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The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center

Primary Purpose

Schizophrenia, Constipation

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Auricular acupressure
health education
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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:

    1. 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.
    2. Objective symptoms: Type 1 or 2 of Bristol Stool Form assessment.
    3. Long-term use(1 month and above) of laxatives such as MgO、Sennoside etc ., or need to use an enema to defecate.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

experimental group I(auricular acupressure and usual care)

experimental group II(usual care and auricular acupressure)

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

Patient Assessment of Constipation Symptoms questionnaire
Patient Assessment of Constipation Symptoms
Patient Assessment of Constipation Symptoms questionnaire
Patient Assessment of Constipation Symptoms
Bristol Stool Scale
frequency of defecation, range of 1-7 and low score indicate constipation
Bristol Stool Scale
frequency of defecation, range of 1-7 and low score indicate constipation
Bristol Stool Scale
frequency of defecation, range of 1-7 and low score indicate constipation
heart rate variability.
heart rate variability.
heart rate variability.
heart rate variability.
heart rate variability.
heart rate variability.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2022
Last Updated
April 20, 2023
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05517460
Brief Title
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
Official Title
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Constipation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group I(auricular acupressure and usual care)
Arm Type
Experimental
Arm Description
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.
Arm Title
experimental group II(usual care and auricular acupressure)
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
Auricular acupressure
Intervention Description
The participant in Intervention period will receive acupressure on ear Shenmen point, ear Large intestine point, ear Rectumn point and ear San Jiao point.
Intervention Type
Other
Intervention Name(s)
health education
Intervention Description
health education for self-care and medication adherence
Primary Outcome Measure Information:
Title
Patient Assessment of Constipation Symptoms questionnaire
Description
Patient Assessment of Constipation Symptoms
Time Frame
Baseline
Title
Patient Assessment of Constipation Symptoms questionnaire
Description
Patient Assessment of Constipation Symptoms
Time Frame
at eight weeks after intervention
Title
Bristol Stool Scale
Description
frequency of defecation, range of 1-7 and low score indicate constipation
Time Frame
Baseline
Title
Bristol Stool Scale
Description
frequency of defecation, range of 1-7 and low score indicate constipation
Time Frame
at four weeks after intervention
Title
Bristol Stool Scale
Description
frequency of defecation, range of 1-7 and low score indicate constipation
Time Frame
at eight weeks after intervention
Title
heart rate variability.
Description
heart rate variability.
Time Frame
Baseline
Title
heart rate variability.
Description
heart rate variability.
Time Frame
at four weeks after intervention
Title
heart rate variability.
Description
heart rate variability.
Time Frame
at eight weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Huang, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei county
ZIP/Postal Code
110301
Country
Taiwan

12. IPD Sharing Statement

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The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center

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