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

NCT02230644 | Completed DMC

• 1 other identifier: SAL1415
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

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

  Over 30 - 90 minutes

Secondary Outcomes (1)

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

  30 - 90 minutes

Other Outcomes (1)

• Reduction in state anxiety measured in psychological scales

  30 - 90 minutes

Study Arms (3)

Audio enhanced

EXPERIMENTAL

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

Other: Enhanced clinical environment

Other distraction method

ACTIVE COMPARATOR

Participants wait for their operation in a booth with another distraction such as the news on television

Other: Other distraction

Ordinary

NO INTERVENTION

Participants wait for their operation in an ordinary, unenhanced booth

Interventions

Enhanced clinical environment OTHER

Surgical booths containing artwork and calming background music.

Audio enhanced

Other distraction OTHER

Such as newspaper, magazine or the news on television

Other distraction method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Music: lead
• Imperial College London: collaborator

Study Sites (1)

Chelsea and Westminster Hospital

London, SW10 9HS, United Kingdom

Location

Study Officials

• Danilo Mandic

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Aaron Williamon

  Royal College of Music

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

GB (1)