<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02187640</url>
  </required_header>
  <id_info>
    <org_study_id>hkpusn01</org_study_id>
    <nct_id>NCT02187640</nct_id>
  </id_info>
  <brief_title>Effects of Self-administered Acupressure in Psychiatric Patients With Constipation</brief_title>
  <official_title>A Randomised Controlled Trial of Self-administered Acupressure in Adult Psychiatric Patients With Constipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the effects of self-administered acupressure therapy for&#xD;
      psychiatric in-patients with constipation&#xD;
&#xD;
      Two main research questions include:&#xD;
&#xD;
        1. What are the effects of the standardized self-administered acupressure program on&#xD;
           reducing those adult psychiatric patients' symptoms of constipation?&#xD;
&#xD;
        2. What are the psychiatric patients' (participants') perceived benefits and limitations of&#xD;
           self-administered acupressure on management of their constipation?&#xD;
&#xD;
      In this study, the participants who met the study criteria and completed the baseline&#xD;
      measurement would be randomly assigned into either the self-administered acupressure program,&#xD;
      or a sham control group who receive a placebo, non-acupoint pressure. The null hypotheses of&#xD;
      this study are:&#xD;
&#xD;
        1. There is no significant difference between the acupressure and sham group immediately&#xD;
           and/or two weeks after the completion of intervention on patients' symptom severity of&#xD;
           constipation; and&#xD;
&#xD;
        2. There is no significant difference between the acupressure and sham group on patients'&#xD;
           perceived quality of life at immediately and two weeks after treatment completion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main outcomes of this study include the Constipation Assessment Scale (CAS), Patient&#xD;
      Assessment Constipation Quality of Life Questionnaire (PAC-QoL), and the socio-demographic&#xD;
      and clinical data collected by a trained assessor who was blind to the intervention&#xD;
      assignment of the participants. These data would be measured at recruitment (baseline) and&#xD;
      immediately (Post-test 1) and two weeks (Post-test 2) after completion of the 10-day&#xD;
      intervention. Qualitative focus group interview data would be collected after Post-test 2 .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Constipation Assessment Scale</measure>
    <time_frame>Baseline (0 week; before start of intervention)</time_frame>
    <description>The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Constipation Assessment Scale</measure>
    <time_frame>Fifth weeks (i.e., immediately after completion of the 10-day intervention)</time_frame>
    <description>The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Constipation Assessment Scale</measure>
    <time_frame>Seventh week (i.e., two weeks after completion of the intervention)</time_frame>
    <description>The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment Constipation Quality of Life Questionnaire</measure>
    <time_frame>Baseline (0 week; before start of intervention)</time_frame>
    <description>The Patient Assessment Constipation Quality of Life Questionnaire is a self-administered questionnaire for assessment of the magnitude and degree of interference associated with constipation symptomatology. The scale is composed of 28 items categorized into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Subjects rate each item on a 5-pont likert scale, ranging from '0 = none of the time or not at all to 4 = all of the time or extremely'. The overall and subscale scores can range from 0 to 4, with a lower total score indicating a better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment Constipation Quality of Life Questionnaire</measure>
    <time_frame>Fifth week (i.e., immediately after completion of the 10-day intervention)</time_frame>
    <description>The Patient Assessment Constipation Quality of Life Questionnaire is a self-administered questionnaire for assessment of the magnitude and degree of interference associated with constipation symptomatology. The scale is composed of 28 items categorized into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Subjects rate each item on a 5-pont likert scale, ranging from '0 = none of the time or not at all to 4 = all of the time or extremely'. The overall and subscale scores can range from 0 to 4, with a lower total score indicating a better health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Assessment Constipation Quality of Life Questionnaire</measure>
    <time_frame>Seventh week (i.e., two weeks after completion of the 10-day intervention)</time_frame>
    <description>The Patient Assessment Constipation Quality of Life Questionnaire is a self-administered questionnaire for assessment of the magnitude and degree of interference associated with constipation symptomatology. The scale is composed of 28 items categorized into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Subjects rate each item on a 5-pont likert scale, ranging from '0 = none of the time or not at all to 4 = all of the time or extremely'. The overall and subscale scores can range from 0 to 4, with a lower total score indicating a better health-related quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Self-administered acupressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 10-day self-administered acupressure program was implemented by the participants who were adult psychiatric in-patients and randomly assigned into this treatment group. The patients would receive a 3-session training of this therapy conducted by a qualified acupressure therapist and each session lasted about an hour. They would be assessed by the trainer to ensure that they are able to identify the five acupoints and applied a constant and an appropriate pressure on each acupoint before actual implementation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham control group: Patients would receive 3-session training and be assessed by the trainer. However, they would be trained to locate five non-acupoints adjacent to the actual acupoints and with minimal pressure applied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-administered acupressure</intervention_name>
    <description>Self-administered acupressure: In order to ensure the compliance of treatment, they would apply this intervention according to the acupressure group protocol once per day in groups with one trained research nurse's instructions and supervision .</description>
    <arm_group_label>Self-administered acupressure</arm_group_label>
    <other_name>Self-help acupressure therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sham control group</intervention_name>
    <description>Sham intervention: Patients received similar aupressure intervention on the non-acupoints.</description>
    <arm_group_label>Sham control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria of psychiatric in-patients are:&#xD;
&#xD;
          1. Hong Kong Chinese residents, aged 18 to 64 years;&#xD;
&#xD;
          2. satisfied with Rome III diagnostic criteria for constipation; and&#xD;
&#xD;
          3. mentally stable and competent for self-care and learning acupressure, as recommended&#xD;
             by their attending psychiatrists.&#xD;
&#xD;
        Exclusion criteria of those in-patients are:&#xD;
&#xD;
          1. anatomical and physiological disorders of gastrointestinal tract such as malrotation,&#xD;
             fistula and colonic neuropathies;&#xD;
&#xD;
          2. metabolic and endocrine diseases;&#xD;
&#xD;
          3. lead poisoning and vitamin D intoxication;&#xD;
&#xD;
          4. previous training in acupressure;&#xD;
&#xD;
          5. physical disability involved the upper limbs;&#xD;
&#xD;
          6. planned surgery undergoing during study period; and&#xD;
&#xD;
          7. pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wai Kit Wong, MN, DHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>One Regional Mental Hospital</name>
      <address>
        <city>Tuen Mun</city>
        <state>New Territories</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <results_reference>
    <citation>1. Wong, W.K., &amp; Chien, W.T. (2014). Evaluation the effect of Acupressure protocol on Adult psychiatric in-patients with constipation (Program book p. 55). The 35th International Association for Human Caring Conference - 'The Universality of Caring' (24 - 28 May 2014). Kyoto International Conference Center, Kyoto. Division of Family Health Care Nursing, Kobe University Graduate School of Health Sciences, Japan.</citation>
  </results_reference>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>August 17, 2015</last_update_submitted>
  <last_update_submitted_qc>August 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Chien Wai-Tong</investigator_full_name>
    <investigator_title>Professor and Associate Head</investigator_title>
  </responsible_party>
  <keyword>Acupressure</keyword>
  <keyword>Self-administration</keyword>
  <keyword>Psychiatric in-patients</keyword>
  <keyword>Constipation</keyword>
  <keyword>Self-administered acupressure program</keyword>
  <keyword>Sham control group</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02187640
org study id: hkpusn01
nct id: NCT02187640
lead sponsor: 
has dmc: Yes
This study is to evaluate the effects of self-administered acupressure therapy for
      psychiatric in-patients with constipation

