Clinical trial NCT06028685: Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis
Official title: Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: fatigue
sleep
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-09-08
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study adopts an experimental research design.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: fatigue1
timeFrame: Three times per week, for six weeks, totaling 18 sessions.
measure: fatigue2
timeFrame: measured at baseline and at the 2nd, 4th, and 6th weeks.
measure: fatigue3
timeFrame: measured at baseline and at the 2nd, 4th, and 6th weeks.
measure: sleep
timeFrame: measured at baseline and at the 2nd, 4th, and 6th weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Rou-Yu Sung
role: PRINCIPAL_INVESTIGATOR
References: