Nurse's RoleNCT06534476
Effectiveness of Education Given to Patients With Hemodialysis Patients
A study testing Education in people with Nurse's Role, run by Zeynep Yildirim at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effects of education given to patients receiving hemodialysis treatment on self-care agency and fluid control. This study has a pre-test-post-test quasi-experimental design. A total of 54 hemodialysis patients who met the inclusion criteria were included in the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Apr 2023to 12 Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years old and above
- Receiving dialysis treatment for at least three months
- Being literate
Who cannot join
- Having communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Hemodialysis Patients on Patients' Self-Care Ability and Fluid Control
This study was conducted to investigate the effects of education given to patients receiving hemodialysis treatment on self-care agency and fluid control. This study has a pre-test-post-test quasi-experimental design. A total of 54 hemodialysis patients who met the inclusion criteria were included in the study.
Read the detailed description
Chronic diseases are one of the major public health problems. Chronic renal failure (CKD) is among the chronic diseases that cause death worldwide. CKD is defined as a chronic and progressive deterioration in the kidney's fluid-solute balance adjustment and metabolic-endocrine functions resulting from a decrease in glomerular filtration rate. CKD affects approximately 10-15% of adults worldwide and 15.7% of adults in Turkey. Renal replacement treatment options for CKD are peritoneal dialysis, hemodialysis (HD) and kidney transplantation. The most common treatment method applied is HD. It was reported that 76% of patients with CKD in Turkey at the end of 2017 received HD treatment. The aim of HD is to correct the patient's fluid and electrolyte imbalance, prevent possible complications, compensate for the patient's lost renal functions as much as possible and increase the quality of life. However, in addition to these, diet causes negativities such as fluid restriction, depression, job loss, loss of role in family life, fear of death, and decreased self-care ability in HD patients. Self-care ability is defined as "a dynamic process that enables individuals to participate in health services". Lack of self-care ability makes it difficult to adapt to the disease. Therefore, it negatively affects the treatment and increases the cost of the disease. Self-care behaviors in HD patients include appropriate diet intake, regular medication use, compliance with fluid restriction, and coping with stress. Studies show that there is a correlation between the level of self-care in HD patients and compliance with treatment, health-enhancing behaviors, and the reduction of physical and psychological symptoms. For this reason, it is important to develop self-care ability in order to protect and improve the quality of life of HD patients and to prevent possible complications. The area that creates the most stress in HD and makes it difficult to comply with treatment is fluid restriction. Non-compliance with fluid restriction is reported as 30.6-95% in Turkey and 15.3-80% worldwide. As the disease progresses, HD patients lose their ability to form urine. Therefore, the amount of fluid consumed becomes important. In addition, excessive fluid loading in patients increases mortality rates. For this reason, fluid restriction control should be made a lifestyle in disease management. Nurses who respond to and intervene in patients' needs instantly have great duties and responsibilities. It can be said that nursing care and education are of great importance in solving existing or potential problems of individuals receiving HD treatment. Patient education, which is within the scope of the nurse's educational role, ensures that the patient is protected from possible complications, can control fluids, increases self-care ability, and gains behavioral changes related to their health. The effects of education given to HD patients on various parameters have been examined in the literature. However, no study examining the self-care ability and fluid restriction of education has been found. Therefore, this study was conducted to examine the effects of education given to patients receiving HD treatment on self-care ability and fluid control.
- Conditions
- Nurse's Role
- Being tested
- Education
- Keywords
- Hemodialysis, Patient Education, Self-Care Ability, Fluid Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Patients who agreed to participate in the study and met the inclusion criteria were interviewed face to face before the HD session and their verbal and written permissions were obtained by reading the voluntary consent form. The researcher interviewed the patients one-on-one and provided information about the purpose of the study and the training program. Then, scale forms were applied to the patients. In order not to interrupt the training and not to distract the patients in this group, a separate room in the Dialysis Unit was used during the training. The education booklet "Living with Hemodialysis" on hemodialysis management prepared in line with the literature was given to the patients by the researcher. The training of a patient lasted an average of 40-50 minutes. During and at the end of the training, the patients' questions were answered in the training room.
