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RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02230644
Recruitment Status : Completed
First Posted : September 3, 2014
Last Update Posted : October 27, 2015
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Royal College of Music

Tracking Information
First Submitted Date  ICMJE August 29, 2014
First Posted Date  ICMJE September 3, 2014
Last Update Posted Date October 27, 2015
Study Start Date  ICMJE November 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
Decrease in complexity of physiological response shown from ECG data collected via biosensing electrodes [ Time Frame: Over 30 - 90 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
Reduction in stress hormones and Th1/Th2 shift in immune biomarkers measured in saliva samples [ Time Frame: 30 - 90 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 29, 2014)
Reduction in state anxiety measured in psychological scales [ Time Frame: 30 - 90 minutes ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation
Official Title  ICMJE RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation
Brief Summary

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.

Detailed Description

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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Surgery
Intervention  ICMJE
  • Other: Enhanced clinical environment
    Surgical booths containing artwork and calming background music.
  • Other: Other distraction
    Such as newspaper, magazine or the news on television
Study Arms  ICMJE
  • Experimental: Audio enhanced
    Enhanced Clinical Environment: participants wait for their operation in the enhanced audio-visual booth.
    Intervention: Other: Enhanced clinical environment
  • Active Comparator: Other distraction method
    Participants wait for their operation in a booth with another distraction such as the news on television
    Intervention: Other: Other distraction
  • No Intervention: Ordinary
    Participants wait for their operation in an ordinary, unenhanced booth
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Awaiting an operation for which they will have to pass through the surgical admissions lounge.

Exclusion Criteria:

  • Wearing of hearing aids (which would prevent participants from wearing the biosensors in their ears)
  • Severely impaired sight or hearing (to the level that would affect their ability to participate in the interventions)
  • A dementia that would compromise their ability to provide informed consent
  • A language barrier that prevents participants from being able to understand the PIS and provide informed consent.
  • Pre-surgical sedative administered either prior to or during participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02230644
Other Study ID Numbers  ICMJE SAL1415
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royal College of Music
Study Sponsor  ICMJE Royal College of Music
Collaborators  ICMJE Imperial College London
Investigators  ICMJE
Principal Investigator: Danilo Mandic Imperial College London
Study Director: Aaron Williamon Royal College of Music
PRS Account Royal College of Music
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP