Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-12

Study Completion Date

2023-02-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study adopts an experimental research design.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Acupoint stimulation

Intervention Type DEVICE

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.

control group

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

Group Type PLACEBO_COMPARATOR

Acupoint stimulation(placebo)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No