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Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

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ClinicalTrials.gov Identifier: NCT06028685
Recruitment Status : Completed
First Posted : September 8, 2023
Last Update Posted : September 8, 2023
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hemodialysis Device: Acupoint stimulation Device: Acupoint stimulation(placebo) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study adopts an experimental research design.
Masking: Double (Participant, 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.
Primary Purpose: Supportive Care
Official Title: Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis
Actual Study Start Date : August 12, 2022
Actual Primary Completion Date : December 20, 2022
Actual Study Completion Date : February 21, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06028685


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Rou-Yu Sung Taipei Veterans General Hospital, Taiwan
More Information
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT06028685    
Other Study ID Numbers: 2022-06-002B
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
fatigue
sleep
Additional relevant MeSH terms:
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Fatigue