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HemodialysisNCT05575193

Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis

A study testing Acupressure in people with Hemodialysis and Uremic Pruritus, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The research is to explore the effect of acupressure on uremic pruritus and sleep quality among patients receiving hemodialysis. The research method adopts the experimental research method using randomization. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hemodialysis, Uremic Pruritus
What is being tested?
Acupressure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteTaiwan
Study dates
15 Mar 2021to 31 Dec 2022
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 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • At least 3 months hemodialysis
  • At least 1 month have itching
  • At least mild itching on the 5D tickling scale (9-11 points)
  • Can answer questions correctly

Who cannot join

  • Skin-related disease
  • Liver disease
  • Psychiatric disorder
  • Cancer undergoing chemotherapy or radiation therapy
  • Nerve or vascular or soft tissue diseases of the extremitie
  • Infections or surgeries on the extremitie

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Xuan-Yi Huang

    Taipei, Peitou, 11219

Other trials in Taiwan

About this study

Official title: The Effect of Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis

The research is to explore the effect of acupressure on uremic pruritus and sleep quality among patients receiving hemodialysis. The research method adopts the experimental research method using randomization. The patients receiving the intervention of acupressure are in the experimental group, while those who do not receive it are in the control group.

Read the detailed description

There are about 60-90% of hemodialysis patients complain of itchy skin, which can cause the sleep quality decline. The important issue of non-invasive acupressure methods to relieve skin itching symptoms and to improve sleep quality are worth explored. Therefore, the research is to explore the effect of acupressure on uremic pruritus and sleep quality among patients receiving hemodialysis. The research method adopts the experimental research method using randomization. The patients receiving the intervention of acupressure are in the experimental group, while those who do not receive it are in the control group. The experimental group will receive the acupressure at the hemodialysis center for a total of 12 weeks, three times a week. The patients will receive 4 acupuncture points, including Quchi acupoint, Xuehai acupoint, Sanyinjiao acupoint, and Zusanli acupoint. Each acupoint will be pressed for 3 minutes, and totally 4 acupuncture points are 12 minutes. The effectiveness will be evaluated at the fourth week, eighth week and twelfth week. The effectiveness assessment in the study will use the "Visual Analog Scale (VAS)", "5D Pruritus Scale", and "Pittsburgh Sleep Quality Scale". This study uses the pre-test before the implementation of acupuncture, and uses the post-test at week 4, 8, and 12 end of acupuncture. Hopefully, this study may develop a beneficial non-drug care measures to improve the itching symptoms and sleep quality of hemodialysis patients, and to improve their quality of life. If this research result proves that the application of acupressure can be effective, it can not only improve the symptoms of itchy skin and sleep problems in hemodialysis patients, but also hope that can be extended to patients with end-stage renal disease.

Being tested
Acupressure
Keywords
Hemodialysis, Acupressure, Uremic Pruritus, Sleep Quality, Effect
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupressureOther

    The patients will receive 4 acupuncture points, including Quchi acupoint, Xuehai acupoint, Sanyinjiao acupoint, and Zusanli acupoint. Each acupoint will be pressed for 3 minutes, and totally 4 acupuncture points are 12 minutes.

Study groups in NCT05575193
Study groupRoleWhat they receive
Acupressure GroupExperimentalThe patients receiving the intervention of acupressure are in the experimental group.The experimental group will receive the acupressure at the hemodialysis center for a total of 12 weeks, three times a week. The patients will receive 4 acupuncture points, including Quchi acupoint, Xuehai acupoint, Sanyinjiao acupoint, and Zusanli acupoint. Each acupoint will be pressed for 3 minutes, and totally 4 acupuncture points are 12 minutes. The effectiveness will be evaluated at the fourth week, eighth week and twelfth week.
Receives: Other: Acupressure
Non-Acupressure GroupNo interventionAcupressure is not provided, only general routines are performed. Pre-test and 3 post-tests of "Visual Analog Scale (VAS)", "5D Tickling Scale", and "Pittsburgh Sleep Quality Scale" are also required (week 4, week 8 and week 12).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburgh Sleep Quality Index

    The scale contains seven indicators (subjective sleep quality, sleep lag period, total sleep hours, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction). Each indicator has its own special scoring method. Indicators are calculated on a scale of 0-3, with a total score ranging from 0-21. The total score of the seven indicators is more than 5 points, the quality of sleep is poor, and the score is less than 5 points, the quality of sleep is good, which means that the higher the score, the worse the quality of sleep.

