Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05030558
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2021-08-25
Brief Title:
Web-supported Interactive Nurse Program in Fibromyalgia Patients A Mixed Method Study
Sponsor:
Meryem Otu
Organization:
Cumhuriyet University
Study Overview
Official Title:
Effect of Web Supported Interactive Nursing Program on Illness Perception Pain Management and Disease Intensity in Fibromyalgia A Mixed Method Study
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients perceptions of the disease is important for effective health management and reducing the severity of the disease and improving the patients 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 3197 program With 095 effect size 95 power and 005 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
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 3197 program With 095 effect size 95 power and 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None