Clinical trial NCT05575193: Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis
Official title: The Effect of Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Uremic Pruritus
Keywords: Hemodialysis
Acupressure
Uremic Pruritus
Sleep Quality
Effect
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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".
Primary purpose: TREATMENT

Brief 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. The patients receiving the intervention of acupressure are in the experimental group, while those who do not receive it are in the control group.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Pre-test
measure: Pittsburgh Sleep Quality Index
timeFrame: Post-test at week 4
measure: Pittsburgh Sleep Quality Index
timeFrame: Post-test at week 8
measure: Pittsburgh Sleep Quality Index
timeFrame: Post-test at week 12
measure: Visual analogue scale
timeFrame: Pre-test
measure: Visual analogue scale
timeFrame: Post-test at week 4
measure: Visual analogue scale
timeFrame: Post-test at week 8
measure: Visual analogue scale
timeFrame: Post-test at week 12
measure: 5D Pruritus Scale
timeFrame: Pre-test
measure: 5D Pruritus Scale
timeFrame: Post-test at week 4
measure: 5D Pruritus Scale
timeFrame: Post-test at week 8
measure: 5D Pruritus Scale
timeFrame: Post-test at week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Xuan-Yi Huang
state: Peitou
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Xuan-Yi Huang, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.