Effectiveness of Auricular Acupressure on the Methadone Patient

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

Study Overview

• Status: Completed
• Conditions: Conditions:Effectiveness of Auricular Acupressure on the Methadone Patient
• Intervention / Treatment: Other: Auricular pressure

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 108
    • Ya-Fang Lin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusions:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of constipation after auricular acupressure	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.	six weeks
The effect of TCM constitution after the intervention of auricular acupressure	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).	six weeks
The effect of intervention on depression and anxiety after auricular acupressure	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).	six weeks
Effect of Interventional Auricular Acupressure on Quality of Life for Constipation	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)	six weeks

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Collaborators: Taipei City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TCHIRB-11012011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No