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

NCT05517460 | Completed

• 1 other identifier: 202204021
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Constipation

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

Study Arms (2)

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.

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 .

Other: Auricular acupressure; Other: health education

Interventions

Auricular acupressure 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.

experimental group I(auricular acupressure and usual care); experimental group II(usual care and auricular acupressure)

health education OTHER

health education for self-care and medication adherence

experimental group I(auricular acupressure and usual care); experimental group II(usual care and auricular acupressure)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei County, 110301, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Constipation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui-Chuan Huang, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Efficacy of Auricular Acupressure on Improving Constipation among Residents in Community Rehabilitation Center

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 26, 2022
• Study Start: September 6, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

TW (1)