Symptom ClusterNCT05321966
The Effect of Video Training on Symptom Burden Patients Undergoing Hemodialysis Treatment
A study testing Visual video education in people with Symptom Cluster and Quality of Life, run by Halise Taskın Duman at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptom Cluster, Quality of Life, Conformity, Social
- What is being tested?
- Visual video education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 25 Dec 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old,
- Patients who have been treated for HD for 12 months or more
Who cannot join
- younger than 18,
- Initiation of HD treatment is less than 12 months,
- Vacation in HD center is within the scope of dialysis and less than 12 weeks that will come,
- Known hearing or vision problems,
- Patients with cognitive impairment,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman University
Muğla, Fethiye, 48300
About this study
Official title: The Effect of Video Training on Symptom Burden, Comfort Level and Quality of Life in Patients Undergoing Hemodialysis Treatment
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.
Read the detailed 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.
- Conditions
- Symptom Cluster, Quality of Life, Conformity, Social
- Being tested
- Visual video education
- Keywords
- Hemodialysis; Visual Education, Symptom Burden, Patient Comfort, Quality of Life
- Medical subject headings
- Syndrome, Social Conformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual video educationOther
The intervention group watched three episodes of a training video a week for 12 weeks. Each session started 90 minutes after the HD treatment
| Study group | Role | What they receive |
|---|---|---|
| Visual Education Group | Experimental | The intervention group watched three episodes of a training video a week for 12 weeks. Each session started 90 minutes after the HD treatment Receives: Other: Visual video education |
| no intervention | No intervention | No intervention was made to the individuals in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in symptom burden in hemordialysis patients
The dialysis-related symptoms of the patients were evaluated with the Dialysis Symptom Index. This scale is used by individuals in the last seven days. He questions his symptoms. The scale consists of 30 questions in 5-point Likert type. An increase in the scale score is symptom indicates an increased load.
Measured: Once a month/3 times
The change in comfort level in hemodialysis patients
Hemodialysis Comfort Scale Version II scale is a 5-point Likert type scale consisting of 26 items and six sub-dimensions. As the scale score increases, comfort increases, while as the score decreases, comfort decreases. The scale score range is min-max= 26-130 points. The scale consists of 6 dimensions in total. These dimensions are physical relaxation, physical relaxation, psychospiritual relaxation, psychospiritual empowerment, environmental empowerment, sociocultural relaxation.
Measured: Once a month/3 times
The change in quality of life in hemodialysis patients
The impairment in the patients' quality of life was evaluated with the Short Form of the Quality of Life Scale (SF 36). The scale consists of 36 questions and the last four weeks of the individuals are questioned. The scale consists of eight sub-dimensions. These dimensions are; physical function, physical role difficulty, emotional role difficulty, energy/vitality/vitality, mental health, social functionality, pain, general health perception. Each of the sub-dimensions is evaluated separately. On the scale, "0" indicates poor health, "100" indicates good health.
Measured: Once a month/3 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start15 Apr 2021
- Primary completion20 Jul 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom ClusterStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halise Taskın Duman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Halise Taskın Duman, Muğla Sıtkı Koçman University
- Investigators
- Halise Taskin Duman, Phd, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321966
- Sponsor's protocol ID
- FethiyeHSF
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video Training on Symptom Burden, Comfort Level and Quality of Life in Patients Undergoing Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT05321966
- Acronym / sponsor ID
- FethiyeHSF
- Conditions
- Symptom Cluster, Quality of Life, Conformity, Social
- Keywords
- Hemodialysis; Visual Education, Symptom Burden, Patient Comfort, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Halise Taskın DumanUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 11 Apr 2022 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Education Group | Experimental | Other: Visual video educationThe intervention group watched three episodes of a training video a week for 12 weeks. Each session started 90 minutes after the HD treatment |
| no intervention | No intervention | –No intervention was made to the individuals in the control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years old,
- Patients who have been treated for HD for 12 months or more
Key exclusion criteria (5 listed)
- younger than 18,
- Initiation of HD treatment is less than 12 months,
- Vacation in HD center is within the scope of dialysis and less than 12 weeks that will come,
- Known hearing or vision problems,
- Patients with cognitive impairment,
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 |
|---|---|---|
| Visual video educationThe intervention group watched three episodes of a training video a week for 12 weeks. Each session started 90 minutes after the HD treatment | Other | Visual Education Group |
Primary outcome
The change in symptom burden in hemordialysis patients
Time frame: Once a month/3 times
The dialysis-related symptoms of the patients were evaluated with the Dialysis Symptom Index. This scale is used by individuals in the last seven days. He questions his symptoms. The scale consists of 30 questions in 5-point Likert type. An increase in the scale score is symptom indicates an increased load.
The change in comfort level in hemodialysis patients
Time frame: Once a month/3 times
Hemodialysis Comfort Scale Version II scale is a 5-point Likert type scale consisting of 26 items and six sub-dimensions. As the scale score increases, comfort increases, while as the score decreases, comfort decreases. The scale score range is min-max= 26-130 points. The scale consists of 6 dimensions in total. These dimensions are physical relaxation, physical relaxation, psychospiritual relaxation, psychospiritual empowerment, environmental empowerment, sociocultural relaxation.
The change in quality of life in hemodialysis patients
Time frame: Once a month/3 times
The impairment in the patients' quality of life was evaluated with the Short Form of the Quality of Life Scale (SF 36). The scale consists of 36 questions and the last four weeks of the individuals are questioned. The scale consists of eight sub-dimensions. These dimensions are; physical function, physical role difficulty, emotional role difficulty, energy/vitality/vitality, mental health, social functionality, pain, general health perception. Each of the sub-dimensions is evaluated separately. On the scale, "0" indicates poor health, "100" indicates good health.
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 11 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Halise Taskin Duman, Phd principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual video education in people with Symptom Cluster and Quality of Life, run by Halise Taskın Duman 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 2 inclusion and 5 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 11 Apr 2022. 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?
The change in symptom burden in hemordialysis patients (time frame: Once a month/3 times). The study lists 3 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 11 Apr 2022.