Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Completed
• CT.gov ID: NCT06028685
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 11.4

Study Details

Study Description

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)	N/A

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

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study adopts an experimental research design.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: Aug 12, 2022
• Actual Primary Completion Date: Dec 20, 2022
• Actual Study Completion Date: Feb 21, 2023

Arms and Interventions

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

Primary Outcome Measures

1. fatigue1 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan	11217

Sponsors and Collaborators

• Taipei Veterans General Hospital, Taiwan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taipei Veterans General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT06028685
• Other Study ID Numbers: 2022-06-002B
• First Posted: Sep 8, 2023
• Last Update Posted: Sep 8, 2023
• Last Verified: Aug 1, 2023

• 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: Fatigue

Study Results

No Results Posted as of Sep 8, 2023