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Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06028685
Enrollment
72
Registered
2023-09-08
Start date
2022-08-12
Completion date
2023-02-21
Last updated
2023-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

Keywords

fatigue, sleep

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.

Interventions

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.

DEVICEAcupoint 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.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes 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.

Intervention model description

This study adopts an experimental research design.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
fatigue3measured 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.
fatigue1Three 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.
fatigue2measured 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.
sleepmeasured 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026