Nurse's RoleNCT06604403
Effectiveness of Massage Applied to Hemodialysis Patients
A study testing Massage in people with Nurse's Role, run by Zeynep Yildirim at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of massage on comfort and fatigue levels of hemodialysis patients. 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?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2022to Dec 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
- Volunteering to participate in the study
- Being 18 years of age or older
- Receiving hemodialysis treatment in a dialysis unit for at least six months
- Not having a condition that prevents verbal communication
- Not having a psychiatric problem
Who cannot join
- Patients who left the study at any stage
- Patients who had been receiving hemodialysis treatment for less than 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University
Erzurum, Yakutiye, 25100
Zeynep YILDIRIM, 05365978465, zeynepyildirim@atauni.edu.tr
About this study
Official title: Effect of Massage Applied to Hemodialysis Patients on Comfort Level and Fatigue
This study was conducted to determine the effect of massage on comfort and fatigue levels of hemodialysis patients.
Read the detailed description
Chronic renal failure (CRF) is a health problem that causes significant mortality and morbidity worldwide. The prevalence of the disease is increasing worldwide, especially in developing countries. Hemodialysis (HD) is the most common treatment method for CRF in the world. Approximately 90% of patients with CRF receive HD treatment. Despite advances in technology and medical care due to HD treatment, patients experience many physical and psychosocial symptoms. It is emphasized that comfort is significantly negatively affected in HD patients due to reasons such as the direct impact of HD treatment on the daily and social lives of patients. Increasing the comfort level is important for the patient to continue their daily life activities. In addition, comfort is accepted as the basis of quality nursing care. Increasing the comfort levels of HD patients provides lower comorbidity and mortality rates and improvement in institutional patient outcomes. Fatigue, one of the physical symptoms seen in HD patients, affects 60-95% of patients. Fatigue increases the patients' dependency levels, reduces their physical capabilities, negatively affects the patient and their family economically and reduces their quality of life. Therefore, effective management of fatigue is of great importance for the patient. Despite affecting the patients' lives to this extent, fatigue and discomfort have often been overlooked and neglected symptoms due to their subjective nature. Various pharmacological and non-pharmacological treatment methods are used to control fatigue due to CRF or HD and to bring the desired patient comfort. One of the non-pharmacological methods is massage. Massage can be defined as scientific systematic manipulations applied to body tissues in order to affect the locomotor system and nervous system as well as the general circulation. There are studies in the literature where various applications are applied to HD patients to affect fatigue and comfort. However, it is striking that there is no study examining the effect of massage on the comfort and fatigue levels of patients receiving HD treatment. Therefore, the research was planned to examine the effect of massage on the comfort level and fatigue level of HD patients.
- Conditions
- Nurse's Role
- Being tested
- Massage
- Keywords
- Massage, Hemodialysis Patients, Nursing, Comfort, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
After the hemodialysis, the patients will receive a 15-20 minute hand and foot massage. This application will be applied to the patients in two weekly dialysis sessions for a total of 8 sessions for four weeks. Before starting the massage applications, the patient's hands and feet will be washed and dried thoroughly. The patients will be given a semi-sitting or lying position that they can feel comfortable in. Before starting the hand and foot massage, the researcher will gently rub and warm their hands and wrists. The massages will start with a hand massage. A foot massage will be performed after the hand massage. 3-5 drops of baby oil applied at room temperature will be used to reduce friction during the massage. Effleurage, petrissage and friction styles of the massage will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Massage Group | Experimental | Patients in the intervention group will receive post-hemodialysis massage twice a week for four weeks. Receives: Other: Massage |
| Control Group | No intervention | Routine nursing care was given to the patients in this group without any message. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodialysis Comfort Scale
The scale developed by Sahin Orak and his colleagues in 2017 consists of nine items and two sub-dimensions. These sub-dimensions are; "Relaxation" (7-9) and "Overcoming" (1- 6). The scale is a five-point Likert type (1: never -5: always). Items 1-3 and 5-9 of the scale are reverse coded. The lowest score that can be obtained from the scale is 9, the highest score is 45. The higher the score, the higher the comfort level.
Measured: Up to 4 weeks
Piper Fatigue Scale
The scale was developed by Barbara F. Piper and her friends in 1987 and adapted to Turkish by Can and her friends in 2001. The scale consists of 22 items and four sub-dimensions. These are; "Behavior/Violence" (2-7); "Affect" (8-12), "Sensory" (5 items; 13-17) and "Cognitive/Psychological" (18-23). In addition to this, there are five items (1 and 24-27) that are not used in calculating the fatigue score, but are recommended to remain in the scale because they are important in evaluating data related to fatigue. The scale is evaluated using a 0-10 Vizuel Analog Scale. The total score obtained from the scale is divided by the number of items. The minimum score that can be obtained from the scale is 0, and the maximum score is 10. The higher the score, the more fatigue the individual feels.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 May 2022
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- 58 participants (estimated)
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
- NCT06604403
- Sponsor's protocol ID
- Massage
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Massage Applied to Hemodialysis Patients on Comfort Level and Fatigue
- ClinicalTrials.gov ID
- NCT06604403
- Acronym / sponsor ID
- Massage
- Conditions
- Nurse's Role
- Keywords
- Massage, Hemodialysis Patients, Nursing, Comfort, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Zeynep YildirimUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Sep 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 determine the effect of massage on comfort and fatigue levels of hemodialysis patients.
