<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/NCT02230644</url>
  </required_header>
  <id_info>
    <org_study_id>SAL1415</org_study_id>
    <nct_id>NCT02230644</nct_id>
  </id_info>
  <brief_title>RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation</brief_title>
  <official_title>RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal College of Music</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal College of Music</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Over 4.6 million operations are undertaken each year in England alone. Of these, many&#xD;
      patients experience psychological distress, which has negative implications for patient&#xD;
      recovery. Indeed, psychological stress, in particular both trait and state anxiety, anger and&#xD;
      distress, has been linked with slower wound healing (Broadbent et al., 2003) and more&#xD;
      complicated post-operative recovery (Johnston and Wallace, 1990).&#xD;
&#xD;
      However, pre-operative psychological interventions can have significant positive effects on&#xD;
      components of of post-operative recovery (Navros et al., 2011; Weinman and Johnston, 1988).&#xD;
      In particular, music has been studied in a series of randomised control trials as a way of&#xD;
      reducing pre-surgical stress. Studies have shown the effects of music in reducing levels of&#xD;
      stress hormones such as cortisol (Leardi et al., 2007) and reducing both heart rate and blood&#xD;
      pressure, and have also found music to be more effective than benzodiazepine at reducing&#xD;
      pre-surgical anxiety (Bringman et al., 2009).&#xD;
&#xD;
      Chelsea and Westminster Hospital NHS Foundation Trust is a major surgical hospital,&#xD;
      performing over 15,000 adult operations annually. Consequently, strategies to reduce patient&#xD;
      anxiety and improve experience are amongst the hospital's priorities. A renovation of the&#xD;
      Surgical Admissions Lounge is currently underway with plans to incorporate visual arts and&#xD;
      music in waiting booths to relax and distract patients. When asked how relaxing they found&#xD;
      the space, patients at Chelsea and Westminster Hospital involved in a public consultation&#xD;
      rated the current unenhanced waiting area as 5.8/10, but 93% of patients said that relaxing&#xD;
      music would help them feel less anxious. This project will test whether music and art in the&#xD;
      SAL actively reduce adult patient stress compared to normal unenhanced waiting spaces, with a&#xD;
      view to extending the arts interventions to other surgical waiting areas such as the day&#xD;
      treatment centre if there are significant positive findings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stress can be measured via a number of methods, including both psychological and&#xD;
      physiological. This study proposes to examine three signatures of stress in order to&#xD;
      triangulate data and achieve a more comprehensive understanding of patients' stress response:&#xD;
&#xD;
        1. Psychological - we will use validated psychological questionnaires including STAI to&#xD;
           measure both trait and state anxiety. We will also be using a simple prospective time&#xD;
           perception test and a Stroop test to assess whether patients' attention capacity.&#xD;
&#xD;
        2. Physiological - We will use biosensors and bioharnesses to gather electrocardiogram&#xD;
           (ECG) data in order to test the complexity loss hypothesis. This hypothesis states that&#xD;
           the physiological responses of organisms under constraints (ageing, illness, stress)&#xD;
           exhibit grossly reduced dynamics and lose the ability to adopt to the changes in the&#xD;
           environment. We will examine whether patients exhibit these reduced dynamics as their&#xD;
           operation approaches and whether the arts can be used to increase the complexity of&#xD;
           their responses.&#xD;
&#xD;
        3. Biological - we will take two small saliva (spit) samples from patients to test whether&#xD;
           levels of stress hormones such as cortisol are elevated in patients, and whether other&#xD;
           immune biomarkers such as pro-inflammatory cytokines TNF-alpha and IL-1 are reduced by&#xD;
           pre-surgical stress but maintained when music and art are present. Previous research&#xD;
           within the field of psychoneuroimmunology suggests that alterations in psychological&#xD;
           stress levels have consequences for biological response (Ader, 2007).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in complexity of physiological response shown from ECG data collected via biosensing electrodes</measure>
    <time_frame>Over 30 - 90 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in stress hormones and Th1/Th2 shift in immune biomarkers measured in saliva samples</measure>
    <time_frame>30 - 90 minutes</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Reduction in state anxiety measured in psychological scales</measure>
    <time_frame>30 - 90 minutes</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Audio enhanced</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enhanced Clinical Environment: participants wait for their operation in the enhanced audio-visual booth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other distraction method</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants wait for their operation in a booth with another distraction such as the news on television</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ordinary</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants wait for their operation in an ordinary, unenhanced booth</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced clinical environment</intervention_name>
    <description>Surgical booths containing artwork and calming background music.</description>
    <arm_group_label>Audio enhanced</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Other distraction</intervention_name>
    <description>Such as newspaper, magazine or the news on television</description>
    <arm_group_label>Other distraction method</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Male or Female, aged 18 years or above.&#xD;
&#xD;
          -  Awaiting an operation for which they will have to pass through the surgical admissions&#xD;
             lounge.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wearing of hearing aids (which would prevent participants from wearing the biosensors&#xD;
             in their ears)&#xD;
&#xD;
          -  Severely impaired sight or hearing (to the level that would affect their ability to&#xD;
             participate in the interventions)&#xD;
&#xD;
          -  A dementia that would compromise their ability to provide informed consent&#xD;
&#xD;
          -  A language barrier that prevents participants from being able to understand the PIS&#xD;
             and provide informed consent.&#xD;
&#xD;
          -  Pre-surgical sedative administered either prior to or during participation in the&#xD;
             study.&#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>Danilo Mandic</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aaron Williamon</last_name>
    <role>Study Director</role>
    <affiliation>Royal College of Music</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>October 26, 2015</last_update_submitted>
  <last_update_submitted_qc>October 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02230644
org study id: SAL1415
nct id: NCT02230644
lead sponsor: 
collaborator: 
has dmc: Yes
Over 4.6 million operations are undertaken each year in England alone. Of these, many
      patients experience psychological distress, which has negative implications for patient
      recovery. Indeed, psychological stress, in particular both trait and state anxiety, anger and
      distress, has been linked with slower wound healing (Broadbent et al., 2003) and more
      complicated post-operative recovery (Johnston and Wallace, 1990).

