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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06028685
Other study ID # 2022-06-002B
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 12, 2022
Est. completion date February 21, 2023

Study information

Verified date August 2023
Source Taipei Veterans General Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date February 21, 2023
Est. primary completion date December 20, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
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