<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/NCT01663025</url>
  </required_header>
  <id_info>
    <org_study_id>WC1HM</org_study_id>
    <nct_id>NCT01663025</nct_id>
  </id_info>
  <brief_title>The Effects of Intra Operative Hand Reflexology for Patients Receiving Out Patient Vein Surgery</brief_title>
  <official_title>Evaluating The Effects Of Intra Operative Hand Reflexology on Pain and Anxiety During Out Patient Vein Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Whiteley Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Whiteley Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomised controlled trial aims to compare the effectiveness of hand reflexology&#xD;
      received during office based vein surgery, under local anaesthetic on patient's reports of&#xD;
      pain and anxiety, compared to usual standard care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The negative effects of anxiety and pain on surgical recovery are well documented. It is also&#xD;
      accepted that distraction can be effective in pain reduction. This randomised controlled&#xD;
      trial will explore the effect of intra operative hand reflexology on pain perception and&#xD;
      anxiety during office-based surgery under local anaesthetic. Participants will be randomly&#xD;
      allocated to either the experimental condition, in which they will receive a hand reflexology&#xD;
      during treatment, or control condition in which they will receive usual standard care.&#xD;
      Immediate and longer term outcomes will be explored.&#xD;
&#xD;
      Eight weeks after surgery, participants will return to the clinic for a follow up&#xD;
      appointment. While they are in the waiting area they will be asked to complete a short&#xD;
      questionnaire to assess time taken to return to pre surgical levels of functioning, pain&#xD;
      experienced in the first four weeks after surgery, severity of venous symptoms and&#xD;
      satisfaction with treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>In the recovery area, immediately after surgery</time_frame>
    <description>Participants will complete a numeric rating scale (0 no pain - 10, extreme pain) to assess any painful sensations experienced during treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>In the recovery area, immediately after surgery</time_frame>
    <description>Participants will complete a numeric rating scale(0, no anxiety to 10, extreme anxiety)to assess any anxiety they experienced during treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with treatment</measure>
    <time_frame>in the recovery area, immediately after surgery</time_frame>
    <description>Participants will be asked to rate how satisfied they are with the treatment that they have received on a scale of 1 (very dissatisfied) to 5 (very satisfied).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pain</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Hand Reflexology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will receive hand reflexology, performed by a trained reflexologist during their treatment. This will be in addition to usual standard care therefore the surgeon will speak to the participant occasionally to ensure they are comfortable.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in condition will form the control group for the study. They will receive usual standard care during treatment which will involve the surgeon speaking to them occasionally to ensure that they are comfortable.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hand Reflexology</intervention_name>
    <description>The hand reflexology will begin in theatre, before the local anaesthetic is administered and will continue until the patient is ready to leave the operating theatre.</description>
    <arm_group_label>Hand Reflexology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be aged between 18 and 80&#xD;
&#xD;
          -  To be able to give informed consent&#xD;
&#xD;
          -  To be receiving, endovenous laser ablation or phlebectomies for the treatment of&#xD;
             varicose veins&#xD;
&#xD;
          -  To have a good understanding of written and spoken English.&#xD;
&#xD;
          -  To arrive at the clinic with sufficient time before their procedure to give consent&#xD;
             and complete the questionnaire (&gt;20 mins)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -To be aged under 18 or over 80&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Whiteley</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Whiteley Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Whiteley Clinic at the Wimpole Clinic</name>
      <address>
        <city>London</city>
        <zip>W1U 4DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>May 16, 2014</last_update_submitted>
  <last_update_submitted_qc>May 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Randomised controlled trial</keyword>
  <keyword>Pain</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Ambulatory surgery</keyword>
  <keyword>Hand massage</keyword>
  <keyword>Local anaesthetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</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/NCT01663025
org study id: WC1HM
nct id: NCT01663025
lead sponsor: 
has dmc: Yes
This randomised controlled trial aims to compare the effectiveness of hand reflexology
      received during office based vein surgery, under local anaesthetic on patient's reports of
      pain and anxiety, compared to usual standard care.
The negative effects of anxiety and pain on surgical recovery are well documented. It is also
      accepted that distraction can be effective in pain reduction. This randomised controlled
      trial will explore the effect of intra operative hand reflexology on pain perception and
      anxiety during office-based surgery under local anaesthetic. Participants will be randomly
      allocated to either the experimental condition, in which they will receive a hand reflexology
      during treatment, or control condition in which they will receive usual standard care.
      Immediate and longer term outcomes will be explored.

      Eight weeks after surgery, participants will return to the clinic for a follow up
      appointment. While they are in the waiting area they will be asked to complete a short
      questionnaire to assess time taken to return to pre surgical levels of functioning, pain
      experienced in the first four weeks after surgery, severity of venous symptoms and
      satisfaction with treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain
time frame: In the recovery area, immediately after surgery
description: Participants will complete a numeric rating scale (0 no pain - 10, extreme pain) to assess any painful sensations experienced during treatment
measure: Anxiety
time frame: In the recovery area, immediately after surgery
description: Participants will complete a numeric rating scale(0, no anxiety to 10, extreme anxiety)to assess any anxiety they experienced during treatment.
measure: Satisfaction with treatment
time frame: in the recovery area, immediately after surgery
description: Participants will be asked to rate how satisfied they are with the treatment that they have received on a scale of 1 (very dissatisfied) to 5 (very satisfied).
arm group label: Hand Reflexology
arm group type: Experimental
description: Participants in this condition will receive hand reflexology, performed by a trained reflexologist during their treatment. This will be in addition to usual standard care therefore the surgeon will speak to the participant occasionally to ensure they are comfortable.
arm group label: Control
arm group type: No Intervention
description: Participants in condition will form the control group for the study. They will receive usual standard care during treatment which will involve the surgeon speaking to them occasionally to ensure that they are comfortable.
intervention type: Behavioral
intervention name: Hand Reflexology
description: The hand reflexology will begin in theatre, before the local anaesthetic is administered and will continue until the patient is ready to leave the operating theatre.
arm group label: Hand Reflexology
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mark Whiteley
role: Principal Investigator
affiliation: The Whiteley Clinic
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Anxiety Disorders