Effectiveness of Auricular Acupressure on the Methadone Patient

Sponsor

National Taipei University of Nursing and Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05913830

Collaborator

Taipei City Hospital (Other)

Enrollment

Location

Arms

14.9

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to investigate the effect of auricular point sticking on constipation in patients with methadone

Condition or Disease	Intervention/Treatment	Phase
Conditions:Effectiveness of Auricular Acupressure on the Methadone Patient	Other: Auricular pressure	N/A

Detailed Description

This study is a randomized controlled trial, taking 72 methadone constipation patients from a hospital in the north as objects, and divided them into an auricular point group and a control group. The experimental group was given auricular point sticking, while the control group only used sticking cloth. The two groups were measured for constipation, TCM constitution, anxiety, depression and quality of life before the intervention and 2 weeks, 4 weeks, and 6 weeks after the start.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

Effectiveness of Auricular Acupressure on the Methadone Patient

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group: Experimental Group A total of 36 methadone patients will receive auricular pressure	Other: Auricular pressure The seeds of blancia blanc were fixed on the acupoints with patches. The intervention measure in the experimental group was auricular point sticking. The two groups received four measurements before the intervention and 2 weeks, 4 weeks, and 6 weeks after the start; while the control group received no Auricular pressure.
No Intervention: Control group: Control group 36 bits No interventions implemented

Arm

Intervention/Treatment

Experimental: Experimental group:

Experimental Group A total of 36 methadone patients will receive auricular pressure

Other: Auricular pressure

The seeds of blancia blanc were fixed on the acupoints with patches. The intervention measure in the experimental group was auricular point sticking. The two groups received four measurements before the intervention and 2 weeks, 4 weeks, and 6 weeks after the start; while the control group received no Auricular pressure.

No Intervention: Control group:

Control group 36 bits No interventions implemented

Outcome Measures

Primary Outcome Measures

The effect of constipation after auricular acupressure [six weeks]
There were significant between-group differences in Bristol Stool Type at Weeks 2, 4, and 6 between the two groups (p= .003, p < .001, p < .001, respectively). The distribution of Bristol Stool Types in the second week, the fourth week, and the sixth week of the above-mentioned auricular point sticking intervention in the two groups all had statistically significant differences.
The effect of TCM constitution after the intervention of auricular acupressure [six weeks]
The total score of the experimental group in the 2nd week and the 6th week was damp and hot (p < .05); the experimental group had a significant difference in the decrease of the total score of the qi stagnation in the 4th week and the 6th week (p < .05).
The effect of intervention on depression and anxiety after auricular acupressure [six weeks]
There was no significant difference in the scores of the Bayesian Anxiety Scale and depression between the experimental group and the control group at the 2nd week, 4th week and 6th week (p > .05).
Effect of Interventional Auricular Acupressure on Quality of Life for Constipation [six weeks]
There were significant differences in the decrease of the total score of the experimental group in the 2nd week, 4th week and 6th week (p < .05, p < .001, p < .001 respectively)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Methadone patients over 20 years old.
Those who have clear consciousness and can communicate in Chinese and Taiwanese.
The frequency of defecation is less than three times a week.
Willing to sign a written subject consent form.

Exclusions:

Those with wounds, broken skin, and blisters on the skin of both ears.
People with blood coagulation problems and related diseases, such as: purpura, hemophilia, etc.
Age <20 years old.
Subjects who use drugs to improve constipation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ya-Fang Lin	Taipei		Taiwan	108

Sponsors and Collaborators

National Taipei University of Nursing and Health Sciences
Taipei City Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ya-Fang Lin, National Taipei University of Nursing and Health Sciences, National Taipei University of Nursing and Health Sciences

ClinicalTrials.gov Identifier:

NCT05913830

Other Study ID Numbers:

TCHIRB-11012011

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 22, 2023