Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

NCT06028685 | Completed

• 1 other identifier: 2022-06-002B
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis

Keywords

fatigue; sleep

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

experimental group

ACTIVE COMPARATOR

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

control group

PLACEBO COMPARATOR

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

Device: Acupoint stimulation(placebo)

Interventions

Acupoint stimulation 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.

experimental group

Acupoint stimulation(placebo) 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.

control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Publications (1)

• Sung RY, Yeh ML, Chen FP, Lo MY, Yu J. Laser acupuncture improves post-dialysis fatigue and sleep quality independent of time-varying dialysis and depression symptoms: a double-blind, randomized, placebo-controlled trial. BMC Complement Med Ther. 2025 Dec 13. doi: 10.1186/s12906-025-05203-3. Online ahead of print.

  PMID: 41390393 DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rou-Yu Sung

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study adopts an experimental research design.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: September 8, 2023
• Study Start: August 12, 2022
• Primary Completion: December 20, 2022
• Study Completion: February 21, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-08

Locations

TW (1)