Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis

Study Overview
=================
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.

Official Title
-----------------
The Effect of Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis

Conditions
-----------------
Hemodialysis, Uremic Pruritus

Intervention / Treatment
-----------------
* Other: Acupressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupressure Group<br>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<br>* 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.<br>|
| No Intervention: Non-Acupressure Group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Acupressure, Uremic Pruritus, Sleep Quality, Effect