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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517460
• Other study ID #: 202204021
• Status: Completed
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: April 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Schizophrenia

Intervention

Other:
• 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.
• health education
health education for self-care and medication adherence

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei county

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Assessment of Constipation Symptoms questionnaire	Patient Assessment of Constipation Symptoms	Baseline
Primary	Patient Assessment of Constipation Symptoms questionnaire	Patient Assessment of Constipation Symptoms	at eight weeks after intervention
Primary	Bristol Stool Scale	frequency of defecation, range of 1-7 and low score indicate constipation	Baseline
Primary	Bristol Stool Scale	frequency of defecation, range of 1-7 and low score indicate constipation	at four weeks after intervention
Primary	Bristol Stool Scale	frequency of defecation, range of 1-7 and low score indicate constipation	at eight weeks after intervention
Primary	heart rate variability.	heart rate variability.	Baseline
Primary	heart rate variability.	heart rate variability.	at four weeks after intervention
Primary	heart rate variability.	heart rate variability.	at eight weeks after intervention