Clinical trial NCT05517460: The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
Official title: The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Constipation
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Patient Assessment of Constipation Symptoms questionnaire
timeFrame: Baseline
measure: Patient Assessment of Constipation Symptoms questionnaire
timeFrame: at eight weeks after intervention
measure: Bristol Stool Scale
timeFrame: Baseline
measure: Bristol Stool Scale
timeFrame: at four weeks after intervention
measure: Bristol Stool Scale
timeFrame: at eight weeks after intervention
measure: heart rate variability.
timeFrame: Baseline
measure: heart rate variability.
timeFrame: at four weeks after intervention
measure: heart rate variability.
timeFrame: at eight weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Hui-Chuan Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: