An interventional study of Training group in Hemodialysis Patient and Hemodialysis Catheter, sponsored by Kafkas University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Kafkas University · Not applicable, Interventional, and Prevention
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This study will be conducted to evaluate the effect of Arterio-Venous Fistula (AVF) care training given to hamodialysis patients on quality of life, comfort and self-care behaviours. Patient education is one of the practices that help patients to gain self-care behaviours as well as reducing the cost of health expenditures. Nurses are health professionals who play an important role in patient education. Nurses provide patient education by using different materials. These materials can sometimes be mobile phones, videos, web-based applications, sometimes face-to-face interviews with patients, brochures or written materials. In this study, a training programme for AVF care will be developed. In addition, it is expected that the AVF care training to be given to HD patients will increase the quality of life and comfort areas, and increase the awareness and well-being levels of patients in self-care behaviours. The effectiveness of the study will be expanded by presenting the results of the research as a paper in an international comprehensive congress. An article of the study will be published in a journal scanned in international indexes and will be included in the literature.
This study will be conducted to determine the effect of Arterio-Venous Fistula (AVF) care training given to haemodialysis patients on quality of life, comfort and self-care behaviours.
The research will be conducted as an experimental, pre-test post-test randomised controlled experimental study.
Hypotheses:
H0: AVF care training given to haemodialysis patients has no effect on patients' quality of life, comfort and self-care behaviours.
H1: AVF care training given to haemodialysis patients affects patients' quality of life.
H2: AVF care training given to haemodialysis patients affects patients' comfort.
H3: AVF care training given to haemodialysis patients affects patients' self-care behaviours.
The research population will consist of a total of 67 patients receiving HD treatment in the Dialysis Unit and having AVF. Similar study data were taken into consideration in the selection of the research sample. As a result of the power analysis performed in the G*Power version 3.1.9.7 programme, it was determined that a total of 52 participants, at least one person for each of the intervention and control groups, should be included in the sample size, 95% confidence interval, 95% test power (1-ß), 0.05% margin of error level.
Randomisation and Blinding Simple random sampling method will be used for randomisation of the study. In order to avoid interactions between the patients participating in the study, they will be grouped according to the days of HD treatment sessions. In Group I: Patients receiving HD treatment on Mondays, Wednesdays and Fridays, and in Group II; patients receiving HD treatment on Tuesdays, Thursdays and Saturdays. Which group will be the control group and which will be the intervention group will be decided by drawing lots.
Inclusion Criteria for the Study:
Exclusion Criteria for the Study:
Data Collection / Intervention Procedure First, patients will be informed about the study and will be asked to sign an informed consent form. Then, all participants will fill out the questionnaire forms as a pre-test application.
No training will be given to the patients in the control group and the questionnaire forms will be applied again after 8 weeks. The patients in the intervention group will be given 8 weeks of AVF care training. At the end of the training, the questionnaire forms will be applied to the patients again and the effectiveness of the training will be evaluated.
Training Booklet Content The training booklet will be prepared using literature reviews, research results, and evidence-based practice guides. After the training booklet is created, it will be sent for expert opinion. The training booklet will include topics on fluid control, diet, and medication management.
Training Program Goals
248 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
This study's planned enrollment of 60 is close to the median of 64 across 166 interventional studies indexed under Arteriovenous Fistula.
Browse Arteriovenous Fistula studies →Kafkas University is the lead sponsor of 32 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Not consenting to participate in the study
HD patients who fulfil the inclusion criteria will be met face-to-face. Patients who agree to participate in the study will be asked to sign an informed consent form. Afterwards, Patient Information Form, SF-12 Quality of Life Short Form, Comfort Scale for Hemodialysis Patients and Scale for Evaluation of Self-Care Behaviours Regarding Arteriovenous Fistula in Hemodialysis Patients will be given to the patients and those who can read and write will be asked to fill them in by themselves. For illiterate patients, pre-test data will be collected by reading the questionnaire forms by the investigators. No treatment will be applied to the participants in this group. At the end of 8 weeks, all participants will be asked to fill in the Patient Information Form, SF-12 Quality of Life Short Form, Comfort Scale for Hemodialysis Patients and Self-Care Behaviour Assessment Scale for Arteriovenous Fistula in Hemodialysis Patients as a post-test application.
Other: Training group
Patients in the intervention group will receive AVF care training. The training will last for 8 weeks and is planned to be given once a week. In the first session, the patients in the intervention group will be introduced. Afterwards, general information will be provided about the purpose and applications of AVF training and the importance of participation in training will be emphasized. Afterwards, patients who agree to participate in the study will sign an informed consent form. In addition, the Patient Information Form, SF-12 Quality of Life Short Form, the Comfort Scale for Hemodialysis Patients and the Scale for Assessing Self-Care Behaviors Related to Arteriovenous Fistula in Hemodialysis Patients will be given and asked to answer. For those who cannot read or write, the researchers will read the survey forms. In the first session, the pre-test data of the patients will be collected and then the training books will be given.
Evaluation of Self-Care Behaviours Regarding Arteriovenous Fistula in Hemodialysis Patients
The scale was developed by Sousa et al. to evaluate patients' care behaviors related to arteriovenous fistula and to follow up patients' education. The scale was developed in Portuguese and its validity and reliability for the Turkish society was performed by İkiz and Usta. It is a 16-item, 5-point Likert scale consisting of single-sentence phrases. The scale consists of two sub-dimensions as symptom and "Symptom Management" and "Prevention of Complications". The item numbers of the Symptom and Symptom Management sub-dimension of the scale are 1,3,6,11,13,16 and the item numbers of the Complication Prevention sub-dimension are 2,4,5,7,8,9,10,12,14,15.22. The time required to administer the scale is about 2-3 minutes. While 16 indicates the lowest possible score in the scoring of the scale, 80 indicates the highest score. The lowest possible score from the symptom and symptom management sub-dimension is 6 and the highest score is 30. The lowest score that can be obtained from the sub-d
Time frame: eight weeks
Comfort Scale for Haemodialysis Patients (HCP)
It was revised by Orak et al. (2017) by using the General Comfort Scale developed by Kolcaba (1992) and later comfort scales developed specifically for certain situations. The scale consists of 9 items and 2 sub-dimensions (overcoming and relaxing). The responses given to the 4th item of the 5-point Likert-type scale are scored as "never" 1 point, "very rarely" 2 points, "sometimes" 3 points, "very often" 4 points and "always" 5 points. The scores given to the other items (1-3, 5-9) are scored in reverse: "never" 5 points, "very rarely" 4 points, "sometimes" 3 points, "very often" 2 points and "always" 1 point. The evaluation of the scale is determined by calculating the average score, the lowest score that can be obtained from the scale is 1, the highest score is 5. The comfort level increases as the score gets closer to 5. The scale has two sub-dimensions: "Relaxation" (items 7-9) and "Overcoming" (items 1-6).
Time frame: eight weeks
SF-12 Quality of Life Short Form
SF-12 was developed by Ware et al. (1996). The Turkish version of the scale was developed by Soylu and Kütük. The scale is an outcome measure filled out by the patient, evaluating the impact of health on the individual's daily life. SF-12 is basically a shortened version of SF36, consisting of 8 sub-dimensions and a total of 12 items. This scale evaluates physical functioning with 2 items, physical role with 2 items, body pain with 1 item, general health with 1 item, energy with 1 item, social functioning with 1 item, emotional role with 2 items, and mental health with 2 items.
Time frame: eight weeks
No study locations are listed for this record.
Plan to share: No
Start is estimated for Sep 2025; primary completion for Dec 2025, 3 months later.
Of 58 non-industry interventional studies with no phase under Arteriovenous Fistula, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 43. This study's planned 3 months is below that.
Counting every sponsor, half of 84 studies reached it within 22 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Kafkas University