Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery
SPACU-lab
1 other identifier
observational
90
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedMarch 20, 2023
November 1, 2022
8 months
November 25, 2022
March 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum cortisol level on POD1
serum cortisol level on postoperative day 1
24 hours
Secondary Outcomes (1)
serum IL-6, glucose, CRP, NLR on POD 1
24 hours
Study Arms (2)
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
Interventions
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
Eligibility Criteria
Adults scheduled for intermediate to major oncological surgery in a tertiary referral cancer centre in the Netherlands
You may qualify if:
- ASA 1-3
- scheduled for intermediate to major oncological surgery
- with a minimum duration of 120 mins
You may not qualify if:
- Neuraxial anesthetic technique
- planned for postoperative ICU admission
- day case surgery
- Indication for peri-operative steroids
- chronic use of steroids
- Bronchial hyperreactivity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Blood samples (3x 15 ml) for cortisol, IL-6, CRP, glucose, neutrophil-lymphocyte ratio
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2022
First Posted
December 6, 2022
Study Start
May 1, 2023
Primary Completion
December 31, 2023
Study Completion
February 1, 2024
Last Updated
March 20, 2023
Record last verified: 2022-11