NCT05913830

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

May 29, 2023

Last Update Submit

June 13, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Experimental group:

EXPERIMENTAL

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

Other: Auricular pressure

Control group:

NO INTERVENTION

Control group 36 bits No interventions implemented

Interventions

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.

Experimental group:

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ya-Fang Lin

Taipei, 108, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Taipei University of Nursing and Health Sciences

Study Record Dates

First Submitted

May 29, 2023

First Posted

June 22, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations