FatigueacupressNCT05892679
The Effect of Acupressure in Hemodialysis Patients
A study testing acupressure in people with Fatigue and Comfort, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluates the effect of acupressure application on fatigue, quality of life and comfort in hemodialysis patients. In our research, it is aimed to reduce fatigue, increase the quality of life and comfort level in hemodialysis patients with acupressure applied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Comfort, Quality of Life
- What is being tested?
- acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 30 Sep 2023
- 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
- Written and verbal consent was obtained to participate in the study,
- Can read, write, speak and understand Turkish,
- Are older than 18 years,
- Have received HD treatment for at least 6 months,
- Receiving HD treatment 3 times a week,
- Fatigue severity ≥4, using a single-item fatigue index ranging from 0 to 10 points,
Show all 11Show fewer
- Absence of lower extremity wounds
- Any complementary therapy
- Conscious, fully oriented and cooperative and open to communication,
- No visual, hearing and perception problems,
- Any psychiatric patient
Who cannot join
- Wound or amputation of lower extremities, rheumatoid arthritis or limb fracture
- Any psychiatric disease,
- Patients with hepatitis B and hepatitis C,
- Using any of the complementary and integrated methods
- Those who receive HD treatment twice a week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study
This randomized controlled study evaluates the effect of acupressure application on fatigue, quality of life and comfort in hemodialysis patients. In our research, it is aimed to reduce fatigue, increase the quality of life and comfort level in hemodialysis patients with acupressure applied.
Read the detailed description
In the study, 60 hemodialysis patients were randomly assigned to the study and control groups. The study group (n=30) Acupressure is formulated according to the standards of the World Health Organization and in a certain order to the points of Stomach 36 (St 36), Gall Bladder 34 point (GB 34), Spleen 6 point (SP 6) and Kidney 1 point (K 1) will be applied. Consideration will be given to the appropriate pressure intensity and duration. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. Considering the anatomical area where the point is located, the most suitable thumb, index and/or middle finger will be used for application to the relevant point. Successive compressions will be applied at a frequency that does not disturb the patient, does not cause pain, and has a calming effect. Considering the studies done, a person will be given acupressure three times a week for four weeks. No intervention will be made to the control group (n=30). In order to avoid ethical problems both groups will be given an informative training on acupressure and fatigue, increase the quality of life and comfort level in hemodialysis patients at the end of the study. The primary outcome of the study is the effect of acupuncture on fatigue in hemodialysis patients. The secondary result of the study is the effect of acupuncture on quality of life and comfort level in hemodialysis patients.
The results will be collected before the acupressure and in the 4th week of the last intervention.
- Conditions
- Fatigue, Comfort, Quality of Life
- Being tested
- acupressure
- Keywords
- acupressure, hemodialysis patients, Fatigue, Comfort, Quality of Life
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
Acupressure will be formulated according to the standards of the World Health Organization and applied to the determined points in a certain order. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. A total of 8 points with parallel points will be studied, with four points in each lower extremity. There will be a total of 12 minutes of pressure on 8 points, with an average of 90 seconds on each point, and approximately 10-15 seconds of warming and preparatory scrubbing before pressing on the area where the points are located.
Considering the studies done, a person will be given acupressure three times a week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | Acupressure will be formulated according to the standards of the World Health Organization and applied to the determined points in a certain order. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. A total of 8 points with parallel points will be studied, with four points in each lower extremity. There will be a total of 12 minutes of pressure on 8 points, with an average of 90 seconds on each point, and approximately 10-15 seconds of warming and preparatory scrubbing before pressing on the area where the points are located.
Considering the studies done, a person will be given acupressure three times a week for four weeks. Receives: Other: acupressure |
| Control | No intervention | No intervention will be made to the control group only the data will be collected at the same time as the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue to be evaluated using the Piper Fatigue Scale
The total score obtained from the scale varies between 0 and 10 and as the score increases, the fatigue experienced by the individuals increases.
Measured: Change from before implementation and 4th week of practice
Secondary outcomes (2)
Life Quality to be evaluated using Kidney Disease and Quality of Life Short Form (KDQOL-SF 1.3)
Scores on each dimension range from 0 to 100, with higher scores reflecting better health related quality of life.
Measured: Change from before implementation and 4th week of practice
Comfort to be evaluated using Hemodialysis Comfort Scale
The score that can be obtained from the scale varies between 9 and 45. There is an inverse item in the scale.
Measured: Change from before implementation and 4th week of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start30 May 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Model description
- Prospective, randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VECİHE DÜZEL GÜNDÜZ, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892679
- Sponsor's protocol ID
- MersinUnv.VDG
- Acronym
- acupress
- Status last verified
- Jun 2024
- First submitted
- 27 May 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be used outside of this research.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05892679
- Acronym / sponsor ID
- acupress / MersinUnv.VDG
- Conditions
- Fatigue, Comfort, Quality of Life
- Keywords
- acupressure, hemodialysis patients, Fatigue, Comfort, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 7 Jun 2023 (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 randomized controlled study evaluates the effect of acupressure application on fatigue, quality of life and comfort in hemodialysis patients. In our research, it is aimed to reduce fatigue, increase the quality of life and comfort level in hemodialysis patients with acupressure applied.
Detailed description
In the study, 60 hemodialysis patients were randomly assigned to the study and control groups. The study group (n=30) Acupressure is formulated according to the standards of the World Health Organization and in a certain order to the points of Stomach 36 (St 36), Gall Bladder 34 point (GB 34), Spleen 6 point (SP 6) and Kidney 1 point (K 1) will be applied. Consideration will be given to the appropriate pressure intensity and duration. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. Considering the anatomical area where the point is located, the most suitable thumb, index and/or middle finger will be used for application to the relevant point. Successive compressions will be applied at a frequency that does not disturb the patient, does not cause pain, and has a calming effect. Considering the studies done, a person will be given acupressure three times a week for four weeks. No intervention will be made to the control group (n=30). In order to avoid ethical problems both groups will be given an informative training on acupressure and fatigue, increase the quality of life and comfort level in hemodialysis patients at the end of the study. The primary outcome of the study is the effect of acupuncture on fatigue in hemodialysis patients. The secondary result of the study is the effect of acupuncture on quality of life and comfort level in hemodialysis patients.
The results will be collected before the acupressure and in the 4th week of the last intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Other: acupressureAcupressure will be formulated according to the standards of the World Health Organization and applied to the determined points in a certain order. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. A total of 8 points with parallel points will be studied, with four points in each lower extremity. There will be a total of 12 minutes of pressure on 8 points, with an average of 90 seconds on each point, and approximately 10-15 seconds of warming and preparatory scrubbing before pressing on the area where the points are located. Considering the studies done, a person will be given acupressure three times a week for four weeks. |
| Control | No intervention | –No intervention will be made to the control group only the data will be collected at the same time as the study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written and verbal consent was obtained to participate in the study,
- Can read, write, speak and understand Turkish,
- Are older than 18 years,
- Have received HD treatment for at least 6 months,
- Receiving HD treatment 3 times a week,
Key exclusion criteria (5 listed)
- Wound or amputation of lower extremities, rheumatoid arthritis or limb fracture
- Any psychiatric disease,
- Patients with hepatitis B and hepatitis C,
- Using any of the complementary and integrated methods
- Those who receive HD treatment twice a week
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 |
|---|---|---|
| acupressureAcupressure will be formulated according to the standards of the World Health Organization and applied to the determined points in a certain order. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. A total of 8 points with parallel points will be studied, with four points in each lower extremity. There will be a total of 12 minutes of pressure on 8 points, with an average of 90 seconds on each point, and approximately 10-15 seconds of warming and preparatory scrubbing before pressing on the area where the points are located. Considering the studies done, a person will be given acupressure three times a week for four weeks. | Other | Acupressure |
Primary outcome
Fatigue to be evaluated using the Piper Fatigue Scale
Time frame: Change from before implementation and 4th week of practice
The total score obtained from the scale varies between 0 and 10 and as the score increases, the fatigue experienced by the individuals increases.
2 secondary outcomes
Life Quality to be evaluated using Kidney Disease and Quality of Life Short Form (KDQOL-SF 1.3)
Time frame: Change from before implementation and 4th week of practice
Comfort to be evaluated using Hemodialysis Comfort Scale
Time frame: Change from before implementation and 4th week of practice
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 Jun 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be used outside of this research.
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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 acupressure in people with Fatigue and Comfort, 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 11 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 28 Jun 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?
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?
Fatigue to be evaluated using the Piper Fatigue Scale (time frame: Change from before implementation and 4th week of practice). 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 28 Jun 2024.