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Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

Primary Purpose

Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupoint stimulation
Acupoint stimulation(placebo)
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemodialysis focused on measuring fatigue, sleep

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults aged 20 years and above. Diagnosed with end-stage kidney disease and receiving regular outpatient hemodialysis three times a week for at least three months. Conscious and capable of communication in Mandarin or Taiwanese (Hokkien). Willing to participate in this study and have signed the informed consent form. Exclusion Criteria: Presence of skin lesions or infectious wounds at the acupoint locations. Taking immunosuppressive medication. Photosensitivity or sensitivity to light. Individuals with implanted cardiac pacemakers. Patients using sleep medication.

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

experimental group

control group

Arm Description

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.

The control group will receive sham low-level laser stimulation on the acupoints, without emitting laser beams.

Outcomes

Primary Outcome Measures

fatigue1
The fatigue visual analogue scale:The score ranges from 0 to 10 points, with higher scores indicating a higher level of fatigue.
fatigue2
Fatigue Scale for Hemodialysis Patients:The score ranges from 26 to 104 points, with higher scores indicating a higher level of fatigue.
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.
sleep
Pittsburgh Sleep Quality Index:The total score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2023
Last Updated
August 31, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT06028685
Brief Title
Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis
Official Title
Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
February 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis
Keywords
fatigue, sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study adopts an experimental research design.
Masking
ParticipantOutcomes Assessor
Masking Description
This study employs computer-based random allocation, where the assignments are sealed in opaque envelopes. The researchers open the envelopes to distribute participants into the experimental and control groups, ensuring blinding of the study participants. The data analysts responsible for statistical analysis are separate individuals who are unaware of the participants' grouping.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The control group will receive sham low-level laser stimulation on the acupoints, without emitting laser beams.
Intervention Type
Device
Intervention Name(s)
Acupoint stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Acupoint stimulation(placebo)
Intervention Description
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.
Primary Outcome Measure Information:
Title
fatigue1
Description
The fatigue visual analogue scale:The score ranges from 0 to 10 points, with higher scores indicating a higher level of fatigue.
Time Frame
Three times per week, for six weeks, totaling 18 sessions.
Title
fatigue2
Description
Fatigue Scale for Hemodialysis Patients:The score ranges from 26 to 104 points, with higher scores indicating a higher level of fatigue.
Time Frame
measured at baseline and at the 2nd, 4th, and 6th weeks.
Title
fatigue3
Description
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.
Time Frame
measured at baseline and at the 2nd, 4th, and 6th weeks.
Title
sleep
Description
Pittsburgh Sleep Quality Index:The total score ranges from 0 to 21 points, with higher scores indicating poorer sleep quality.
Time Frame
measured at baseline and at the 2nd, 4th, and 6th weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 20 years and above. Diagnosed with end-stage kidney disease and receiving regular outpatient hemodialysis three times a week for at least three months. Conscious and capable of communication in Mandarin or Taiwanese (Hokkien). Willing to participate in this study and have signed the informed consent form. Exclusion Criteria: Presence of skin lesions or infectious wounds at the acupoint locations. Taking immunosuppressive medication. Photosensitivity or sensitivity to light. Individuals with implanted cardiac pacemakers. Patients using sleep medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rou-Yu Sung
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

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Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

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