Auricular Acupressure for Hemodialysis Patients With Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2019-05-01

Brief Summary

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Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. A randomized controlled clinical trial is planned to evaluate the effect and safety of AAT in MHD patients with insomnia.

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Detailed Description

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Insomnia, a worldwide health problem, is much more frequently complained in maintenance hemodialysis (MHD) patients and impairs their quality of life and long term outcome. Hypnotic sedative agents are often reluctantly prescribed with doses mounting up. Patients are concerned about drug dependence and drug-related adverse effects. As a non-drug therapy, auricular acupressure therapy (AAT) is attractive to both patients and practitioners and is widely used to treat many conditions in China. The investigators had been applying AAT for MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. Therefore, the investigators aimed to perform a randomized controlled clinical trial in MHD patients with insomnia to evaluate the effect and safety of AAT.

Conditions

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Insomnia Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Auricular acupressure therapy

Participants in the treatment group will received AAT on five active acupoints including Acup.1. Shen Men (Spiritual Gate, TF4), Acup.2. Jiao Gan (Sympathetic autonomic, AH6a), Acup.3. Xin (Heart, CO15), Acup.4. Pi Zhi Xia (Subcortex, AT4), Acup.5. Nei Fen Mi (Endocrine, CO18)

Group Type EXPERIMENTAL

auricular acupressure therapy

Intervention Type OTHER

Auricular acupressure, is a therapeutic method in which specific acupoints on the ear are stimulated to treat various disorders of the body. This practice is based on the theory that there are specific points on the auricle which correspond to major organs or systems of the body; and therapeutic effect on the corresponding target organ or system can be exerted by manipulating auricular acupoints. Auricular acupressure applies stimulation through pressure on specific acupoints by the imbedded beads, usually Semen Vaccaria (Wang Bu Liu Xing) or stainless steel beads. This therapeutic method is non-invasive and can be self-manipulated by the recipients at times required.

sham auricular acupressure therapy

Participants in the control group (SAA group) will receive auricular acupressure on five Helix points (HX 5-9), which were clearly remote from the inner ear area. These points have no evidence for insomnia management.

Group Type SHAM_COMPARATOR

sham auricular acupressure therapy

Intervention Type OTHER

The intervention is the same as that in the experimental group only when the points are five Helix points (HX 5-9). These points are clearly remote from the inner ear area and have no evidence for insomnia treatment.

Interventions

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auricular acupressure therapy

Auricular acupressure, is a therapeutic method in which specific acupoints on the ear are stimulated to treat various disorders of the body. This practice is based on the theory that there are specific points on the auricle which correspond to major organs or systems of the body; and therapeutic effect on the corresponding target organ or system can be exerted by manipulating auricular acupoints. Auricular acupressure applies stimulation through pressure on specific acupoints by the imbedded beads, usually Semen Vaccaria (Wang Bu Liu Xing) or stainless steel beads. This therapeutic method is non-invasive and can be self-manipulated by the recipients at times required.

Intervention Type OTHER

sham auricular acupressure therapy

The intervention is the same as that in the experimental group only when the points are five Helix points (HX 5-9). These points are clearly remote from the inner ear area and have no evidence for insomnia treatment.

Intervention Type OTHER

Other Intervention Names

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auricular acupressure ear acupressure sham AAT

Eligibility Criteria

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Inclusion Criteria

* Aged 18\~75 years
* On regular dialysis ( 2 - 3 sessions weekly, 4 hours each session, total weekly dialysis hours ≥ 10 hours) for more than 3 months (but less than 10 years)
* Insomnia according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Global score of PSQI \> 7
* Informed consent.

Exclusion Criteria

* Presence of co-morbidities including cancer, congestive heart failure, connective tissue disease and hematologic diseases;
* Inadequately dialyzed, indicating by urea clearance index (KT/V) \< 1.20;
* Presence of severe physical symptoms such as bone pain, itchy skin, sleep apnea and restless legs which are obviously causative for insomnia; and weary condition caused by severe anemia (hemoglobin\<60g/L) or malnutrition (serum albumin\<30g/L).
* Infections of external ears or malformed ears.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No