Hemodialysis PatientsNCT04139759
THE EFFECT OF HAND AND FOOT MASSAGE ON FATIGUE IN HEMODIALYSIS PATIENTS
A study testing hand massage and foot massage in people with Hemodialysis Patients, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Hemodialysis patients face many problems related to disease and treatment, fatigue is stated as the most common of these problems. Therefore, The aim of this study is to examine the effect of hand massage and foot massage on fatigue in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- hand massage and foot massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2018to 11 Feb 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Taking HD therapy, in the dialysis unit of a public hospital in Turkey, between October 19, 2018 - February 11, 2019,
- Agree to participate in the study with a written permission,
- Over the age of 18,
- Open to communication with complete orientation,
- Speaks and understands Turkish
- Receiving HD treatment 3 times a week for 6 months and longer,
Show all 9Show fewer
- No loss of sensation, mass, fracture or ingrown toenail (onyxis),
- In the lower extremities; without pathological and tumoral disease, phlesis, embolism and no bleeding disorder related to amputation, fracture, infection, wound, skin disease, muscle and bones,
- Patients with a Standardized Mini Mental Test (SMMT) score of 24 or more, in patients older than 65 years,
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Quasi-experimental
Hemodialysis patients face many problems related to disease and treatment, fatigue is stated as the most common of these problems. Therefore, The aim of this study is to examine the effect of hand massage and foot massage on fatigue in hemodialysis patients.
Read the detailed description
In parallel with the recent technological advances in medicine, increasing the possibilities of diagnosis and treatment of diseases has increased the average life expectancy and the incidence of chronic diseases. Chronic renal failure (CRF), which is one of the increasing chronic diseases, has become an important public health problem due to its negative impact on quality of life both in the world and in our country, high morbidity, mortality and treatment costs. According to the Joint Report of the Turkish Ministry of Health and Turkish Nephrology Association; by the end of 2016, Renal Replacement Therapy (RRT) applied total 74,475 patients (including pediatric patients), RRT is applied and while the most common form of treatment has been found to be hemodialysis treatment with 76.12%. Unless a successful renal transplantation is performed, hemodialysis treatment required to be performed until the end of life and provides a longer life, but it also causes biological, psychological, social and economical problems arising from treatment. Fatigue, which often related to problems with its biological dimension, reduces the quality of life by adversely negatively affecting individual's daily life activities.
- Conditions
- Hemodialysis Patients
- Being tested
- hand massage, foot massage
- Keywords
- Nursing, Hemodialysis, Fatigue, Hand massage, Foot massage
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand massageOther
In the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks.
foot massageOther
Foot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times.
| Study group | Role | What they receive |
|---|---|---|
| hand massage group | Experimental | In the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks. Receives: Other: hand massage |
| Foot massages group | Experimental | Foot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times. Receives: Other: foot massage |
| control group | No intervention | The patients in the control group (n = 28) were not administered except nursing interventions in the HD unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Hemodialysis / 1st Measurement
In addition to verbal and written information, the first measurements were obtained by applying the Patient Presentation Form, Visual Similarity Scale for Fatigue to the patients who were taken to hand massage, foot massage and control groups before HD treatment. In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high.
Measured: first day
Secondary outcomes (1)
2 Weeks Later /2nd Measurement
At the end of the second week of the hand massage and foot massage applications, the second measurements were obtained by reapplying the Visual Similarity Scale for Fatigue scale to all three groups.In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high.
Measured: fifteenth day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start19 Oct 2018
- Primary completion20 Nov 2018
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan ÇEÇEN, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139759
- Sponsor's protocol ID
- massage
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified individual participate data for all primary and secondary outcome measures will be made available
Publications
Astroth KS, Russell CL, Welch JL. Non-pharmaceutical fatigue interventions in adults receiving hemodialysis: a systematic review. Nephrol Nurs J. 2013 Sep-Oct;40(5):407-27; quiz 428.