| Study group | Role | What they receive |
|---|---|---|
| Patient Education | Experimental | The intervention group was given 40-50 minutes of training. Receives: Other: Education |
| Control Group | No intervention | Routine nursing care was given to hemodialysis patients in this group without any training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care Ability Scale
Self-care ability scale, developed by Besey Ören in 2010, consists of 22 items and five sub-dimensions. These dimensions are; drug use (1, 2, 3, 4, 5, 18), diet (8, 9, 10, 11, 12), hygienic care (15, 16, 17, 19), mental state (20, 21, 22) and self-monitoring (6,7,13, 14). The scale is a 3-point Likert type (0: I never apply, 1: I sometimes apply, 2: I always apply). Items 12, 20, 21, 22 on the scale are scored negatively. The scores obtained from the scale range from 0 to 44. According to the scale, as the scores obtained increase, the self-care ability of patients receiving dialysis treatment increases.
Measured: Up to 8 weeks
Fluid Control Scale in Hemodialysis Patients
Fluid control scale in hemodialysis patients, developed by Coşar and Çınar in 2012 consists of 24 items and three sub-dimensions. These sub-dimensions are; knowledge (1-7), behavior (8-18) and attitude (19-24). The scale is a 3-point Likert type (1: Disagree, 2: Undecided, 3: Agree). Items 7, 18, 19, 20, 21, 22, 23 and 24 in the scale are scored negatively. Scores obtained from the scale range from 24 to 72. As the score obtained increases, the patients' compliance with fluid control increases.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start11 Apr 2023
- Primary completion12 Oct 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Yildirim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Yildirim, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534476
- Sponsor's protocol ID
- ZeynepY
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Hemodialysis Patients on Patients' Self-Care Ability and Fluid Control
- ClinicalTrials.gov ID
- NCT06534476
- Acronym / sponsor ID
- ZeynepY
- Conditions
- Nurse's Role
- Keywords
- Hemodialysis, Patient Education, Self-Care Ability, Fluid Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Zeynep YildirimUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 2 Aug 2024 (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 conducted to investigate the effects of education given to patients receiving hemodialysis treatment on self-care agency and fluid control. This study has a pre-test-post-test quasi-experimental design. A total of 54 hemodialysis patients who met the inclusion criteria were included in the study.
Detailed description
Chronic diseases are one of the major public health problems. Chronic renal failure (CKD) is among the chronic diseases that cause death worldwide. CKD is defined as a chronic and progressive deterioration in the kidney's fluid-solute balance adjustment and metabolic-endocrine functions resulting from a decrease in glomerular filtration rate. CKD affects approximately 10-15% of adults worldwide and 15.7% of adults in Turkey. Renal replacement treatment options for CKD are peritoneal dialysis, hemodialysis (HD) and kidney transplantation. The most common treatment method applied is HD. It was reported that 76% of patients with CKD in Turkey at the end of 2017 received HD treatment. The aim of HD is to correct the patient's fluid and electrolyte imbalance, prevent possible complications, compensate for the patient's lost renal functions as much as possible and increase the quality of life. However, in addition to these, diet causes negativities such as fluid restriction, depression, job loss, loss of role in family life, fear of death, and decreased self-care ability in HD patients. Self-care ability is defined as "a dynamic process that enables individuals to participate in health services". Lack of self-care ability makes it difficult to adapt to the disease. Therefore, it negatively affects the treatment and increases the cost of the disease. Self-care behaviors in HD patients include appropriate diet intake, regular medication use, compliance with fluid restriction, and coping with stress. Studies show that there is a correlation between the level of self-care in HD patients and compliance with treatment, health-enhancing behaviors, and the reduction of physical and psychological symptoms. For this reason, it is important to develop self-care ability in order to protect and improve the quality of life of HD patients and to prevent possible complications. The area that creates the most stress in HD and makes it difficult to comply with treatment is fluid restriction. Non-compliance with fluid restriction is reported as 30.6-95% in Turkey and 15.3-80% worldwide. As the disease progresses, HD patients lose their ability to form urine. Therefore, the amount of fluid consumed becomes important. In addition, excessive fluid loading in patients increases mortality rates. For this reason, fluid restriction control should be made a lifestyle in disease management. Nurses who respond to and intervene in patients' needs instantly have great duties and responsibilities. It can be said that nursing care and education are of great importance in solving existing or potential problems of individuals receiving HD treatment. Patient education, which is within the scope of the nurse's educational role, ensures that the patient is protected from possible complications, can control fluids, increases self-care ability, and gains behavioral changes related to their health. The effects of education given to HD patients on various parameters have been examined in the literature. However, no study examining the self-care ability and fluid restriction of education has been found. Therefore, this study was conducted to examine the effects of education given to patients receiving HD treatment on self-care ability and fluid control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Education | Experimental | Other: EducationThe intervention group was given 40-50 minutes of training. |
| Control Group | No intervention | –Routine nursing care was given to hemodialysis patients in this group without any training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years old and above
- Receiving dialysis treatment for at least three months
- Being literate
Key exclusion criteria (1 listed)
- Having communication problems
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 |
|---|---|---|
| EducationPatients who agreed to participate in the study and met the inclusion criteria were interviewed face to face before the HD session and their verbal and written permissions were obtained by reading the voluntary consent form. The researcher interviewed the patients one-on-one and provided information about the purpose of the study and the training program. Then, scale forms were applied to the patients. In order not to interrupt the training and not to distract the patients in this group, a separate room in the Dialysis Unit was used during the training. The education booklet "Living with Hemodialysis" on hemodialysis management prepared in line with the literature was given to the patients by the researcher. The training of a patient lasted an average of 40-50 minutes. During and at the end of the training, the patients' questions were answered in the training room. | Other | Patient Education |
Primary outcome
Self-Care Ability Scale
Time frame: Up to 8 weeks
Self-care ability scale, developed by Besey Ören in 2010, consists of 22 items and five sub-dimensions. These dimensions are; drug use (1, 2, 3, 4, 5, 18), diet (8, 9, 10, 11, 12), hygienic care (15, 16, 17, 19), mental state (20, 21, 22) and self-monitoring (6,7,13, 14). The scale is a 3-point Likert type (0: I never apply, 1: I sometimes apply, 2: I always apply). Items 12, 20, 21, 22 on the scale are scored negatively. The scores obtained from the scale range from 0 to 44. According to the scale, as the scores obtained increase, the self-care ability of patients receiving dialysis treatment increases.
Fluid Control Scale in Hemodialysis Patients
Time frame: Up to 8 weeks
Fluid control scale in hemodialysis patients, developed by Coşar and Çınar in 2012 consists of 24 items and three sub-dimensions. These sub-dimensions are; knowledge (1-7), behavior (8-18) and attitude (19-24). The scale is a 3-point Likert type (1: Disagree, 2: Undecided, 3: Agree). Items 7, 18, 19, 20, 21, 22, 23 and 24 in the scale are scored negatively. Scores obtained from the scale range from 24 to 72. As the score obtained increases, the patients' compliance with fluid control increases.
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 2 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Nurse's Role
Not yet recruiting
The Effect of Creative Drama on the Therapeutic Communication Skills and Empathy Levels of Pediatric Nursing Students: A Randomized Controlled Study
Nurse's Role, Empathy
Active, not recruiting
Advancing Nursing Practices in Hospital Oncology Care
Gastrointestinal Cancer, Gastrointestinal Disease
RecruitingPhase 1
Two Different Therapeutic Interventions Applied During Blood Sampling in Children
Blood Sampling, Child, Only
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Not yet recruitingObservational study
Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS
Experiences, Lived Experiences
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Nurse's Role, run by Zeynep Yildirim 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 3 inclusion and 1 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 2 Aug 2024. 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?
Self-Care Ability Scale (time frame: Up to 8 weeks). The study lists 2 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 2 Aug 2024.