      However, pre-operative psychological interventions can have significant positive effects on
      components of of post-operative recovery (Navros et al., 2011; Weinman and Johnston, 1988).
      In particular, music has been studied in a series of randomised control trials as a way of
      reducing pre-surgical stress. Studies have shown the effects of music in reducing levels of
      stress hormones such as cortisol (Leardi et al., 2007) and reducing both heart rate and blood
      pressure, and have also found music to be more effective than benzodiazepine at reducing
      pre-surgical anxiety (Bringman et al., 2009).

      Chelsea and Westminster Hospital NHS Foundation Trust is a major surgical hospital,
      performing over 15,000 adult operations annually. Consequently, strategies to reduce patient
      anxiety and improve experience are amongst the hospital's priorities. A renovation of the
      Surgical Admissions Lounge is currently underway with plans to incorporate visual arts and
      music in waiting booths to relax and distract patients. When asked how relaxing they found
      the space, patients at Chelsea and Westminster Hospital involved in a public consultation
      rated the current unenhanced waiting area as 5.8/10, but 93% of patients said that relaxing
      music would help them feel less anxious. This project will test whether music and art in the
      SAL actively reduce adult patient stress compared to normal unenhanced waiting spaces, with a
      view to extending the arts interventions to other surgical waiting areas such as the day
      treatment centre if there are significant positive findings.
Stress can be measured via a number of methods, including both psychological and
      physiological. This study proposes to examine three signatures of stress in order to
      triangulate data and achieve a more comprehensive understanding of patients' stress response:

        1. Psychological - we will use validated psychological questionnaires including STAI to
           measure both trait and state anxiety. We will also be using a simple prospective time
           perception test and a Stroop test to assess whether patients' attention capacity.

        2. Physiological - We will use biosensors and bioharnesses to gather electrocardiogram
           (ECG) data in order to test the complexity loss hypothesis. This hypothesis states that
           the physiological responses of organisms under constraints (ageing, illness, stress)
           exhibit grossly reduced dynamics and lose the ability to adopt to the changes in the
           environment. We will examine whether patients exhibit these reduced dynamics as their
           operation approaches and whether the arts can be used to increase the complexity of
           their responses.

        3. Biological - we will take two small saliva (spit) samples from patients to test whether
           levels of stress hormones such as cortisol are elevated in patients, and whether other
           immune biomarkers such as pro-inflammatory cytokines TNF-alpha and IL-1 are reduced by
           pre-surgical stress but maintained when music and art are present. Previous research
           within the field of psychoneuroimmunology suggests that alterations in psychological
           stress levels have consequences for biological response (Ader, 2007).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Decrease in complexity of physiological response shown from ECG data collected via biosensing electrodes
time frame: Over 30 - 90 minutes
measure: Reduction in stress hormones and Th1/Th2 shift in immune biomarkers measured in saliva samples
time frame: 30 - 90 minutes
measure: Reduction in state anxiety measured in psychological scales
time frame: 30 - 90 minutes
arm group label: Audio enhanced
arm group type: Experimental
description: Enhanced Clinical Environment: participants wait for their operation in the enhanced audio-visual booth.
arm group label: Other distraction method
arm group type: Active Comparator
description: Participants wait for their operation in a booth with another distraction such as the news on television
arm group label: Ordinary
arm group type: No Intervention
description: Participants wait for their operation in an ordinary, unenhanced booth
intervention type: Other
intervention name: Enhanced clinical environment
description: Surgical booths containing artwork and calming background music.
arm group label: Audio enhanced
intervention type: Other
intervention name: Other distraction
description: Such as newspaper, magazine or the news on television
arm group label: Other distraction method
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Danilo Mandic
role: Principal Investigator
affiliation: Imperial College London
last name: Aaron Williamon
role: Study Director
affiliation: Royal College of Music
facility: 
country: United Kingdom
responsible party type: Sponsor