<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/NCT03308071</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-41122</org_study_id>
    <nct_id>NCT03308071</nct_id>
  </id_info>
  <brief_title>Hypnosis for Symptom Management in Elective Orthopedic Surgery</brief_title>
  <official_title>A Randomized Study Using Hypnosis for Symptom Management in Elective Orthopedic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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 purpose of the study is to determine if teaching self-hypnosis techniques to patients&#xD;
      prior to knee replacement surgery will decrease their pain medication requirements, pain&#xD;
      medication side-effects, length of stay in the hospital, readmission rates, pain, anxiety,&#xD;
      physical function, satisfaction scores, and cost of admission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be recruited by through orthopedic surgery clinics or contacted by after&#xD;
      pre-screening via chart review and given an information brochure. If they are interested in&#xD;
      the trial will be emailed or given a paper copy of the consent form and scheduled for a&#xD;
      single additional visit in the Integrative Medicine Center at Hoover Pavilion approximately 1&#xD;
      week before surgery. At the single study visit, participants would be consented, then a&#xD;
      mini-mental state test would be performed to determine if participants are eligible by a&#xD;
      score of 25 or above. If eligible, participants would be asked to fill out surveys relating&#xD;
      to demographics, attitudes and experience with hypnosis, and detailed pain medication usage.&#xD;
      Then, participants would be randomized to hypnosis vs. no hypnosis. The hypnosis group will&#xD;
      undergo a Hypnotic Induction Profile to score hypnotizability, then be lead through a&#xD;
      hypnosis induction and read a perioperative symptom management script, then re-alerted from&#xD;
      hypnosis. Patients in this group would then be asked to listen to the same hypnosis script on&#xD;
      a telephone recording twice per day until after the surgery when participants feel they don't&#xD;
      need it anymore.&#xD;
&#xD;
      The control group will fill out the surveys and the study visit will end. Participants will&#xD;
      be asked not to use any hypnosis until the trial period is over. Data regarding pain,&#xD;
      activity, and satisfaction is already collected by email survey or by Ipad in orthopedic&#xD;
      clinic at or before the pre-op visit, and 3 months post-op.&#xD;
&#xD;
      Patients in the knee study will be asked to fill out the same surveys around the two week and&#xD;
      six week post-op orthopedic clinic visits as well. One additional survey will be added at the&#xD;
      2 week post-op visit to reassess attitudes and experience with hypnosis, and detailed pain&#xD;
      medication usage. Those participants who do not fill out the survey will be called and/or&#xD;
      emailed to remind them to fill it out.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</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>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>The treating team including surgeons, anesthesiologists, pain consultants, hospitalists who are in charge of administering pain medication and documenting outcomes will be blinded to the intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Narcotic use</measure>
    <time_frame>Index hospitalization for total knee replacement, average 2-3 days</time_frame>
    <description>Total narcotic use during the hospital stay will be calculated in &quot;morphine equivalents&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Narcotic prescriptions</measure>
    <time_frame>1 month before, and 3 months and 1 year after joint replacement</time_frame>
    <description>Total narcotics prescribed in the outpatient setting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Narcotic-associated side effects</measure>
    <time_frame>Index hospitalization for total knee replacement, average 2-3 days</time_frame>
    <description>Incidence of delirium, constipation, urinary retention, respiratory depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UCLA activity scores</measure>
    <time_frame>At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op</time_frame>
    <description>Classifies the activity level of joint replacement patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KOOS Jr Survey</measure>
    <time_frame>At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op</time_frame>
    <description>Knee injury and osteoarthritis outcome score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VR-12 Survey</measure>
    <time_frame>At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op</time_frame>
    <description>Measures health-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Society Score</measure>
    <time_frame>At the pre-op visit with the surgeon and 12 weeks post-op</time_frame>
    <description>Prosthesis function and patients' functional abilities after total knee arthroplasty (TKA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days hospitalized</measure>
    <time_frame>Reported once , after patient is discharged (1 day)</time_frame>
    <description>Total number of days hospitalized for total knee replacement surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with hypnosis survey</measure>
    <time_frame>Pre-op and 2 weeks post-op</time_frame>
    <description>Attitudes and expectations regarding hypnosis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Hypnosis</condition>
  <condition>Perioperative Care</condition>
  <condition>Knee Arthroplasty, Total</condition>
  <condition>Postoperative Pain</condition>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Hypnosis Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo a brief hypnotic assessment, a single hypnosis session with an MD trained in hypnosis, and be given a phone number to listen to a guided self-hypnosis recording for 1 week pre-op until 2 weeks post-op.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These patients will be enrolled in the study and usual care will be provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hypnosis</intervention_name>
    <description>Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.</description>
    <arm_group_label>Hypnosis Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years old.&#xD;
&#xD;
          -  scheduled for a primary, unilateral, total knee replacement surgery within the study&#xD;
             period&#xD;
&#xD;
          -  able to commit to a single study clinic visit at least one week prior to their&#xD;
             scheduled surgery and use of phone recordings&#xD;
&#xD;
          -  able to read and understand English&#xD;
&#xD;
          -  Score at least 25 on mini-mental state exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe psychiatric or structural brain disease (ie. psychosis, stroke with functional&#xD;
             impairment, dementia)&#xD;
&#xD;
          -  current use of hypnosis/self-hypnosis&#xD;
&#xD;
          -  enrolled in other clinical trials related to pain management or length of stay&#xD;
&#xD;
          -  hearing impairment that would impede ability to listen to a phone recording&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University/Stanford Healthcare</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 23, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Jessie Kittle</investigator_full_name>
    <investigator_title>Clinical Instructor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Hypnosis</keyword>
  <keyword>Hypnotherapy</keyword>
  <keyword>Perioperative Pain Management</keyword>
  <keyword>Narcotic reduction</keyword>
  <keyword>Perioperative Outcomes</keyword>
  <keyword>Total knee replacement</keyword>
  <keyword>Total knee arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03308071
org study id: IRB-41122
nct id: NCT03308071
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to determine if teaching self-hypnosis techniques to patients
      prior to knee replacement surgery will decrease their pain medication requirements, pain
      medication side-effects, length of stay in the hospital, readmission rates, pain, anxiety,
      physical function, satisfaction scores, and cost of admission.
Patients will be recruited by through orthopedic surgery clinics or contacted by after
      pre-screening via chart review and given an information brochure. If they are interested in
      the trial will be emailed or given a paper copy of the consent form and scheduled for a
      single additional visit in the Integrative Medicine Center at Hoover Pavilion approximately 1
      week before surgery. At the single study visit, participants would be consented, then a
      mini-mental state test would be performed to determine if participants are eligible by a
      score of 25 or above. If eligible, participants would be asked to fill out surveys relating
      to demographics, attitudes and experience with hypnosis, and detailed pain medication usage.
      Then, participants would be randomized to hypnosis vs. no hypnosis. The hypnosis group will
      undergo a Hypnotic Induction Profile to score hypnotizability, then be lead through a
      hypnosis induction and read a perioperative symptom management script, then re-alerted from
      hypnosis. Patients in this group would then be asked to listen to the same hypnosis script on
      a telephone recording twice per day until after the surgery when participants feel they don't
      need it anymore.

      The control group will fill out the surveys and the study visit will end. Participants will
      be asked not to use any hypnosis until the trial period is over. Data regarding pain,
      activity, and satisfaction is already collected by email survey or by Ipad in orthopedic
      clinic at or before the pre-op visit, and 3 months post-op.

      Patients in the knee study will be asked to fill out the same surveys around the two week and
      six week post-op orthopedic clinic visits as well. One additional survey will be added at the
      2 week post-op visit to reassess attitudes and experience with hypnosis, and detailed pain
      medication usage. Those participants who do not fill out the survey will be called and/or
      emailed to remind them to fill it out.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
masking description: The treating team including surgeons, anesthesiologists, pain consultants, hospitalists who are in charge of administering pain medication and documenting outcomes will be blinded to the intervention.
measure: Narcotic use
time frame: Index hospitalization for total knee replacement, average 2-3 days
description: Total narcotic use during the hospital stay will be calculated in "morphine equivalents"
measure: Narcotic prescriptions
time frame: 1 month before, and 3 months and 1 year after joint replacement
description: Total narcotics prescribed in the outpatient setting
measure: Narcotic-associated side effects
time frame: Index hospitalization for total knee replacement, average 2-3 days
description: Incidence of delirium, constipation, urinary retention, respiratory depression
measure: UCLA activity scores
time frame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
description: Classifies the activity level of joint replacement patients
measure: KOOS Jr Survey
time frame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
description: Knee injury and osteoarthritis outcome score
measure: VR-12 Survey
time frame: At the pre-op visit with the surgeon and 2, 6 and 12 weeks post-op
description: Measures health-related quality of life
measure: Knee Society Score
time frame: At the pre-op visit with the surgeon and 12 weeks post-op
description: Prosthesis function and patients' functional abilities after total knee arthroplasty (TKA)
measure: Number of days hospitalized
time frame: Reported once , after patient is discharged (1 day)
description: Total number of days hospitalized for total knee replacement surgery
measure: Satisfaction with hypnosis survey
time frame: Pre-op and 2 weeks post-op
description: Attitudes and expectations regarding hypnosis
arm group label: Hypnosis Group
arm group type: Experimental
description: Participants will undergo a brief hypnotic assessment, a single hypnosis session with an MD trained in hypnosis, and be given a phone number to listen to a guided self-hypnosis recording for 1 week pre-op until 2 weeks post-op.
arm group label: Usual care
arm group type: No Intervention
description: These patients will be enrolled in the study and usual care will be provided.
intervention type: Behavioral
intervention name: Hypnosis
description: Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.
arm group label: Hypnosis Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Jessie Kittle
investigator title: Clinical Instructor of Medicine
mesh term: Postoperative Complications
sharing ipd: No