HemodialysisNCT06416384
Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients
A study testing Hand Massage Group in people with Hemodialysis and Fatigue, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effect of hand massage on patients receiving HD treatment on the severity of post-dialysis fatigue and post-dialysis recovery time. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hemodialysis, Fatigue, Massage
- What is being tested?
- Hand Massage Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2024to 7 Nov 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those who are 18 years or older,
- Receiving hemodialysis treatment for at least 3 months,
- Receiving hemodialysis treatment three times a week,
- Does not have any open wounds in the area to be applied,
- No active fistula in the arm to be treated,
- Does not have a hearing impairment,
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- Sufficient to understand the questions,
- Open to communication and cooperation,
- Volunteer and willing for research
Who cannot join
- Having an active oncological problem or receiving oncological treatment,
- Those with health problems that require contact isolation,
- The number of dialysis sessions changed during the study,
- Those who lost their lives while working,
- Those who had a kidney transplant during the study,
- Those who want to leave voluntarily at any stage of the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Amasya University İnstitute of Health Sciences
Amasya, Merkez, 05100
About this study
Official title: The Effect of Hand Massage on Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients
This study aims to examine the effect of hand massage on patients receiving HD treatment on the severity of post-dialysis fatigue and post-dialysis recovery time.
Read the detailed description
After obtaining the necessary permissions for the research, informing the patients about the purpose, importance and method of the study by the researcher, and having the volunteer patients read and sign a consent form, the patients were randomly divided into two groups. Randomization of the groups was done in a computer environment.
- Conditions
- Hemodialysis, Fatigue, Massage
- Being tested
- Hand Massage Group, Control Group
- Keywords
- hemodialysis patient, fatique, hand massage, nursing, recovery time
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Massage GroupOther
Also called Experimental
The patients in the hand massage application group were asked by the researcher; Hand massage with olive oil was applied 12 times in total, three times a week for four weeks. No application was made to the side with fistula.
Control GroupOther
Also called Control
Patients in the control group received routine nursing care in the clinic for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hand Massage Group | Experimental | The researcher applied a hand massage to the hand area of the patients in the experimental group on the side without fistula for five minutes, three times a week for four weeks. Receives: Other: Control Group |
| Control Group | Other | Patients in the control group received routine nursing care in the clinic for four weeks. Receives: Other: Hand Massage Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue severity
Fatigue severity was evaluated before starting the application (pre-test)
Post-Dialysis Fatigue Scale: Kodama et al. The "Post-Dialysis Fatigue Scale" developed by (2020) is a five-item likert type scale consisting of 13 items. The scale is used to evaluate the severity of fatigue by examining the factors associated with fatigue observed after the end of treatment in dialysis patients. According to Özen et al. (2021) the total number of items in the scale after Turkish validity and reliability made by is 11.
Measured: one week= first session
recovery time
Recovery time after dialysis was evaluated before starting the application (pre-test)
Measured: One week= first session
Secondary outcomes (2)
fatique severity
The effect of hand massage on fatigue severity was measured
Post-Dialysis Fatigue Scale: Kodama et al. The "Post-Dialysis Fatigue Scale" developed by (2020) is a five-item likert type scale consisting of 13 items. The scale is used to evaluate the severity of fatigue by examining the factors associated with fatigue observed after the end of treatment in dialysis patients. According to Özen et al. (2021) the total number of items in the scale after Turkish validity and reliability made by is 11.
Measured: After 4 weeks
recovery time after dialysis
The effect of hand massage on recovery time after dialysis was measured
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start9 Jan 2024
- Primary completion7 Feb 2024
- Study completion7 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized controlled, single-blind, experimental study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eylem Topbaş, Phd, Study director, Amasya UniversitySeyit Ahmet KORKMAZ, Principal investigator, Amasya University health sciences institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416384
- Sponsor's protocol ID
- AU-SBE-SA-02
- Status last verified
- Aug 2024
- First submitted
- 10 May 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It can only be shared after publication upon special request from the authors.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Massage on Post-Dialysis Fatigue and Recovery Time in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06416384
- Acronym / sponsor ID
- AU-SBE-SA-02
- Conditions
- Hemodialysis, Fatigue, Massage
- Keywords
- hemodialysis patient, fatique, hand massage, nursing, recovery time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Nov 2024 (estimated)
- First posted
- 16 May 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 aims to examine the effect of hand massage on patients receiving HD treatment on the severity of post-dialysis fatigue and post-dialysis recovery time.
Detailed description
After obtaining the necessary permissions for the research, informing the patients about the purpose, importance and method of the study by the researcher, and having the volunteer patients read and sign a consent form, the patients were randomly divided into two groups. Randomization of the groups was done in a computer environment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It is a randomized controlled, single-blind, experimental study.
| Arm | Type | Receives |
|---|---|---|
| Hand Massage Group | Experimental | Other: Control GroupThe researcher applied a hand massage to the hand area of the patients in the experimental group on the side without fistula for five minutes, three times a week for four weeks. |
| Control Group | Other | Other: Hand Massage GroupPatients in the control group received routine nursing care in the clinic for four weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Those who are 18 years or older,
- Receiving hemodialysis treatment for at least 3 months,
- Receiving hemodialysis treatment three times a week,
- Does not have any open wounds in the area to be applied,
- No active fistula in the arm to be treated,
Key exclusion criteria (6 listed)
- Having an active oncological problem or receiving oncological treatment,
- Those with health problems that require contact isolation,
- The number of dialysis sessions changed during the study,
- Those who lost their lives while working,
- Those who had a kidney transplant during the study,
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 Massage GroupAlso: ExperimentalThe patients in the hand massage application group were asked by the researcher; Hand massage with olive oil was applied 12 times in total, three times a week for four weeks. No application was made to the side with fistula. | Other | Control Group |
| Control GroupAlso: ControlPatients in the control group received routine nursing care in the clinic for four weeks. | Other | Hand Massage Group |
Primary outcome
fatigue severity
Time frame: one week= first session
Fatigue severity was evaluated before starting the application (pre-test) Post-Dialysis Fatigue Scale: Kodama et al. The "Post-Dialysis Fatigue Scale" developed by (2020) is a five-item likert type scale consisting of 13 items. The scale is used to evaluate the severity of fatigue by examining the factors associated with fatigue observed after the end of treatment in dialysis patients. According to Özen et al. (2021) the total number of items in the scale after Turkish validity and reliability made by is 11.
recovery time
Time frame: One week= first session
Recovery time after dialysis was evaluated before starting the application (pre-test)
2 secondary outcomes
fatique severity
Time frame: After 4 weeks
recovery time after dialysis
Time frame: After 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No. It can only be shared after publication upon special request from the authors.
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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.
Eylem Topbaş, Phd study director
Amasya University
Seyit Ahmet KORKMAZ principal investigator
Amasya University health sciences institute
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 Group in people with Hemodialysis and Fatigue, run by Amasya 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 6 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 7 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?
Results are not available in the source record.
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?
fatigue severity (time frame: one week= first session). 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 7 Aug 2024.