Skip to main content
OpenTrials
Completed

NCT Number: NCT05517460

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei County, 110301, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Health education

Other

health education for self-care and medication adherence

Primary outcomes

  1. Patient Assessment of Constipation Symptoms questionnaire

    Time frame: Baseline

    Patient Assessment of Constipation Symptoms

  2. Patient Assessment of Constipation Symptoms questionnaire

    Time frame: at eight weeks after intervention

    Patient Assessment of Constipation Symptoms

  3. Bristol Stool Scale

    Time frame: Baseline

    frequency of defecation, range of 1-7 and low score indicate constipation

  4. Bristol Stool Scale

    Time frame: at four weeks after intervention

    frequency of defecation, range of 1-7 and low score indicate constipation

  5. Bristol Stool Scale

    Time frame: at eight weeks after intervention

    frequency of defecation, range of 1-7 and low score indicate constipation

  6. heart rate variability.

    Time frame: Baseline

    heart rate variability.

  7. heart rate variability.

    Time frame: at four weeks after intervention

    heart rate variability.

  8. heart rate variability.

    Time frame: at eight weeks after intervention

    heart rate variability.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.