Surgical InjurySPACU-labNCT05638152
Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery
An observational study of Surgical Injury and Stress, Physiological, run by The Netherlands Cancer Institute.
Trial summary
Rationale: Surgical trauma and post-surgical pain induce a physiological stress response that can be detrimental to the patient. Non-pharmacological interventions aimed at stress reduction are known to reduce pain scores and opioid consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Injury, Stress, Physiological, Stress, Psychological
- What is being tested?
- implementation of a bundle of non-pharmacological interventions aimed at stress reduction
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Feb 2024
- Phase
- Observational
- 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
Study population: Adults scheduled for intermediate to major oncological surgery in a tertiary referral cancer centre in the Netherlands
Who may be able to join
- ASA 1-3
- scheduled for intermediate to major oncological surgery
- with a minimum duration of 120 mins
Who cannot join
- Neuraxial anesthetic technique
- planned for postoperative ICU admission
- day case surgery
- Indication for peri-operative steroids
- chronic use of steroids
- Bronchial hyperreactivity
Trial locations and contacts
No sites are listed yet.
About this study
Rationale: Surgical trauma and post-surgical pain induce a physiological stress response that can be detrimental to the patient. Non-pharmacological interventions aimed at stress reduction are known to reduce pain scores and opioid consumption. The effect of these interventions on the surgical stress response are unknown.
Objective: To assess the effect of a bundle of non-pharmacological interventions implemented in the post-anesthesia care unit on the total serum cortisol levels after intermediate and major surgery.
Read more
Study design: This is a prospective before-after study. Study population: Patients scheduled for intermediate or major oncological surgery in a tertiary referral cancer center.
Intervention: The implementation of a bundle of four non-pharmacological interventions aimed at stress reduction in the post-anesthesia care unit. The bundle consists of: access to music, aromatherapy, natural images on the walls and ceiling and communication techniques aimed at reduction of stress and pain.
Main study parameters/endpoints: Serum cortisol levels on the first postoperative day.
Read the detailed description
This protocol is a substudy of a larger observational before-after study that studies the effects of the planned implementation of a bundle of non-pharmacological interventions in the post-anesthesia care unit on pain scores, opioid consumption and quality of recovery.
In this current protocol, a subset of 90 surgical patients of a tertiary referral cancer centre in the Netherlands will be included and will be asked to provide informed consent for additional blood samples to be drawn to study the effects of the stress-reducing bundle on biomarkers of the surgical stress response.
45 eligible patients will be approached in the before-arm of the study and 45 will be included for the after-arm. Inclusion criteria are: planned for intermediate to major oncological surgery with an expected duration of >120 minutes, without the use of neuraxial anesthetic techniques. Patients with a planned postoperative ICU-admission will be excluded. After providing informed consent, they will be asked to complete a Quality of Recovery (QoR-15) questionnaire prior to surgery. Additional blood will be drawn with their routine preoperative blood sample on the morning of surgery to determine levels of cortisol, interleukine-6 (IL-6), glucose, C-reactive protein (CRP) and Neutrophil-Lymphocyte Ratio(NLR). The same blood sample will be drawn on arrival in the PACU and on the morning of the first postoperative day. Patients will also be asked to complete the QoR-15 questionnaire again on the first postoperative day.
The primary outcome will be serum cortisol level on the first postoperative day (as a biomarker of the surgical stress response).
- Being tested
- implementation of a bundle of non-pharmacological interventions aimed at stress reduction
- Keywords
- non-pharamacological, analgesia, stress, postoperative, surgical stress response, post anesthesia care unit
- Medical subject headings
- Intraoperative Complications, Stress, Psychological, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation of a bundle of non-pharmacological interventions aimed at stress reductionOther
The bundle consists of 4 interventions:
- natural imagery in the PACU (wall length decorations and lighted ceiling panels with sky views
- Aromatherapy with fragrances selected for anxiolytic and antiemetic properties
- Music available to patients
- Comfort Talk communication course for PACU nurses
| Study group | Role | What they receive |
|---|---|---|
| before | routine care | |
| after | routine care + natural imagery in the PACU + access to music + access to aromatherapy + use of hypnoidal communication techniques by PACU nurses Receives: Other: implementation of a bundle of non-pharmacological interventions aimed at stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum cortisol level on POD1
serum cortisol level on postoperative day 1
Measured: 24 hours
Secondary outcomes (1)
serum IL-6, glucose, CRP, NLR on POD 1
serum IL-6, glucose, CRP, NLR on postoperative day 1
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical InjuryStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638152
- Sponsor's protocol ID
- N22SCL
- Acronym
- SPACU-lab
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery
- ClinicalTrials.gov ID
- NCT05638152
- Acronym / sponsor ID
- SPACU-lab / N22SCL
- Keywords
- non-pharamacological, analgesia, stress, postoperative, surgical stress response, post anesthesia care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- 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.
