description
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.
Time Frame
Immediately after application (1st mounth)
Title
Illness Perception Scale
Description
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.
Time Frame
1 month after application (2nd mounth)
Title
Pain Coping Questionnaire
Description
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.
Time Frame
Before application
Title
Pain Coping Questionnaire
Description
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.
Time Frame
Immediately after application (1st mounth)
Title
Pain Coping Questionnaire
Description
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.
Time Frame
1 month after application (2nd mounth)
Title
Fibromyalgia Impact Questionnaire
Description
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.
Time Frame
Before application
Title
Fibromyalgia Impact Questionnaire
Description
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.
Time Frame
Immediately after application (1st mounth)
Title
Fibromyalgia Impact Questionnaire
Description
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.
Time Frame
1 month after application (2nd mounth)
Secondary Outcome Measure Information:
Title
Website Usability Scale
Description
The scale consists of a total of 25 questions with four sub-dimensions (ease of navigation = 10 questions, design = 7 questions, ease of access = 4 questions, ease of use = 4 questions). The answers to the items of the scale are collected with a Likert-type five-point rating scale. The scale consists of "Strongly agree (5)", "Agree (4)", "Undecided (3)", "Disagree (2)" and "Strongly disagree (1)". 21 of the items in the scale are positive and 4 of them are negative items. The lowest score to be taken from the scale is 25 and the highest score is 125.
Time Frame
Immediately after application (1st mounth)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şerife Karagözoğlu, Prof. Dr.
Organizational Affiliation
Cumhuriyet University
Official's Role
Study Director
Facility Information:
Facility Name
Meryem Otu
City
Sivas
ZIP/Postal Code
58140
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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