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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Constipation
• Intervention / Treatment: Other: Auricular acupressure; Other: health education

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei county, Taiwan, 110301
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other: health education; health education for self-care and medication adherence
Experimental: 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 .	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.; Other: health education; health education for self-care and medication adherence

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Constipation
• Other Study ID Numbers: 202204021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No