SchizophreniaNCT05517460
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
A study testing Auricular acupressure and health education in people with Schizophrenia and Constipation, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The purpose of the study is to examine the effect of auricular acupressure on improvement of constipation and heart rate variability among residents with schizophrenia in community rehabilitation Center.The hypothesis of this study is that residents with schizophrenia in Community Rehabilitation Center receiving… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Constipation
- What is being tested?
- Auricular acupressure and health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Sep 2022to 15 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living in community rehabilitation center for at least six months and above.
- Community rehabilitation center residents aged 40 and over.
- Clinical diagnosis of Schizophrenia.
- Having constipation-related symptoms: meet at least one of the following conditions:
- Chief complaint of discomfort of defecation such as difficulty in defecation, hard stool, straining during defecation, feeling of incomplete defecation, feeling of obstructed defecation, defecation frequency less than three times a week.
- Objective symptoms: Type 1 or 2 of Bristol Stool Form assessment.
- Long-term use(1 month and above) of laxatives such as MgO、Sennoside etc ., or need to use an enema to defecate.
Who cannot join
- Incapable of complying with the direction and responding to questionnaires.
- Having wound or local skin lesion on acupressure point.
- Having organic constipation caused by abdominal operation in the past.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to examine the effect of auricular acupressure on improvement of constipation and heart rate variability among residents with schizophrenia in community rehabilitation Center.The hypothesis of this study is that residents with schizophrenia in Community Rehabilitation Center receiving auricular acupressure can improve the symptoms of constipation and heart rate variability.By identifying the effectiveness of auricular acupressure can reduce the occurrence of constipation; suitable care can be suggested to improve gastrointestinal health in residents of Schizophrenia in community rehabilitation center.
Read the detailed description
Due to the use of psychiatric medication and the impairment of cognition lead to poor lifestyle which is result in constipation among the residents of community rehabilitation center.In addition, the residents affected by psychosis and poor cognition are hard to pay attention and implement on the non-pharmacological interventions completely with complicated process.Therefore, contriving a simple intervention, which may improve constipation and constipation-related symptoms. The purpose of this study is to examine the effectiveness of applying auricular acupressure for relieving the constipation symptoms of residents of Schizophrenia in community rehabilitation center. A cross-over study design is used for this study. The eligible participants were random assign to experimental group I or experimental group II. Experimental group I received 8 weeks of auricular acupressure then 8 weeks of routine health care of constipation. Experimental group II received same interventions in reverse order (8 weeks of routine health care of constipation then 8 weeks of auricular acupressure).In both groups, any interventions were stopped for two month as residual effect wash-out period after 8 weeks intervention. Outcome measures include demographic variables, general health status and defecation condition. Subjective defecation condition is related to self-perceived constipation measured by the Patient Assessment of Constipation Symptoms scale. Objective defecation condition includes frequency of defecation, the grade of Bristol Stool Scale and heart rate variability. Mean, standard deviation, frequency, percentage, t-test and chi-square test will be used to analyze the data. In addition, generalized estimating equations will be used to examine the effect of auricular acupressure on improving constipation. By identifying the effectiveness of auricular acupressure can reduce the occurrence of constipation; suitable care can be suggested to improve gastrointestinal health in residents of Schizophrenia in community rehabilitation center.
- Conditions
- Schizophrenia, Constipation
- Being tested
- Auricular acupressure, health education
- Medical subject headings
- Schizophrenia, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressureOther
The participant in Intervention period will receive acupressure on ear Shenmen point, ear Large intestine point, ear Rectumn point and ear San Jiao point.
health educationOther
health education for self-care and medication adherence
| Study group | Role | What they receive |
|---|---|---|
| experimental group I(auricular acupressure and usual care) | Experimental | Experimental group I receives 8 weeks of auricular acupressure first, then interventions are stopped for two month as residual effect wash-out period. And after that Experimental group I receives 8 weeks of routine health care of constipation. Receives: Other: Auricular acupressure; Other: health education |
| experimental group II(usual care and auricular acupressure) | Experimental | Experimental group II receives 8 weeks of routine health care of constipation first, then interventions are stopped for two month as residual effect wash-out period. And after that Experimental group II receives 8 weeks of auricular acupressure . Receives: Other: Auricular acupressure; Other: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Assessment of Constipation Symptoms questionnaire
Patient Assessment of Constipation Symptoms
Measured: Baseline
Patient Assessment of Constipation Symptoms questionnaire
Patient Assessment of Constipation Symptoms
Measured: at eight weeks after intervention
Bristol Stool Scale
frequency of defecation, range of 1-7 and low score indicate constipation
Measured: Baseline
Bristol Stool Scale
frequency of defecation, range of 1-7 and low score indicate constipation
Measured: at four weeks after intervention
Bristol Stool Scale
frequency of defecation, range of 1-7 and low score indicate constipation
Measured: at eight weeks after intervention
heart rate variability.
heart rate variability.
Measured: Baseline
heart rate variability.
heart rate variability.
Measured: at four weeks after intervention
heart rate variability.
heart rate variability.