PubMed 24308108Ahmadidarrehsima S, Mohammadpourhodki R, Ebrahimi H, Keramati M, Dianatinasab M. Effect of foot reflexology and slow stroke back massage on the severity of fatigue in patients undergoing hemodialysis: A semi-experimental study. J Complement Integr Med. 2018 Sep 28;15(4). doi: 10.1515/jcim-2017-0183.
PubMed 30265652
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Quasi-experimental
- ClinicalTrials.gov ID
- NCT04139759
- Acronym / sponsor ID
- massage
- Conditions
- Hemodialysis Patients
- Keywords
- Nursing, Hemodialysis, Fatigue, Hand massage, Foot massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 25 Oct 2019 (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.
Hemodialysis patients face many problems related to disease and treatment, fatigue is stated as the most common of these problems. Therefore, The aim of this study is to examine the effect of hand massage and foot massage on fatigue in hemodialysis patients.
Detailed description
In parallel with the recent technological advances in medicine, increasing the possibilities of diagnosis and treatment of diseases has increased the average life expectancy and the incidence of chronic diseases. Chronic renal failure (CRF), which is one of the increasing chronic diseases, has become an important public health problem due to its negative impact on quality of life both in the world and in our country, high morbidity, mortality and treatment costs. According to the Joint Report of the Turkish Ministry of Health and Turkish Nephrology Association; by the end of 2016, Renal Replacement Therapy (RRT) applied total 74,475 patients (including pediatric patients), RRT is applied and while the most common form of treatment has been found to be hemodialysis treatment with 76.12%. Unless a successful renal transplantation is performed, hemodialysis treatment required to be performed until the end of life and provides a longer life, but it also causes biological, psychological, social and economical problems arising from treatment. Fatigue, which often related to problems with its biological dimension, reduces the quality of life by adversely negatively affecting individual's daily life activities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hand massage group | Experimental | Other: hand massageIn the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks. |
| Foot massages group | Experimental | Other: foot massageFoot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times. |
| control group | No intervention | –The patients in the control group (n = 28) were not administered except nursing interventions in the HD unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - Taking HD therapy, in the dialysis unit of a public hospital in Turkey, between October 19, 2018 - February 11, 2019,
- Agree to participate in the study with a written permission,
- Over the age of 18,
- Open to communication with complete orientation,
- Speaks and understands Turkish
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| hand massageIn the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks. | Other | hand massage group |
| foot massageFoot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times. | Other | Foot massages group |
Primary outcome
Pre-Hemodialysis / 1st Measurement
Time frame: first day
In addition to verbal and written information, the first measurements were obtained by applying the Patient Presentation Form, Visual Similarity Scale for Fatigue to the patients who were taken to hand massage, foot massage and control groups before HD treatment. In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high.
1 secondary outcome
2 Weeks Later /2nd Measurement
Time frame: fifteenth day
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 28 Oct 2019.
- Background: PubMed 24308108Astroth KS, Russell CL, Welch JL. Non-pharmaceutical fatigue interventions in adults receiving hemodialysis: a systematic review. Nephrol Nurs J. 2013 Sep-Oct;40(5):407-27; quiz 428.
- Results publication: PubMed 30265652Ahmadidarrehsima S, Mohammadpourhodki R, Ebrahimi H, Keramati M, Dianatinasab M. Effect of foot reflexology and slow stroke back massage on the severity of fatigue in patients undergoing hemodialysis: A semi-experimental study. J Complement Integr Med. 2018 Sep 28;15(4). doi: 10.1515/jcim-2017-0183.
- Individual participant dataSharing planned: Yes. de-identified individual participate data for all primary and secondary outcome measures will be made available
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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.
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 hand massage and foot massage in people with Hemodialysis Patients, run by Mersin University 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 9 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 28 Oct 2019. 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?
Pre-Hemodialysis / 1st Measurement (time frame: first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139759, which also lists 2 linked publications.
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 28 Oct 2019.