    Measured: Pre-test

  2. Pittsburgh Sleep Quality Index

    The scale contains seven indicators (subjective sleep quality, sleep lag period, total sleep hours, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction). Each indicator has its own special scoring method. Indicators are calculated on a scale of 0-3, with a total score ranging from 0-21. The total score of the seven indicators is more than 5 points, the quality of sleep is poor, and the score is less than 5 points, the quality of sleep is good, which means that the higher the score, the worse the quality of sleep.

    Measured: Post-test at week 4

  3. Pittsburgh Sleep Quality Index

    The scale contains seven indicators (subjective sleep quality, sleep lag period, total sleep hours, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction). Each indicator has its own special scoring method. Indicators are calculated on a scale of 0-3, with a total score ranging from 0-21. The total score of the seven indicators is more than 5 points, the quality of sleep is poor, and the score is less than 5 points, the quality of sleep is good, which means that the higher the score, the worse the quality of sleep.

    Measured: Post-test at week 8

  4. Pittsburgh Sleep Quality Index

    The scale contains seven indicators (subjective sleep quality, sleep lag period, total sleep hours, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction). Each indicator has its own special scoring method. Indicators are calculated on a scale of 0-3, with a total score ranging from 0-21. The total score of the seven indicators is more than 5 points, the quality of sleep is poor, and the score is less than 5 points, the quality of sleep is good, which means that the higher the score, the worse the quality of sleep.

    Measured: Post-test at week 12

  5. Visual analogue scale

    Is a subjective feeling, no itching = 0, very intense itching = 10, mainly to assess the intensity of the itching

    Measured: Pre-test

  6. Visual analogue scale

    Is a subjective feeling, no itching = 0, very intense itching = 10, mainly to assess the intensity of the itching

    Measured: Post-test at week 4

  7. Visual analogue scale

    Is a subjective feeling, no itching = 0, very intense itching = 10, mainly to assess the intensity of the itching

    Measured: Post-test at week 8

  8. Visual analogue scale

    Is a subjective feeling, no itching = 0, very intense itching = 10, mainly to assess the intensity of the itching

    Measured: Post-test at week 12

  9. 5D Pruritus Scale

    It includes five items to assess: duration of tickling, degree of tickling, changes in tickling, effects of tickling on daily life (sleep, rest/social activities, housework/going out, work/class), and distribution of tickling, and the five items add up to a 5D tickling scale score, with a minimum of 5 points and a maximum of 25 points. Graded degree of itching: no tickling (≤ 8), mild tickling (9-11), moderate tickling (12-17), severe tickling (18-21), very severe itching (≥22)

    Measured: Pre-test

  10. 5D Pruritus Scale

    It includes five items to assess: duration of tickling, degree of tickling, changes in tickling, effects of tickling on daily life (sleep, rest/social activities, housework/going out, work/class), and distribution of tickling, and the five items add up to a 5D tickling scale score, with a minimum of 5 points and a maximum of 25 points. Graded degree of itching: no tickling (≤ 8), mild tickling (9-11), moderate tickling (12-17), severe tickling (18-21), very severe itching (≥22)

    Measured: Post-test at week 4

  11. 5D Pruritus Scale

    It includes five items to assess: duration of tickling, degree of tickling, changes in tickling, effects of tickling on daily life (sleep, rest/social activities, housework/going out, work/class), and distribution of tickling, and the five items add up to a 5D tickling scale score, with a minimum of 5 points and a maximum of 25 points. Graded degree of itching: no tickling (≤ 8), mild tickling (9-11), moderate tickling (12-17), severe tickling (18-21), very severe itching (≥22)

    Measured: Post-test at week 8

  12. 5D Pruritus Scale

    It includes five items to assess: duration of tickling, degree of tickling, changes in tickling, effects of tickling on daily life (sleep, rest/social activities, housework/going out, work/class), and distribution of tickling, and the five items add up to a 5D tickling scale score, with a minimum of 5 points and a maximum of 25 points. Graded degree of itching: no tickling (≤ 8), mild tickling (9-11), moderate tickling (12-17), severe tickling (18-21), very severe itching (≥22)

    Measured: Post-test at week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2022
  2. Study start15 Mar 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients receiving the intervention of acupressure are in the experimental group, while those who do not receive it are in the control group. The experimental group will receive the acupressure at the hemodialysis center for a total of 12 weeks, three times a week. The patients will receive 4 acupuncture points, including Quchi acupoint, Xuehai acupoint, Sanyinjiao acupoint, and Zusanli acupoint. Each acupoint will be pressed for 3 minutes, and totally 4 acupuncture points are 12 minutes. The effectiveness will be evaluated at the fourth week, eighth week and twelfth week. The effectiveness assessment in the study will use the "Visual Analog Scale (VAS)", "5D Pruritus Scale", and "Pittsburgh Sleep Quality Scale".
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05575193
Sponsor's protocol ID
202102EM001
Status last verified
Mar 2023
First submitted
28 Sep 2022
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Che-Yi C, Wen CY, Min-Tsung K, Chiu-Ching H. Acupuncture in haemodialysis patients at the Quchi (LI11) acupoint for refractory uraemic pruritus. Nephrol Dial Transplant. 2005 Sep;20(9):1912-5. doi: 10.1093/ndt/gfh955. Epub 2005 Jun 28.

    PubMed 15985509
  • Badiee Aval S, Ravanshad Y, Azarfar A, Mehrad-Majd H, Torabi S, Ravanshad S. A Systematic Review and Meta-analysis of Using Acupuncture and Acupressure for Uremic Pruritus. Iran J Kidney Dis. 2018 Mar;12(2):78-83.

    PubMed 29507269
  • Kilic Akca N, Tasci S, Karatas N. Effect of acupressure on patients in Turkey receiving hemodialysis treatment for uremic pruritus. Altern Ther Health Med. 2013 Sep-Oct;19(5):12-8.

    PubMed 23981400
  • Kilic Akca N, Tasci S. Acupressure and Transcutaneous Electrical Acupoint Stimulation for Improving Uremic Pruritus: A Randomized, Controlled Trial. Altern Ther Health Med. 2016 Mar;22(3):18-24.

    PubMed 27228268
  • Karjalian F, Momennasab M, Yoosefinejad AK, Jahromi SE. The Effect of Acupressure on the Severity of Pruritus and Laboratory Parameters in Patients Undergoing Hemodialysis: A Randomized Clinical Trial. J Acupunct Meridian Stud. 2020 Aug;13(4):117-123. doi: 10.1016/j.jams.2020.05.002. Epub 2020 Jun 1.

    PubMed 32497714
  • Yan CN, Yao WG, Bao YJ, Shi XJ, Yu H, Yin PH, Liu GZ. Effect of Auricular Acupressure on Uremic Pruritus in Patients Receiving Hemodialysis Treatment: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2015;2015:593196. doi: 10.1155/2015/593196. Epub 2015 Oct 1.

    PubMed 26495017

Questions about this trial

What is this clinical trial studying?

A study testing Acupressure in people with Hemodialysis and Uremic Pruritus, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

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 4 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: finished, as of the sponsor's last update on 23 Mar 2023. 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 Taiwan. 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?

Pittsburgh Sleep Quality Index (time frame: Pre-test). The study lists 12 primary outcomes in all. 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 NCT05575193, which also lists 6 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 23 Mar 2023.

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