Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

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

Tracking Information

• First Submitted Date: July 31, 2023
• First Posted Date: September 8, 2023
• Last Update Posted Date: September 8, 2023
• Actual Study Start Date: August 12, 2022
• Actual Primary Completion Date: December 20, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2023)

• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Hemodialysis

Intervention

• 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.
• 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.

Study Arms

• 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.
  Intervention: Device: Acupoint stimulation
• Placebo Comparator: control group
  The control group will receive sham low-level laser stimulation on the acupoints, without emitting laser beams.
  Intervention: Device: Acupoint stimulation(placebo)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 31, 2023): 72
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 21, 2023
• Actual Primary Completion Date: December 20, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT06028685
• Other Study ID Numbers: 2022-06-002B
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Taipei Veterans General Hospital, Taiwan
• Original Responsible Party: Same as current
• Current Study Sponsor: Taipei Veterans General Hospital, Taiwan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rou-Yu Sung; Taipei Veterans General Hospital, Taiwan

• PRS Account: Taipei Veterans General Hospital, Taiwan
• Verification Date: August 2023