Rationale: Surgical trauma and post-surgical pain induce a physiological stress response that can be detrimental to the patient. Non-pharmacological interventions aimed at stress reduction are known to reduce pain scores and opioid consumption. The effect of these interventions on the surgical stress response are unknown.
Objective: To assess the effect of a bundle of non-pharmacological interventions implemented in the post-anesthesia care unit on the total serum cortisol levels after intermediate and major surgery.
Study design: This is a prospective before-after study. Study population: Patients scheduled for intermediate or major oncological surgery in a tertiary referral cancer center.
Intervention: The implementation of a bundle of four non-pharmacological interventions aimed at stress reduction in the post-anesthesia care unit. The bundle consists of: access to music, aromatherapy, natural images on the walls and ceiling and communication techniques aimed at reduction of stress and pain.
Main study parameters/endpoints: Serum cortisol levels on the first postoperative day.
Detailed description
This protocol is a substudy of a larger observational before-after study that studies the effects of the planned implementation of a bundle of non-pharmacological interventions in the post-anesthesia care unit on pain scores, opioid consumption and quality of recovery.
In this current protocol, a subset of 90 surgical patients of a tertiary referral cancer centre in the Netherlands will be included and will be asked to provide informed consent for additional blood samples to be drawn to study the effects of the stress-reducing bundle on biomarkers of the surgical stress response.
45 eligible patients will be approached in the before-arm of the study and 45 will be included for the after-arm. Inclusion criteria are: planned for intermediate to major oncological surgery with an expected duration of >120 minutes, without the use of neuraxial anesthetic techniques. Patients with a planned postoperative ICU-admission will be excluded. After providing informed consent, they will be asked to complete a Quality of Recovery (QoR-15) questionnaire prior to surgery. Additional blood will be drawn with their routine preoperative blood sample on the morning of surgery to determine levels of cortisol, interleukine-6 (IL-6), glucose, C-reactive protein (CRP) and Neutrophil-Lymphocyte Ratio(NLR). The same blood sample will be drawn on arrival in the PACU and on the morning of the first postoperative day. Patients will also be asked to complete the QoR-15 questionnaire again on the first postoperative day.
The primary outcome will be serum cortisol level on the first postoperative day (as a biomarker of the surgical stress response).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before | – | –routine care |
| after | – | Other: implementation of a bundle of non-pharmacological interventions aimed at stress reductionroutine care + natural imagery in the PACU + access to music + access to aromatherapy + use of hypnoidal communication techniques by PACU nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults scheduled for intermediate to major oncological surgery in a tertiary referral cancer centre in the Netherlands
Key inclusion criteria (3 listed)
- ASA 1-3
- scheduled for intermediate to major oncological surgery
- with a minimum duration of 120 mins
Key exclusion criteria (6 listed)
- Neuraxial anesthetic technique
- planned for postoperative ICU admission
- day case surgery
- Indication for peri-operative steroids
- chronic use of steroids
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 |
|---|---|---|
| implementation of a bundle of non-pharmacological interventions aimed at stress reductionThe bundle consists of 4 interventions: * natural imagery in the PACU (wall length decorations and lighted ceiling panels with sky views * Aromatherapy with fragrances selected for anxiolytic and antiemetic properties * Music available to patients * Comfort Talk communication course for PACU nurses | Other | after |
Primary outcome
serum cortisol level on POD1
Time frame: 24 hours
serum cortisol level on postoperative day 1
1 secondary outcome
serum IL-6, glucose, CRP, NLR on POD 1
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Injury and Stress, Physiological, run by The Netherlands Cancer Institute.
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 6 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Broens, PhD (0205122506, s.broens@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum cortisol level on POD1 (time frame: 24 hours). 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 20 Mar 2023.