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

Sponsor
Taipei Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04507646
Collaborator
(none)
124
1
2
8.1
15.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: True auricular acupuncture
  • Other: sham auricular acupuncture
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes 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.
Primary Purpose:
Supportive Care
Official Title:
The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population
Actual Study Start Date :
Aug 26, 2020
Actual Primary Completion Date :
Sep 2, 2020
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: True auricular acupuncture

Effective auricular acupuncture

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

Sham Comparator: Sham auricular acupuncture

Ineffective auricular acupuncture

Other: sham auricular acupuncture
The participant in control group will receive acupuncture on ineffective point at ear.

Outcome Measures

Primary Outcome Measures

  1. Subjective dry mouth health [pre-test and post-test]

    self-rated salivation

  2. Objective dry mouth health [pre-test and post-test]

    Salivation measured by Oral moisture meter

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yilan Yuanshan Hopsital Yilan City Taiwan 26443

Sponsors and Collaborators

  • Taipei Medical University

Investigators

  • Principal Investigator: Hui-Chuan Huang, PhD, Taipei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huang, Hui-Chuan, The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population, Taipei Medical University
ClinicalTrials.gov Identifier:
NCT04507646
Other Study ID Numbers:
  • N202001048
First Posted:
Aug 11, 2020
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022