<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/NCT04494087</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01548</org_study_id>
    <nct_id>NCT04494087</nct_id>
  </id_info>
  <brief_title>The Effect of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty on Information Providing: a Multicenter Randomized Controlled Trial</brief_title>
  <official_title>Potential Benefit in Information Providing and Influence on Patient Anxiety and Satisfaction by Means of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty: a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kantonsspital Winterthur KSW</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Winterthur KSW</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of electronic media in informed consent giving has become increasingly important in&#xD;
      recent years. Due to the easy access to information via electronical media, patients are&#xD;
      primed in a heterogeneous manner concerning expectations and wishes regarding surgical&#xD;
      interventions. Inherent to its nature elective interventions are critically questioned as&#xD;
      there is time for information gathering and reflection.&#xD;
&#xD;
      In this study, the investigators set out to investigate the effect of an educational video as&#xD;
      a supporting element in the process of informed consent giving for one the most frequently&#xD;
      performed interventions in general surgery, namely inguinal hernia repair.&#xD;
&#xD;
      In a multi-center setup, eligible patients for primary inguinal hernia repair will be&#xD;
      randomly assigned to 1 of 3 groups. The intervention video provides basic principles of&#xD;
      endoscopic extraperitoneal hernia repair. The second video is similar in length and design&#xD;
      and displays general aspects of day surgery in the two study centres. The third group's link&#xD;
      will lead to the digital version of the informed consent. Primary outcomes will consist of 1)&#xD;
      score in a multiple choice test assessing gain of knowledge regarding hernia repair, 2)&#xD;
      difference in the State-Trait Anxiety Inventory (STAI) and 3) patient satisfaction&#xD;
      questionnaire (ICF, Picker Institute, Germany) as assessed 1-2 days after the first&#xD;
      consultation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 18, 2022</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score in multiple-choice-test</measure>
    <time_frame>assessed 1-2 days after group allocation/exposure</time_frame>
    <description>Quiz with questions regarding background, indication, implementation, complications and postoperative course of the total extraperitoneal inguinal h ernioplasty (TEP) procedure. The questions asked check relevant aspects for the patient with regard to the planned operation. The structure of the multiple-choice quiz takes the &quot;single best option&quot; out of 12 questions. Maximum value of the test is 12 (12/12, highest score-best outcome), the lowest 0 (0/12, lowest score-worst outcome).&#xD;
The questions are clearly posed and the correct answer is based on current guidelines for the management of inguinal hernia, which have been published by the European Hernia Society (EHS), American Hernia Society (AHS), International Endo Hernia Society (IEHS) and the European Association for Endoscopic Surgery and Other Interventional Techniques (EAES) as a consensus document by &quot;HerniaSurge&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spielberg State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>assessed 1-2 days after group allocation/exposure</time_frame>
    <description>To test the effect of the intervention on anxiety before surgery, an anxiety score is determined using the Spielberg State-Trait Anxiety Inventory (STAI).&#xD;
The inventory is based on a 4-point Likert scale and consists of 40 questions on a self-report basis.&#xD;
Scores range from 20 to 80 with higher scores indicating greater anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual Clinician Feedback (ICF)</measure>
    <time_frame>assessed 30 days postoperatively at follow-up visit</time_frame>
    <description>Patient satisfaction with regard to doctor-patient communication is recorded by the validated ICF questionnaire.&#xD;
The ICF questionnaire (Picker Institute) comprises 38 items concerning the patient's experience of the examination atmosphere, the comprehensibility of the physician's statements, the participation in decisions, the course of the conversation as well as socio-demographic characteristics of the patient. The items are assessed on an 11-point Likert scale from 0 to 10, with 0 as the most critical and 10 as the most positive experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical rating scale (NRS)</measure>
    <time_frame>assessed 3 months postoperatively</time_frame>
    <description>To assess the effect on chronic pain, the pain is assessed by telephone using the NRS score approximately 3 months after the operation.&#xD;
The numerical rating scale (NRS) requires the patient to rate his or her pain on a scale from 0 to 10, in which 0 is no pain (best outcome) and 10 the worst pain imaginable (worst outcome).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">183</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Hernia video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The video of the intervention group will provide a short (&lt; 5 min) summary explaining the basic principles of endoscopic extraperitoneal hernia repair, its possible complications and the postoperative course. After carefully watching the video, participants should be able to correctly answer to a multiple-choice test consisting of 12 questions related to the aforementioned topics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mock video</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This video is a general documentation of the &quot;typical&quot; day of surgery in the day clinic. The information is essentially limited to the pictorial representation of the individual wards which the patient will pass through during the operation (arrival at the clinic, admission, transport to the operating theatre, recovery room, discharge).&#xD;
The video explicitly does not transport any information that could be helpful for answering the quiz questions or for medical understanding of the operation itself.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The link of the third group leads to a digital version of the information sheet, which has already been discussed with all patients during the informed consent discussion. The digital version of the informed consent form allows the patient to read the information again. The third group thus corresponds to the standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Explanatory video</intervention_name>
    <description>Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving</description>
    <arm_group_label>Hernia video</arm_group_label>
    <arm_group_label>Mock video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Informed consent form</intervention_name>
    <description>Links to a digital version of the informed consent form already discussed during the process of informed consent giving.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral or bilateral hernia with indication for surgical therapy&#xD;
&#xD;
          -  signed informed consent form for trial participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had surgery for ipsi- or contralateral inguinal or femoral hernia&#xD;
&#xD;
          -  combination interventions (umbilical and inguinal hernia repair, e.g.)&#xD;
&#xD;
          -  cognitive, audio-visual or linguistic handicap raising concern of complete&#xD;
             understanding of the research project&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Gingert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cantonal Hospital Winterthur, Department of Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fabian Lunger, MD,PhD</last_name>
    <phone>+41 052 266 21 21</phone>
    <email>fabian.lunger@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>GZO Spital Wetzikon</name>
      <address>
        <city>Wetzikon</city>
        <zip>8620</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cantonal Hospital Winterthur, Department of Surgery</name>
      <address>
        <city>Winterthur</city>
        <zip>8400</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>inguinal hernia</keyword>
  <keyword>informed consent</keyword>
  <keyword>STAI</keyword>
  <keyword>ICF</keyword>
  <keyword>State-Trait Anxiety Inventory</keyword>
  <keyword>Individual Clinician Feedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share individual participant data (IPD) with other researchers.</ipd_description>
  </patient_data>
  <!-- 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/NCT04494087
org study id: 2020-01548
nct id: NCT04494087
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of electronic media in informed consent giving has become increasingly important in
      recent years. Due to the easy access to information via electronical media, patients are
      primed in a heterogeneous manner concerning expectations and wishes regarding surgical
      interventions. Inherent to its nature elective interventions are critically questioned as
      there is time for information gathering and reflection.

      In this study, the investigators set out to investigate the effect of an educational video as
      a supporting element in the process of informed consent giving for one the most frequently
      performed interventions in general surgery, namely inguinal hernia repair.

      In a multi-center setup, eligible patients for primary inguinal hernia repair will be
      randomly assigned to 1 of 3 groups. The intervention video provides basic principles of
      endoscopic extraperitoneal hernia repair. The second video is similar in length and design
      and displays general aspects of day surgery in the two study centres. The third group's link
      will lead to the digital version of the informed consent. Primary outcomes will consist of 1)
      score in a multiple choice test assessing gain of knowledge regarding hernia repair, 2)
      difference in the State-Trait Anxiety Inventory (STAI) and 3) patient satisfaction
      questionnaire (ICF, Picker Institute, Germany) as assessed 1-2 days after the first
      consultation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Score in multiple-choice-test
time frame: assessed 1-2 days after group allocation/exposure
description: Quiz with questions regarding background, indication, implementation, complications and postoperative course of the total extraperitoneal inguinal h ernioplasty (TEP) procedure. The questions asked check relevant aspects for the patient with regard to the planned operation. The structure of the multiple-choice quiz takes the "single best option" out of 12 questions. Maximum value of the test is 12 (12/12, highest score-best outcome), the lowest 0 (0/12, lowest score-worst outcome).
The questions are clearly posed and the correct answer is based on current guidelines for the management of inguinal hernia, which have been published by the European Hernia Society (EHS), American Hernia Society (AHS), International Endo Hernia Society (IEHS) and the European Association for Endoscopic Surgery and Other Interventional Techniques (EAES) as a consensus document by "HerniaSurge".
measure: Spielberg State-Trait Anxiety Inventory (STAI)
time frame: assessed 1-2 days after group allocation/exposure
description: To test the effect of the intervention on anxiety before surgery, an anxiety score is determined using the Spielberg State-Trait Anxiety Inventory (STAI).
The inventory is based on a 4-point Likert scale and consists of 40 questions on a self-report basis.
Scores range from 20 to 80 with higher scores indicating greater anxiety.
measure: Individual Clinician Feedback (ICF)
time frame: assessed 30 days postoperatively at follow-up visit
description: Patient satisfaction with regard to doctor-patient communication is recorded by the validated ICF questionnaire.
The ICF questionnaire (Picker Institute) comprises 38 items concerning the patient's experience of the examination atmosphere, the comprehensibility of the physician's statements, the participation in decisions, the course of the conversation as well as socio-demographic characteristics of the patient. The items are assessed on an 11-point Likert scale from 0 to 10, with 0 as the most critical and 10 as the most positive experience.
measure: Numerical rating scale (NRS)
time frame: assessed 3 months postoperatively
description: To assess the effect on chronic pain, the pain is assessed by telephone using the NRS score approximately 3 months after the operation.
The numerical rating scale (NRS) requires the patient to rate his or her pain on a scale from 0 to 10, in which 0 is no pain (best outcome) and 10 the worst pain imaginable (worst outcome).
arm group label: Hernia video
arm group type: Active Comparator
description: The video of the intervention group will provide a short (< 5 min) summary explaining the basic principles of endoscopic extraperitoneal hernia repair, its possible complications and the postoperative course. After carefully watching the video, participants should be able to correctly answer to a multiple-choice test consisting of 12 questions related to the aforementioned topics.
arm group label: Mock video
arm group type: Placebo Comparator
description: This video is a general documentation of the "typical" day of surgery in the day clinic. The information is essentially limited to the pictorial representation of the individual wards which the patient will pass through during the operation (arrival at the clinic, admission, transport to the operating theatre, recovery room, discharge).
The video explicitly does not transport any information that could be helpful for answering the quiz questions or for medical understanding of the operation itself.
arm group label: Control group
arm group type: Sham Comparator
description: The link of the third group leads to a digital version of the information sheet, which has already been discussed with all patients during the informed consent discussion. The digital version of the informed consent form allows the patient to read the information again. The third group thus corresponds to the standard of care.
intervention type: Other
intervention name: Explanatory video
description: Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving
arm group label: Hernia video
arm group label: Mock video
intervention type: Other
intervention name: Informed consent form
description: Links to a digital version of the informed consent form already discussed during the process of informed consent giving.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Gingert, MD
role: Principal Investigator
affiliation: Cantonal Hospital Winterthur, Department of Surgery
last name: Fabian Lunger, MD,PhD
phone: +41 052 266 21 21
email: fabian.lunger@gmail.com
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Switzerland
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: No
ipd description: There is no plan to share individual participant data (IPD) with other researchers.