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

NCT ID: NCT05517460

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2023-03-15

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.

Conditions

Schizophrenia; Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

experimental group I(auricular acupressure and usual care)

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.

Group Type: EXPERIMENTAL

Auricular acupressure

Intervention Type: OTHER

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 education

Intervention Type: OTHER

health education for self-care and medication adherence

experimental group II(usual care and auricular acupressure)

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 .

Group Type: EXPERIMENTAL

Auricular acupressure

Intervention Type: OTHER

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 education

Intervention Type: OTHER

health education for self-care and medication adherence

Interventions

Auricular acupressure

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

health education

health education for self-care and medication adherence

Intervention Type: OTHER

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:

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Huang, Hui-Chuan

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui-Chuan Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei County, , Taiwan

Countries

Taiwan

Other Identifiers

202204021

Identifier Type: -

Identifier Source: org_study_id