Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05321966 |
| Other study ID # |
FethiyeHSF |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2021 |
| Est. completion date |
December 25, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Mugla Sitki Koçman University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: This study aimed to examine the impacts of video training support on the symptom
burden, comfort level and quality of life (QoL) of the patients undergoing hemodialysis (HD)
treatment. Methods: The current study adopted a randomized controlled quasi-experimental
research design to investigate the implications of video training support on the symptom
burden, comfort level and QoL of 48 participant patients, 22 of whom were in control and 26
were in intervention group, at Mugla Fethiye State Hospital Hemodialysis Center and a private
hemodialysis center between April 2021 and July 2021. Data collection was conducted through
Dialysis Symptom Index (DSI), Patient Information Form, QoL Scale Short Form (SF 36), and
Hemodialysis Comfort Scale (HDCS) Version II. The data was collected four times, in week 0
(1st measurement), 4th week (2nd measurement), 8th week (3rd measurement), and 12th week (4th
measurement). The intervention group watched three episodes of a training video a week for 12
weeks. Each session started 90 minutes after the HD treatment. The control group was shown
the training video at the end of the research. Necessary ethics committee, institutional
permissions and written consents of the participant patients were obtained prior to the
study.
Description:
The purpose of hemodialysis treatment; to remove metabolic wastes from the blood, to reduce
symptoms and complications in patients, and to increase life expectancy and quality. During
HD treatment, many comorbidities, complications and symptoms may occur in patients. Alvarez
et al. (2020) found diabetes and hypertension as comorbid diseases in the majority of the
patients, and the most common symptoms were found to be fatigue, cramps, hypotension,
headache, itching, difficulty concentrating, and dizziness.
In order to increase the success of hemodialysis treatment, the patient should make a
lifestyle change, comply with the treatment and his family should support the patient.
Compliance with treatment is ensured by the cooperation of the healthcare team with the
patient and their relatives. As treatment compliance increases, symptom burden, complication
and mortality rates decrease. For this, patients should be provided with planned trainings
that are repeated at the beginning of HD treatment and at regular intervals thereafter.
The purpose of patient education; To create a healthy behavioral change in patients, to
enable healthcare professionals to establish a more efficient relationship with the patient
and his family, to increase the quality of life of the patient and his family, to increase
the comfort of life, compliance with treatment, to reduce morbidity and mortality, and to
reduce the cost of health expenses. In our country, there is no standard educational content
and training calendar in HD units. Most of the lives of HD patients are spent in dialysis
units. The majority of the patients spend their time in the dialysis unit for an average of
four hours a day, three days a week, depending on the machine. For this reason, it is
important for patients to give the training to be given during the dialysis sessions.
The research was carried out as a randomized controlled quasi-experimental study with the aim
of examining the effect of video education support on patients who were treated with HD on
symptom burden, comfort level and quality of life. The research was carried out in Muğla
Fethiye State Hospital Hemodialysis Center and Private Fethiye Can Dialysis Center between
April 2021 and July 2021. The universe of the research; Patients who received treatment at
Fethiye State Hospital Hemodialysis Center and Private Fethiye Can Dialysis Center were
formed. The number of patients in Fethiye State Hospital Hemodialysis Center is 44, the
number of patients in Private Can Dialysis Center is 137, and a total of 181 patients receive
hemodialysis treatment in two centers.
Sample of the Research; The sample size of the study was 0.25 effect size, 0.05 error level,
95% confidence interval and 95% power of 4 measurements in both groups, 18 interventions and
18 control groups, in order to be able to analyze the variance in repeated measurements
within the factors in the study by using the G power 3.1.5 software program. It has been
calculated that a total of 36 participants are needed.
Simple random sampling method was used in the randomization of the study. The individuals in
the study were divided into clusters according to the session days. After clustering, a
simple random draw (by flipping a coin) was drawn to determine which cluster would be in the
intervention group and which cluster would be in the control group. The advantage of this
sampling method is that it is simple and easy to implement.
Preparation of Training Video Content The topics to be included in the content of the
training video were determined according to the educational needs of the patients by making a
literature review (TND reports, KDIGO guidelines, research articles).
Education subject titles; Fistula description, dry weight description, fluid intake and
weight control, diet, medication, skin care, oral care, exercises, infections, Sexual life
Data Collection An episode of video was watched by the intervention group, 90 minutes after
the start of HD, in each session three days a week for 12 weeks. In the weekly training plan
of the initiative group; The weekly training process was completed by watching a total of 3
training videos per week. No intervention was made in the control group.
The patients in the intervention group were provided with external memory and individual
headphones for video monitoring. External memories were not given to the patients, they were
only used by the researcher during the study.
The data were collected by the principal investigator by means of a face-to-face interview
and a question-answer questionnaire method, after obtaining the written consent of the
patients. At the beginning of the study, the patients in the control and intervention groups
were given the Patient Identification Form, Dialysis Symptom Index, Hemodialysis Comfort
Scale Version-II, Quality of Life Scale Short Form (SF 36) has been applied. At the end of
the fourth, eighth and twelfth weeks, Dialysis Symptom Index, Hemodialysis Comfort
Scale-Version II, Quality of Life Scale Short Form (SF 36) were applied to both groups. Data
collection time lasted an average of 15-20 minutes.
