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CompletedNCT02230644Updated Oct 27, 2015

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

An interventional study of Enhanced clinical environment and Other distraction in Surgery, sponsored by Royal College of Music. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-27.

Sponsored by Royal College of Music · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Surgery
03

In context

Lead sponsor

Royal College of Music is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Audio enhanced

    Enhanced Clinical Environment: participants wait for their operation in the enhanced audio-visual booth.

    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

    Other: Other distraction

  • No intervention
    Ordinary

    Participants wait for their operation in an ordinary, unenhanced booth

Interventions

  • OtherEnhanced clinical environment

    Surgical booths containing artwork and calming background music.

  • OtherOther distraction

    Such as newspaper, magazine or the news on television

06

What researchers measure

Primary outcomes

  1. Decrease in complexity of physiological response shown from ECG data collected via biosensing electrodes

    Time frame: Over 30 - 90 minutes

Secondary outcomes

  1. Reduction in stress hormones and Th1/Th2 shift in immune biomarkers measured in saliva samples

    Time frame: 30 - 90 minutes

Other outcomes

  1. Reduction in state anxiety measured in psychological scales

    Time frame: 30 - 90 minutes

07

Study locations

1 site
  • Chelsea and Westminster Hospital
    London, SW10 9HS, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02230644
Lead sponsor
Royal College of Music
Collaborators
Imperial College London
Responsible party
Sponsor
First posted
Sep 3, 2014
Start date
Nov 2014
Primary completion
Feb 2015
Completion
May 2015
Last update
Oct 27, 2015

Study contacts

Danilo Mandic
principal investigator · Imperial College London
Aaron Williamon
study director · Royal College of Music

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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