<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/NCT03003091</url>
  </required_header>
  <id_info>
    <org_study_id>Chulabhorn</org_study_id>
    <nct_id>NCT03003091</nct_id>
  </id_info>
  <brief_title>Needs-Based Patient Education Versus Traditional Patient Education in Reducing Pre-operative Anxiety in Day Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulabhorn Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulabhorn Hospital</source>
  <brief_summary>
    <textblock>
      In patient education, the amount of information that is not proper with the individual&#xD;
      patient, such as too much or too little, can increase anxiety to patient. Needs-based patient&#xD;
      education has been developed to determine the proper amount of information and provide the&#xD;
      education based on patient needs. This study aims to compare needs-based patient education to&#xD;
      traditional patient education in how they affect preoperative anxiety and patient&#xD;
      satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preoperative anxiety can compromise surgical outcome. Anxiety increases serum cortisol,&#xD;
      adrenaline, and noradrenaline. This results in postoperative pain, increased postoperative&#xD;
      analgesic requirements, prolonged hospital stay and patient dissatisfaction. However, this&#xD;
      anxiety can be reduced.&#xD;
&#xD;
      Patient education has been widely used to reduce operative anxiety; however, some patients&#xD;
      have more anxiety after patient education. This incident could be explained by different&#xD;
      individual's coping styles that patients use to deal with their anxiety. There are four major&#xD;
      coping style: vigilant, avoidant, fluctuating, and flexible. Vigilant coper desires extended&#xD;
      information to reduce anxiety. Avoidant coper desires minimal amount of information as too&#xD;
      much will cause anxiety. Fluctuating coper generally desires small amount of information but&#xD;
      desires greater detail in certain area. Flexible coper is able to adapt to whatever&#xD;
      information available. Thus, if patient education with extended information is given to&#xD;
      patients with avoidant coping style, they will have more anxiety. One study found that&#xD;
      avoidant coping style is 31% of surgical patients in the study population. This is also&#xD;
      supported by another study that one-third of patients reported to be worried after receiving&#xD;
      an informative booklet. Therefore, to be able to deal with all types of coping style, patient&#xD;
      education with different levels of information regarding patient needs is proposed to be&#xD;
      developed.&#xD;
&#xD;
      Needs-based patient education has become more promising with increased supporting literature.&#xD;
      It uses the principle of shared decision making, which is the pinnacle of patient-centered&#xD;
      care. Needs-based patient education is also consistent with adult learning theory, which&#xD;
      learning should be matched with different individual background and needs. A randomized&#xD;
      controlled trial was conducted to compare needs-based patient education with traditional&#xD;
      patient education in rheumatoid arthritis and found a superior result. However, there is&#xD;
      still lack of evidence in using needs-based patient education in surgery.&#xD;
&#xD;
      This study evaluates needs-based patient education in reducing preoperative anxiety. To&#xD;
      assess patient needs, a questionnaire is used as a tool. After receiving completed&#xD;
      questionnaire, the physician provides information based on patient needs. Not only patients&#xD;
      will benefit from this questionnaire but also physicians. The questionnaire enables physician&#xD;
      to cut unnecessary information and pay more attention to the fact that patients need. Less&#xD;
      information needed is less time spent in patient education session. As the most important&#xD;
      reason why patient education is omitted is shortness of time. This needs-based patient&#xD;
      education can contribute tremendously to the way we educate surgical patients.&#xD;
&#xD;
      Objectives This study aims to compare needs-based patient education to traditional patient&#xD;
      education in how they affect preoperative anxiety, patient satisfaction, and time&#xD;
      consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient anxiety before patient education (STAI)</measure>
    <time_frame>1 day</time_frame>
    <description>Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient anxiety before patient education (VAS)</measure>
    <time_frame>1 day</time_frame>
    <description>Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient anxiety after patient education (STAI)</measure>
    <time_frame>1 day</time_frame>
    <description>Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient anxiety after patient education (VAS)</measure>
    <time_frame>1 day</time_frame>
    <description>Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient anxiety after operation (STAI)</measure>
    <time_frame>1 day</time_frame>
    <description>Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient anxiety after operation (VAS)</measure>
    <time_frame>1 day</time_frame>
    <description>Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction before patient education</measure>
    <time_frame>1 day</time_frame>
    <description>Patient satisfaction was measured by a 100 mm visual analogue scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction after patient education</measure>
    <time_frame>1 day</time_frame>
    <description>Patient satisfaction was measured by a 100 mm visual analogue scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction after surgery</measure>
    <time_frame>1 day</time_frame>
    <description>Patient satisfaction was measured by a 100 mm visual analogue scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Education time</measure>
    <time_frame>1 day</time_frame>
    <description>Time in patient education was recorded with stopwatch at the beginning to the end of patient education session</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">470</enrollment>
  <condition>Educational Problems</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Needs-based patient education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants received self-administered questionnaire to choose what topics they wanted to know and how much information they would like to know. After completing the questionnaire, the participants submit the questionnaire to their physicians (investigators). The surgeon then provided patient education based on participant needs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional patient education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants received all structured information</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Needs-based patient education</intervention_name>
    <arm_group_label>Needs-based patient education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional patient education</intervention_name>
    <arm_group_label>Traditional patient education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  scheduled for day surgery&#xD;
&#xD;
          -  willing to cooperate with the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  illegibility which could not answer questionnaire by themselves&#xD;
&#xD;
          -  psychiatric diseases&#xD;
&#xD;
          -  undergoing previous surgery within 6 months&#xD;
&#xD;
          -  possibility to undergo major operation after day surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>January 8, 2017</last_update_submitted>
  <last_update_submitted_qc>January 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulabhorn Hospital</investigator_affiliation>
    <investigator_full_name>Apinut Wongkietkachorn</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03003091
org study id: Chulabhorn
nct id: NCT03003091
lead sponsor: 
In patient education, the amount of information that is not proper with the individual
      patient, such as too much or too little, can increase anxiety to patient. Needs-based patient
      education has been developed to determine the proper amount of information and provide the
      education based on patient needs. This study aims to compare needs-based patient education to
      traditional patient education in how they affect preoperative anxiety and patient
      satisfaction.
Preoperative anxiety can compromise surgical outcome. Anxiety increases serum cortisol,
      adrenaline, and noradrenaline. This results in postoperative pain, increased postoperative
      analgesic requirements, prolonged hospital stay and patient dissatisfaction. However, this
      anxiety can be reduced.

      Patient education has been widely used to reduce operative anxiety; however, some patients
      have more anxiety after patient education. This incident could be explained by different
      individual's coping styles that patients use to deal with their anxiety. There are four major
      coping style: vigilant, avoidant, fluctuating, and flexible. Vigilant coper desires extended
      information to reduce anxiety. Avoidant coper desires minimal amount of information as too
      much will cause anxiety. Fluctuating coper generally desires small amount of information but
      desires greater detail in certain area. Flexible coper is able to adapt to whatever
      information available. Thus, if patient education with extended information is given to
      patients with avoidant coping style, they will have more anxiety. One study found that
      avoidant coping style is 31% of surgical patients in the study population. This is also
      supported by another study that one-third of patients reported to be worried after receiving
      an informative booklet. Therefore, to be able to deal with all types of coping style, patient
      education with different levels of information regarding patient needs is proposed to be
      developed.

      Needs-based patient education has become more promising with increased supporting literature.
      It uses the principle of shared decision making, which is the pinnacle of patient-centered
      care. Needs-based patient education is also consistent with adult learning theory, which
      learning should be matched with different individual background and needs. A randomized
      controlled trial was conducted to compare needs-based patient education with traditional
      patient education in rheumatoid arthritis and found a superior result. However, there is
      still lack of evidence in using needs-based patient education in surgery.

      This study evaluates needs-based patient education in reducing preoperative anxiety. To
      assess patient needs, a questionnaire is used as a tool. After receiving completed
      questionnaire, the physician provides information based on patient needs. Not only patients
      will benefit from this questionnaire but also physicians. The questionnaire enables physician
      to cut unnecessary information and pay more attention to the fact that patients need. Less
      information needed is less time spent in patient education session. As the most important
      reason why patient education is omitted is shortness of time. This needs-based patient
      education can contribute tremendously to the way we educate surgical patients.

      Objectives This study aims to compare needs-based patient education to traditional patient
      education in how they affect preoperative anxiety, patient satisfaction, and time
      consumption.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Patient anxiety before patient education (STAI)
time frame: 1 day
description: Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
measure: Patient anxiety before patient education (VAS)
time frame: 1 day
description: Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
measure: Patient anxiety after patient education (STAI)
time frame: 1 day
description: Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
measure: Patient anxiety after patient education (VAS)
time frame: 1 day
description: Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
measure: Patient anxiety after operation (STAI)
time frame: 1 day
description: Patient anxiety was assessed with Spielberger state-trait anxiety inventory (STAI)
measure: Patient anxiety after operation (VAS)
time frame: 1 day
description: Patient anxiety was assessed with a 100 mm visual analogue scale for anxiety (VAS-anxiety)
measure: Patient Satisfaction before patient education
time frame: 1 day
description: Patient satisfaction was measured by a 100 mm visual analogue scale.
measure: Patient Satisfaction after patient education
time frame: 1 day
description: Patient satisfaction was measured by a 100 mm visual analogue scale.
measure: Patient Satisfaction after surgery
time frame: 1 day
description: Patient satisfaction was measured by a 100 mm visual analogue scale.
measure: Education time
time frame: 1 day
description: Time in patient education was recorded with stopwatch at the beginning to the end of patient education session
arm group label: Needs-based patient education
arm group type: Experimental
description: The participants received self-administered questionnaire to choose what topics they wanted to know and how much information they would like to know. After completing the questionnaire, the participants submit the questionnaire to their physicians (investigators). The surgeon then provided patient education based on participant needs.
arm group label: Traditional patient education
arm group type: Active Comparator
description: The participants received all structured information
intervention type: Other
intervention name: Needs-based patient education
arm group label: Needs-based patient education
intervention type: Other
intervention name: Traditional patient education
arm group label: Traditional patient education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Chulabhorn Hospital
investigator full name: Apinut Wongkietkachorn
investigator title: Doctor