Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Uremic Pruritus
• Intervention / Treatment: Other: Acupressure

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Peitou
    • Taipei, Peitou, Taiwan, 11219
      • Xuan-Yi Huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Skin-related disease
2. Liver disease
3. Psychiatric disorder
4. Cancer undergoing chemotherapy or radiation therapy
5. Nerve or vascular or soft tissue diseases of the extremitie
6. Infections or surgeries on the extremitie

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupressure Group; The 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.	Other: Acupressure; 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.
No Intervention: Non-Acupressure Group; Acupressure 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-test
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.	Post-test at week 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.	Post-test at week 8
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.	Post-test at week 12
Visual analogue scale	Is a subjective feeling, no itching = 0, very intense itching = 10, mainly to assess the intensity of the itching	Pre-test
Visual analogue scale	Is a subjective feeling, no itching = 0, very intense itching = 10, mainly to assess the intensity of the itching	Post-test at week 4
Visual analogue scale	Is a subjective feeling, no itching = 0, very intense itching = 10, mainly to assess the intensity of the itching	Post-test at week 8
Visual analogue scale	Is a subjective feeling, no itching = 0, very intense itching = 10, mainly to assess the intensity of the itching	Post-test at week 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)	Pre-test
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)	Post-test at week 4
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)	Post-test at week 8
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)	Post-test at week 12

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Investigators: Principal Investigator: Xuan-Yi Huang, DNSc, National Taipei University of Nursing and Health Sciences

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Sleep Quality; Effect; Acupressure; Hemodialysis; Uremic Pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: 202102EM001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No