FibromyalgiaNCT05030558
Web-supported Interactive Nurse Program in Fibromyalgia Patients: A Mixed Method Study
A study testing Web-assisted patient education intervention designed according to the common-sense model and The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf. in people with Fibromyalgia, run by Meryem Otu at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Web-assisted patient education intervention designed according to the common-sense model and The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 5 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Web Supported Interactive Nursing Program on Illness Perception, Pain Management and Disease Intensity in Fibromyalgia: A Mixed Method Study
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.
Read the 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
- Being tested
- 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.
- Keywords
- Fibromyalgia, Web based intervention, Nursing, Illness perception
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-assisted patient education intervention designed according to the common-sense modelBehavioural
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.
The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.Behavioural
The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month after application (2nd mounth)
Secondary outcomes (1)
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.
Measured: Immediately after application (1st mounth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Sep 2021
- Primary completion30 Dec 2022
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meryem Otu
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University
- Responsible party
- Sponsor-investigator, Meryem Otu, Cumhuriyet University
- Investigators
- Şerife Karagözoğlu, Prof. Dr., Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030558
- Sponsor's protocol ID
- Sivas Cumhuriyet University
- Status last verified
- Oct 2023
- First submitted
- 25 Aug 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Web Supported Interactive Nursing Program on Illness Perception, Pain Management and Disease Intensity in Fibromyalgia: A Mixed Method Study
- ClinicalTrials.gov ID
- NCT05030558
- Acronym / sponsor ID
- Sivas Cumhuriyet University
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Web based intervention, Nursing, Illness perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Meryem OtuUniversity, hospital or other
- Collaborators
- Cumhuriyet University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: Web-assisted patient education intervention designed according to the common-sense modelThe 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. |
| Control Group | Active comparator | Behavioral: The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-assisted patient education intervention designed according to the common-sense modelImplementation 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. | Behavioural | Interventional group |
| 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. | Behavioural | Control Group |
Primary outcome
Visual Analog Scale
Time frame: Before application
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
Time frame: Immediately after application (1st mounth)
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
Time frame: 1 month after application (2nd mounth)
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
Time frame: Before application
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
Time frame: Immediately after application (1st mounth)
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
Time frame: 1 month after application (2nd mounth)
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
Time frame: Before application
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
Time frame: Immediately after application (1st mounth)
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
Time frame: 1 month after application (2nd mounth)
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
Time frame: Before application
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
Time frame: Immediately after application (1st mounth)
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
Time frame: 1 month after application (2nd mounth)
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 secondary outcome
Website Usability Scale
Time frame: Immediately after application (1st mounth)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şerife Karagözoğlu, Prof. Dr. study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-assisted patient education intervention designed according to the common-sense model and The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf. in people with Fibromyalgia, run by Meryem Otu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Before application). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.