      Two main research questions include:

        1. What are the effects of the standardized self-administered acupressure program on
           reducing those adult psychiatric patients' symptoms of constipation?

        2. What are the psychiatric patients' (participants') perceived benefits and limitations of
           self-administered acupressure on management of their constipation?

      In this study, the participants who met the study criteria and completed the baseline
      measurement would be randomly assigned into either the self-administered acupressure program,
      or a sham control group who receive a placebo, non-acupoint pressure. The null hypotheses of
      this study are:

        1. There is no significant difference between the acupressure and sham group immediately
           and/or two weeks after the completion of intervention on patients' symptom severity of
           constipation; and

        2. There is no significant difference between the acupressure and sham group on patients'
           perceived quality of life at immediately and two weeks after treatment completion.
Main outcomes of this study include the Constipation Assessment Scale (CAS), Patient
      Assessment Constipation Quality of Life Questionnaire (PAC-QoL), and the socio-demographic
      and clinical data collected by a trained assessor who was blind to the intervention
      assignment of the participants. These data would be measured at recruitment (baseline) and
      immediately (Post-test 1) and two weeks (Post-test 2) after completion of the 10-day
      intervention. Qualitative focus group interview data would be collected after Post-test 2 .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Constipation Assessment Scale
time frame: Baseline (0 week; before start of intervention)
description: The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.
measure: Constipation Assessment Scale
time frame: Fifth weeks (i.e., immediately after completion of the 10-day intervention)
description: The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.
measure: Constipation Assessment Scale
time frame: Seventh week (i.e., two weeks after completion of the intervention)
description: The 8-item Constipation Assessment Scale is an universal measurement tool for symptom severity of constipation in a wide variety of acute and chronic diseases and rated on a 3-point likert scale, ranging from '0= no problem', 1= some problem', and '2= severe problem'. A higher total score will indicate the more severe condition of one's constipation.
measure: Patient Assessment Constipation Quality of Life Questionnaire
time frame: Baseline (0 week; before start of intervention)
description: The Patient Assessment Constipation Quality of Life Questionnaire is a self-administered questionnaire for assessment of the magnitude and degree of interference associated with constipation symptomatology. The scale is composed of 28 items categorized into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Subjects rate each item on a 5-pont likert scale, ranging from '0 = none of the time or not at all to 4 = all of the time or extremely'. The overall and subscale scores can range from 0 to 4, with a lower total score indicating a better health-related quality of life.
measure: Patient Assessment Constipation Quality of Life Questionnaire
time frame: Fifth week (i.e., immediately after completion of the 10-day intervention)
description: The Patient Assessment Constipation Quality of Life Questionnaire is a self-administered questionnaire for assessment of the magnitude and degree of interference associated with constipation symptomatology. The scale is composed of 28 items categorized into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Subjects rate each item on a 5-pont likert scale, ranging from '0 = none of the time or not at all to 4 = all of the time or extremely'. The overall and subscale scores can range from 0 to 4, with a lower total score indicating a better health-related quality of life.
measure: Patient Assessment Constipation Quality of Life Questionnaire
time frame: Seventh week (i.e., two weeks after completion of the 10-day intervention)
description: The Patient Assessment Constipation Quality of Life Questionnaire is a self-administered questionnaire for assessment of the magnitude and degree of interference associated with constipation symptomatology. The scale is composed of 28 items categorized into four subscales, including dissatisfaction (5 items), physical discomfort (4 items), psychosocial discomfort (8 items), and worries and concerns (11 items). Subjects rate each item on a 5-pont likert scale, ranging from '0 = none of the time or not at all to 4 = all of the time or extremely'. The overall and subscale scores can range from 0 to 4, with a lower total score indicating a better health-related quality of life.
arm group label: Self-administered acupressure
arm group type: Experimental
description: A 10-day self-administered acupressure program was implemented by the participants who were adult psychiatric in-patients and randomly assigned into this treatment group. The patients would receive a 3-session training of this therapy conducted by a qualified acupressure therapist and each session lasted about an hour. They would be assessed by the trainer to ensure that they are able to identify the five acupoints and applied a constant and an appropriate pressure on each acupoint before actual implementation.
arm group label: Sham control group
arm group type: Sham Comparator
description: Sham control group: Patients would receive 3-session training and be assessed by the trainer. However, they would be trained to locate five non-acupoints adjacent to the actual acupoints and with minimal pressure applied.
intervention type: Behavioral
intervention name: Self-administered acupressure
description: Self-administered acupressure: In order to ensure the compliance of treatment, they would apply this intervention according to the acupressure group protocol once per day in groups with one trained research nurse's instructions and supervision .
arm group label: Self-administered acupressure
other name: Self-help acupressure therapy
intervention type: Behavioral
intervention name: Sham control group
description: Sham intervention: Patients received similar aupressure intervention on the non-acupoints.
arm group label: Sham control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Wai Kit Wong, MN, DHSc
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
facility: 
country: Hong Kong
citation: 1. Wong, W.K., & Chien, W.T. (2014). Evaluation the effect of Acupressure protocol on Adult psychiatric in-patients with constipation (Program book p. 55). The 35th International Association for Human Caring Conference - 'The Universality of Caring' (24 - 28 May 2014). Kyoto International Conference Center, Kyoto. Division of Family Health Care Nursing, Kobe University Graduate School of Health Sciences, Japan.
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Chien Wai-Tong
investigator title: Professor and Associate Head
mesh term: Constipation