Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

Hemodialysis Clinical Trial

Official title:

Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06028685
• Other study ID #: 2022-06-002B
• Status: Completed
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: February 21, 2023

Study information

• Verified date: August 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney disease. However, long-term dialysis can lead to fatigue and decreased sleep quality. Acupoint stimulation can regulate meridians and improve physical function. Nevertheless, the effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis patients remains unclear.

This study is designed to use low-level laser stimulation as an intervention measure to evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients.

Description:

Hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney disease. However, long-term dialysis can lead to fatigue and decreased sleep quality. Acupoint stimulation can regulate meridians and improve physical function. Nevertheless, the effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis patients remains unclear.

This study is designed to use low-level laser stimulation as an intervention measure to evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients.

The experimental group will receive low-level laser stimulation on seven acupoints, including Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao (SP6), and Taixi (KI3). The stimulation will be administered three times per week for a duration of six weeks. The control group will receive sham low-level laser stimulation on the acupoints, without emitting laser beams.

Before and after each intervention, fatigue will be measured using a visual analog scale for a total of 18 measurements. Additionally, at baseline and at the 2nd, 4th, and 6th weeks, the hemodialysis patients will be assessed using the Fatigue Scale for Hemodialysis Patients, Dialysis Recovery Time Scale, Pittsburgh Sleep Quality Index, Dialysis Symptom Index, and Beck Depression Inventory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 21, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Adults aged 20 years and above.

2. Diagnosed with end-stage kidney disease and receiving regular outpatient hemodialysis three times a week for at least three months.

3. Conscious and capable of communication in Mandarin or Taiwanese (Hokkien).

4. Willing to participate in this study and have signed the informed consent form.

Exclusion Criteria:

1. Presence of skin lesions or infectious wounds at the acupoint locations.

2. Taking immunosuppressive medication.

3. Photosensitivity or sensitivity to light.

4. Individuals with implanted cardiac pacemakers.

5. Patients using sleep medication.

Related Conditions & MeSH terms

• Fatigue
• Hemodialysis

Intervention

Device:
• Acupoint stimulation
The experimental group will receive low-level laser stimulation on seven acupoints, including Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao (SP6), and Taixi (KI3). The stimulation will be administered three times per week for a duration of six weeks.
• Acupoint stimulation(placebo)
The control group will receive sham low-level laser stimulation on seven acupoints, including Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao (SP6), and Taixi (KI3), without emitting laser beams.The stimulation will be administered three times per week for a duration of six weeks.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue1	The fatigue visual analogue scale:The score ranges from 0 to 10 points, with higher scores indicating a higher level of fatigue.	Three times per week, for six weeks, totaling 18 sessions.
Primary	fatigue2	Fatigue Scale for Hemodialysis Patients:The score ranges from 26 to 104 points, with higher scores indicating a higher level of fatigue.	measured at baseline and at the 2nd, 4th, and 6th weeks.
Primary	fatigue3	Dialysis recovery time: The recovery time is divided into four intervals, including less than 2 hours, 2-6 hours, 7-12 hours, and greater than 12 hours. This is determined by responses from dialysis patients regarding the time needed for recovery during dialysis treatment.	measured at baseline and at the 2nd, 4th, and 6th weeks.
Primary	sleep	Pittsburgh Sleep Quality Index:The total score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality.	measured at baseline and at the 2nd, 4th, and 6th weeks.