Detailed description
Chronic renal failure (CRF) is a health problem that causes significant mortality and morbidity worldwide. The prevalence of the disease is increasing worldwide, especially in developing countries. Hemodialysis (HD) is the most common treatment method for CRF in the world. Approximately 90% of patients with CRF receive HD treatment. Despite advances in technology and medical care due to HD treatment, patients experience many physical and psychosocial symptoms. It is emphasized that comfort is significantly negatively affected in HD patients due to reasons such as the direct impact of HD treatment on the daily and social lives of patients. Increasing the comfort level is important for the patient to continue their daily life activities. In addition, comfort is accepted as the basis of quality nursing care. Increasing the comfort levels of HD patients provides lower comorbidity and mortality rates and improvement in institutional patient outcomes. Fatigue, one of the physical symptoms seen in HD patients, affects 60-95% of patients. Fatigue increases the patients' dependency levels, reduces their physical capabilities, negatively affects the patient and their family economically and reduces their quality of life. Therefore, effective management of fatigue is of great importance for the patient. Despite affecting the patients' lives to this extent, fatigue and discomfort have often been overlooked and neglected symptoms due to their subjective nature. Various pharmacological and non-pharmacological treatment methods are used to control fatigue due to CRF or HD and to bring the desired patient comfort. One of the non-pharmacological methods is massage. Massage can be defined as scientific systematic manipulations applied to body tissues in order to affect the locomotor system and nervous system as well as the general circulation. There are studies in the literature where various applications are applied to HD patients to affect fatigue and comfort. However, it is striking that there is no study examining the effect of massage on the comfort and fatigue levels of patients receiving HD treatment. Therefore, the research was planned to examine the effect of massage on the comfort level and fatigue level of HD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage Group | Experimental | Other: MassagePatients in the intervention group will receive post-hemodialysis massage twice a week for four weeks. |
| Control Group | No intervention | –Routine nursing care was given to the patients in this group without any message. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteering to participate in the study
- Being 18 years of age or older
- Receiving hemodialysis treatment in a dialysis unit for at least six months
- Not having a condition that prevents verbal communication
- Not having a psychiatric problem
Key exclusion criteria (2 listed)
- Patients who left the study at any stage
- Patients who had been receiving hemodialysis treatment for less than 6 months
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 |
|---|---|---|
| MassageAfter the hemodialysis, the patients will receive a 15-20 minute hand and foot massage. This application will be applied to the patients in two weekly dialysis sessions for a total of 8 sessions for four weeks. Before starting the massage applications, the patient's hands and feet will be washed and dried thoroughly. The patients will be given a semi-sitting or lying position that they can feel comfortable in. Before starting the hand and foot massage, the researcher will gently rub and warm their hands and wrists. The massages will start with a hand massage. A foot massage will be performed after the hand massage. 3-5 drops of baby oil applied at room temperature will be used to reduce friction during the massage. Effleurage, petrissage and friction styles of the massage will be applied. | Other | Massage Group |
Primary outcome
Hemodialysis Comfort Scale
Time frame: Up to 4 weeks
The scale developed by Sahin Orak and his colleagues in 2017 consists of nine items and two sub-dimensions. These sub-dimensions are; "Relaxation" (7-9) and "Overcoming" (1- 6). The scale is a five-point Likert type (1: never -5: always). Items 1-3 and 5-9 of the scale are reverse coded. The lowest score that can be obtained from the scale is 9, the highest score is 45. The higher the score, the higher the comfort level.
Piper Fatigue Scale
Time frame: Up to 4 weeks
The scale was developed by Barbara F. Piper and her friends in 1987 and adapted to Turkish by Can and her friends in 2001. The scale consists of 22 items and four sub-dimensions. These are; "Behavior/Violence" (2-7); "Affect" (8-12), "Sensory" (5 items; 13-17) and "Cognitive/Psychological" (18-23). In addition to this, there are five items (1 and 24-27) that are not used in calculating the fatigue score, but are recommended to remain in the scale because they are important in evaluating data related to fatigue. The scale is evaluated using a 0-10 Vizuel Analog Scale. The total score obtained from the scale is divided by the number of items. The minimum score that can be obtained from the scale is 0, and the maximum score is 10. The higher the score, the more fatigue the individual feels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynep YILDIRIM, Res. Ass. (05365978465, zeynepyildirim@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodialysis Comfort Scale (time frame: Up to 4 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 19 Sep 2024.