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

Primary Purpose

Salivary Gland Diseases

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
True auricular acupuncture
sham auricular acupuncture
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Salivary Gland Diseases

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Yilan Yuanshan Hopsital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

True auricular acupuncture

Sham auricular acupuncture

Arm Description

Effective auricular acupuncture

Ineffective auricular acupuncture

Outcomes

Primary Outcome Measures

Subjective dry mouth health
self-rated salivation
Objective dry mouth health
Salivation measured by Oral moisture meter

Secondary Outcome Measures

Full Information

First Posted
July 26, 2020
Last Updated
April 25, 2022
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04507646
Brief Title
The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population
Official Title
The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
September 2, 2020 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Gland Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
True auricular acupuncture
Arm Type
Experimental
Arm Description
Effective auricular acupuncture
Arm Title
Sham auricular acupuncture
Arm Type
Sham Comparator
Arm Description
Ineffective auricular acupuncture
Intervention Type
Other
Intervention Name(s)
True auricular acupuncture
Intervention Description
The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.
Intervention Type
Other
Intervention Name(s)
sham auricular acupuncture
Intervention Description
The participant in control group will receive acupuncture on ineffective point at ear.
Primary Outcome Measure Information:
Title
Subjective dry mouth health
Description
self-rated salivation
Time Frame
pre-test and post-test
Title
Objective dry mouth health
Description
Salivation measured by Oral moisture meter
Time Frame
pre-test and post-test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Residents in long-term institutions aged over 65 years old Living in long-term institutions at least six months and above Having normal cognitive functions with Mini-Mental State Examination scores more than 25 scores. Exclusion Criteria: The resident whose acupuncture point has Trauma, eczema or ulcer. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Huang, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yilan Yuanshan Hopsital
City
Yilan City
ZIP/Postal Code
26443
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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