Measured: at eight weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start6 Sep 2022
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang, Hui-Chuan, Taipei Medical University
- Investigators
- Hui-Chuan Huang, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517460
- Sponsor's protocol ID
- 202204021
- Status last verified
- Apr 2023
- First submitted
- 19 Aug 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
- ClinicalTrials.gov ID
- NCT05517460
- Acronym / sponsor ID
- 202204021
- Conditions
- Schizophrenia, Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 26 Aug 2022 (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.
The purpose of the study is to examine the effect of auricular acupressure on improvement of constipation and heart rate variability among residents with schizophrenia in community rehabilitation Center.The hypothesis of this study is that residents with schizophrenia in Community Rehabilitation Center receiving auricular acupressure can improve the symptoms of constipation and heart rate variability.By identifying the effectiveness of auricular acupressure can reduce the occurrence of constipation; suitable care can be suggested to improve gastrointestinal health in residents of Schizophrenia in community rehabilitation center.
Detailed description
Due to the use of psychiatric medication and the impairment of cognition lead to poor lifestyle which is result in constipation among the residents of community rehabilitation center.In addition, the residents affected by psychosis and poor cognition are hard to pay attention and implement on the non-pharmacological interventions completely with complicated process.Therefore, contriving a simple intervention, which may improve constipation and constipation-related symptoms. The purpose of this study is to examine the effectiveness of applying auricular acupressure for relieving the constipation symptoms of residents of Schizophrenia in community rehabilitation center. A cross-over study design is used for this study. The eligible participants were random assign to experimental group I or experimental group II. Experimental group I received 8 weeks of auricular acupressure then 8 weeks of routine health care of constipation. Experimental group II received same interventions in reverse order (8 weeks of routine health care of constipation then 8 weeks of auricular acupressure).In both groups, any interventions were stopped for two month as residual effect wash-out period after 8 weeks intervention. Outcome measures include demographic variables, general health status and defecation condition. Subjective defecation condition is related to self-perceived constipation measured by the Patient Assessment of Constipation Symptoms scale. Objective defecation condition includes frequency of defecation, the grade of Bristol Stool Scale and heart rate variability. Mean, standard deviation, frequency, percentage, t-test and chi-square test will be used to analyze the data. In addition, generalized estimating equations will be used to examine the effect of auricular acupressure on improving constipation. By identifying the effectiveness of auricular acupressure can reduce the occurrence of constipation; suitable care can be suggested to improve gastrointestinal health in residents of Schizophrenia in community rehabilitation center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group I(auricular acupressure and usual care) | Experimental | Other: Auricular acupressure, Other: health educationExperimental group I receives 8 weeks of auricular acupressure first, then interventions are stopped for two month as residual effect wash-out period. And after that Experimental group I receives 8 weeks of routine health care of constipation. |
| experimental group II(usual care and auricular acupressure) | Experimental | Other: Auricular acupressure, Other: health educationExperimental group II receives 8 weeks of routine health care of constipation first, then interventions are stopped for two month as residual effect wash-out period. And after that Experimental group II receives 8 weeks of auricular acupressure . |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Living in community rehabilitation center for at least six months and above.
- Community rehabilitation center residents aged 40 and over.
- Clinical diagnosis of Schizophrenia.
- Having constipation-related symptoms: meet at least one of the following conditions:
Key exclusion criteria (3 listed)
- Incapable of complying with the direction and responding to questionnaires.
- Having wound or local skin lesion on acupressure point.
- Having organic constipation caused by abdominal operation in the past.
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 acupressureThe participant in Intervention period will receive acupressure on ear Shenmen point, ear Large intestine point, ear Rectumn point and ear San Jiao point. | Other | experimental group I(auricular acupressure and usual care), experimental group II(usual care and auricular acupressure) |
| health educationhealth education for self-care and medication adherence | Other | experimental group I(auricular acupressure and usual care), experimental group II(usual care and auricular acupressure) |
Primary outcome
Patient Assessment of Constipation Symptoms questionnaire
Time frame: Baseline
Patient Assessment of Constipation Symptoms
Patient Assessment of Constipation Symptoms questionnaire
Time frame: at eight weeks after intervention
Patient Assessment of Constipation Symptoms
Bristol Stool Scale
Time frame: Baseline
frequency of defecation, range of 1-7 and low score indicate constipation
Bristol Stool Scale
Time frame: at four weeks after intervention
frequency of defecation, range of 1-7 and low score indicate constipation
Bristol Stool Scale
Time frame: at eight weeks after intervention
frequency of defecation, range of 1-7 and low score indicate constipation
heart rate variability.
Time frame: Baseline
heart rate variability.
heart rate variability.
Time frame: at four weeks after intervention
heart rate variability.
heart rate variability.
Time frame: at eight weeks after intervention
heart rate variability.
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 21 Apr 2023.
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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.
Hui-Chuan Huang, PhD principal investigator
Taipei Medical University
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 acupressure and health education in people with Schizophrenia and Constipation, run by Taipei Medical University 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 7 inclusion and 3 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 21 Apr 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?
Patient Assessment of Constipation Symptoms questionnaire (time frame: Baseline). The study lists 8 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 21 Apr 2023.