SurgeryNCT02230644
RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation
A study testing Enhanced clinical environment and Other distraction in people with Surgery, run by Royal College of Music at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Enhanced clinical environment and Other distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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.
- 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.
- 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).
- Conditions
- Surgery
- Being tested
- Enhanced clinical environment, Other distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced clinical environmentOther
Surgical booths containing artwork and calming background music.
Other distractionOther
Such as newspaper, magazine or the news on television
| Study group | Role | What they receive |
|---|---|---|
| Audio enhanced | Experimental | Enhanced Clinical Environment: participants wait for their operation in the enhanced audio-visual booth. Receives: 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 Receives: Other: Other distraction |
| Ordinary | No intervention | Participants wait for their operation in an ordinary, unenhanced booth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in complexity of physiological response shown from ECG data collected via biosensing electrodes
Measured: Over 30 - 90 minutes
Secondary outcomes (1)
Reduction in stress hormones and Th1/Th2 shift in immune biomarkers measured in saliva samples
Measured: 30 - 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Music
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Danilo Mandic, Principal investigator, Imperial College LondonAaron Williamon, Study director, Royal College of Music
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230644
- Sponsor's protocol ID
- SAL1415
- Status last verified
- Oct 2015
- First submitted
- 29 Aug 2014
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELAX Surgical: Effects of Environmental Design on Pre-surgical Relaxation
- ClinicalTrials.gov ID
- NCT02230644
- Acronym / sponsor ID
- SAL1415
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Royal College of MusicUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Audio enhanced | Experimental | Other: Enhanced clinical environmentEnhanced Clinical Environment: participants wait for their operation in the enhanced audio-visual booth. |
| Other distraction method | Active comparator | Other: Other distractionParticipants wait for their operation in a booth with another distraction such as the news on television |
| Ordinary | No intervention | –Participants wait for their operation in an ordinary, unenhanced booth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced clinical environmentSurgical booths containing artwork and calming background music. | Other | Audio enhanced |
| Other distractionSuch as newspaper, magazine or the news on television | Other | Other distraction method |
Primary outcome
Decrease in complexity of physiological response shown from ECG data collected via biosensing electrodes
Time frame: Over 30 - 90 minutes
1 secondary outcome
Reduction in stress hormones and Th1/Th2 shift in immune biomarkers measured in saliva samples
Time frame: 30 - 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danilo Mandic principal investigator
Imperial College London
Aaron Williamon study director
Royal College of Music
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced clinical environment and Other distraction in people with Surgery, run by Royal College of Music at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in complexity of physiological response shown from ECG data collected via biosensing electrodes (time frame: Over 30 - 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.