The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population

NCT ID: NCT04507646

Last Updated: 2022-04-27

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

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2021-04-30

Brief Summary

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The study aims to examine the effect of auricular acupuncture on improving oral health in older population. The hypothesis of this study is that older people receiving auricular acupuncture can increase salivary secretion. By identifying the effectiveness of auricular acupuncture can increase salivary secretion; suitable care can be suggested to improve oral health in older population living in long-term institutions.

Detailed Description

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The elderly living in long-term institutions are mostly limited to physical dysfunction and highly dependence. In addition, the chronic diseases are affected by taking a variety of drugs, which may easily lead to dry mouth. Thus, providing oral health to increase secretion of saliva is high recommended to those older population. The study is used to examine the effect of auricular acupuncture on improving oral health in older population. The eligible participants are random assign to experimental group receiving auricular acupuncture and control group having ineffective auricular acupuncture. Outcome measures include demographic variables, general health status and secretion of saliva, such as: Subjective dry mouth condition and objective mouth condition. Generalized linear model will be used to examine the effect of auricular acupuncture on improving oral health. By identifying the effectiveness of auricular acupuncture can increase salivary secretion; suitable care can be suggested to improve oral health in older population living in long-term institutions.

Conditions

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Salivary Gland Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Two blinded researchers indenpendent performered auricular acupuncture for experimental or control group, respectively.

Experimental group receive true auricular acupuncture and control group receive sham auricular acupuncture.

Study Groups

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True auricular acupuncture

Effective auricular acupuncture

Group Type EXPERIMENTAL

True auricular acupuncture

Intervention Type OTHER

The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.

Sham auricular acupuncture

Ineffective auricular acupuncture

Group Type SHAM_COMPARATOR

sham auricular acupuncture

Intervention Type OTHER

The participant in control group will receive acupuncture on ineffective point at ear.

Interventions

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True auricular acupuncture

The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.

Intervention Type OTHER

sham auricular acupuncture

The participant in control group will receive acupuncture on ineffective point at ear.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Residents in long-term institutions aged over 65 years old
2. Living in long-term institutions at least six months and above
3. Having normal cognitive functions with Mini-Mental State Examination scores more than 25 scores.

Exclusion Criteria

1. The resident whose acupuncture point has Trauma, eczema or ulcer.
2. Incapable of salivary secretion caused by disease,sush as radiation-induced xerostomia among patients with nasopharyngeal carcinoma, Sjogren's Syndrome,acute sialadenitis,chronic recurrent sialadenitis,viral salivary gland infection,salivary gland stones.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Huang, Hui-Chuan

The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hui-Chuan Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

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Yilan Yuanshan Hopsital

Yilan, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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N202001048

Identifier Type: -

Identifier Source: org_study_id

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