- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05039372
Rheumatoid Arthritis, Planned Behavıor Theory And Nurse Counselıng
The Effect Of Nurse Counselıng Applıed Accordıng To Planned Behavıor Theory On Paın, Fatıgue And Functıonal Status In Patıents Wıth Rheumatoid Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Examining the studies in the literature, the effect size between the experimental group and the control group was calculated and it was estimated to be around 0.70. In the experimental and control groups, a total of 68 individuals, including at least 34 individuals in both groups, should be included in the study in order to determine the difference between the groups in the power analysis calculated with 80% power and 0.05 significance. Considering that there would be individuals who could not continue to work or could not be reached afterwards, the number of required to be reached individuals was calculated as 74 individuals. In this study, the sample size was calculated with the GPower program version 3.1.
Type and Time of Research
This research is planned to be conducted as a randomized controlled experimental study.
Application of Research
In the research, the applications to be made to the control and experimental groups are explained separately:
*Control Group Intervention: After obtaining written consent from the patients who agreed to participate in the study, the patients included in the control group were asked to continue their rheumatologist follow-up and their normal lives (hospital routine, daily life). Patients in this group will fill out the "Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Evaluation Questionnaire" at the first interview. After 3 months, data collection tools other than the "Patient Identification Form" will be applied to the patients and the training guide to be prepared for Rheumatoid Arthritis patients will be given.
Experimental Group Initiative: After obtaining written consent from the patients who agreed to participate in the study, they will be asked to continue with their rheumatologist follow-up and their normal lives (hospital routine, daily life).
"Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered to the patients in this group at the first interview. Individual training will be given to the patient in line with the training guide prepared for the rheumatoid arthritis patient, and the guide will be shared after the training. Mutual contact information will be shared with the patient and it will be stated that he can call during the counseling period (3 months).In line with the theory of planned behavior in patients with Rheumatoid Arthritis counseling service will be provided by the researcher to the extent of the training plan prepared for symptom management. At the end of the 3rd month, the patients will be interviewed face to face and the "Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered again.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey, 27000
- Hasan Kalyoncu Uninersity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Criteria:
Inclusion Criteria for Research
- Between 18 and 64 years old
- Diagnosed with Rheumatoid Arthritis at least 6 months ago,
- Can communicate in Turkish and does not have a cognitive problem that prevents communication,
- No neurological or psychiatric disease without malignancy,
- Without heart failure (stages III and IV according to NYHA)
- Not pregnant,
- Able to use a telephone,
- Patients who volunteer to participate in the study will be included in the study.
Exclusion Criteria
- Under 18 years old,
- Newly diagnosed, treated for less than 6 months,
- Having a malignant type of disease,
- Patients who do not volunteer to participate in the study will not be included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: training and consultancy
"Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered to the patients in this group at the first interview.
Individual training will be given to the patient in line with the training guide prepared for the rheumatoid arthritis patient, and the guide will be shared after the training.
In line with the theory of planned behavior in patients with rheumatoid arthritis, counseling service will be provided by the researcher to the extent of the training plan prepared for symptom management.
At the end of the 3rd month, the patients will be interviewed face to face and the "Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Assessment Questionnaire" will be administered again.
|
TRAINING AND CONSULTANCY
|
No Intervention: control
After obtaining written consent from the patients who agreed to participate in the study, the patients included in the control group were asked to continue their rheumatologist follow-up and their normal lives (hospital routine, daily life).
Patients in this group will fill out the "Patient Description Form, Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire, McGill Pain Scale Short Form, Stanford Health Evaluation Questionnaire" at the first interview.
After 3 months, data collection tools other than the "Patient Identification Form" will be applied to the patients and the training guide to be prepared for rheumatoid arthritis patients will be given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Patient-Reported Fatigue
Time Frame: 0-3 months
|
Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ): It was developed to evaluate the effect of fatigue in different dimensions in patients with rheumatoid arthritis.
There are 20 questions in total.
Total BRAF-MDQ scores range from 0 to 70.
Higher scores indicate higher fatigue.
|
0-3 months
|
Evaluation of Patient-Reported Pain
Time Frame: 0-3 months
|
McGill Pain Scale Short Form (MAS-SF): The scale provides information about the sensory characteristics, severity and effect of pain.
The main component of the scale consists of 15 descriptive adjectives for sensation of pain and is self-rated by the patient according to the level of intensity on a scoring scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
|
0-3 months
|
Assessment of Patient-Reported Functional Status
Time Frame: 0-3 months
|
Stanford Health Assessment Scale (HAQ): The Health Assessment Scale is a functional measurement method that is frequently used to evaluate the functional status of rheumatology patients in their daily lives.
The scale consists of 20 items in the form of 8 sections.
A high score on the scale indicates functional disability.
|
0-3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nermin Olgun, professor, Hasan Kalyoncu University Faculty of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- interventional (Oncolys BioPharma Inc)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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