Conditions:Effectiveness of Auricular Acupressure on the Methadone PatientNCT05913830
Effectiveness of Auricular Acupressure on the Methadone Patient
A study testing Auricular pressure in people with Conditions:Effectiveness of Auricular Acupressure on the Methadone Patient, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
This study aims to investigate the effect of auricular point sticking on constipation in patients with methadone Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditions:Effectiveness of Auricular Acupressure on the Methadone Patient
- What is being tested?
- Auricular pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- People with blood coagulation problems and related diseases, such as: purpura, hemophilia, etc.
- Age <20 years old.
- Subjects who use drugs to improve constipation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the effect of auricular point sticking on constipation in patients with methadone
Read the 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.
- Being tested
- Auricular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular pressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: | Experimental | Experimental Group A total of 36 methadone patients will receive auricular pressure Receives: Other: Auricular pressure |
| Control group: | No intervention | Control group 36 bits No interventions implemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions:Effectiveness of Auricular Acupressure on the Methadone PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei City Hospital
- Responsible party
- Principal investigator, Ya-Fang Lin, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913830
- Sponsor's protocol ID
- TCHIRB-11012011
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Auricular Acupressure on the Methadone Patient
- ClinicalTrials.gov ID
- NCT05913830
- Acronym / sponsor ID
- TCHIRB-11012011
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Taipei City Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effect of auricular point sticking on constipation in patients with methadone
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: | Experimental | Other: Auricular pressureExperimental Group A total of 36 methadone patients will receive auricular pressure |
| Control group: | No intervention | –Control group 36 bits No interventions implemented |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular pressureThe 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. | Other | Experimental group: |
Primary outcome
The effect of constipation after auricular acupressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular pressure in people with Conditions:Effectiveness of Auricular Acupressure on the Methadone Patient, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of constipation after auricular acupressure (time frame: six weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.