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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230644
• Other study ID #: SAL1415
• Status: Completed
• Phase: N/A
• First received: August 29, 2014
• Last updated: October 26, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Royal College of Music
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Enhanced clinical environment
Surgical booths containing artwork and calming background music.
• Other distraction
Such as newspaper, magazine or the news on television

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal College of Music	Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction in state anxiety measured in psychological scales		30 - 90 minutes	No
Primary	Decrease in complexity of physiological response shown from ECG data collected via biosensing electrodes		Over 30 - 90 minutes	No
Secondary	Reduction in stress hormones and Th1/Th2 shift in immune biomarkers measured in saliva samples		30 - 90 minutes	No