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

• ClinicalTrials.gov Identifier: NCT02230644
• Recruitment Status: Completed
• First Posted: September 3, 2014
• Last Update Posted: October 27, 2015
• Sponsor: Royal College of Music
• Collaborator: Imperial College London
• Information provided by (Responsible Party): Royal College of Music

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Surgery	Other: Enhanced clinical environment; Other: Other distraction	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation
• Study Start Date: November 2014
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: May 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Audio enhanced; Enhanced Clinical Environment: participants wait for their operation in the enhanced audio-visual booth.	Other: Enhanced clinical environment; Surgical booths containing artwork and calming background music.
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; Such as newspaper, magazine or the news on television
No Intervention: Ordinary; Participants wait for their operation in an ordinary, unenhanced booth

Outcome Measures

Primary Outcome Measures :

1. Decrease in complexity of physiological response shown from ECG data collected via biosensing electrodes [ Time Frame: Over 30 - 90 minutes ]

Secondary Outcome Measures :

1. Reduction in stress hormones and Th1/Th2 shift in immune biomarkers measured in saliva samples [ Time Frame: 30 - 90 minutes ]

Other Outcome Measures:

1. Reduction in state anxiety measured in psychological scales [ Time Frame: 30 - 90 minutes ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United Kingdom

Chelsea and Westminster Hospital

London, United Kingdom, SW10 9HS

Sponsors and Collaborators

Royal College of Music

Imperial College London

Investigators

• Principal Investigator: Danilo Mandic; Imperial College London
• Study Director: Aaron Williamon; Royal College of Music

More Information

• Responsible Party: Royal College of Music
• ClinicalTrials.gov Identifier: NCT02230644
• Other Study ID Numbers: SAL1415
• First Posted: September 3, 2014
• Last Update Posted: October 27, 2015
• Last Verified: October 2015