Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

August 31, 2023 updated by: Taipei Veterans General Hospital, Taiwan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: experimental group
The experimental group will receive low-level laser stimulation on seven acupoints. The stimulation will be administered three times per week for a duration of six weeks.
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.
Placebo Comparator: control group
The control group will receive sham low-level laser stimulation on the acupoints, without emitting laser beams.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatigue1
Time Frame: Three times per week, for six weeks, totaling 18 sessions.
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.
fatigue2
Time Frame: measured at baseline and at the 2nd, 4th, and 6th weeks.
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.
fatigue3
Time Frame: measured at baseline and at the 2nd, 4th, and 6th weeks.
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.
sleep
Time Frame: measured at baseline and at the 2nd, 4th, and 6th weeks.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Rou-Yu Sung, Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2022

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

February 21, 2023

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-06-002B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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