Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery (SPACU-lab)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Stress, Psychological; Stress, Physiological; Surgical Injury
• Intervention / Treatment: Other: implementation of a bundle of non-pharmacological interventions aimed at stress reduction

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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Suzanne Broens, PhD; Phone Number: 0205122506; Email: s.broens@nki.nl

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adults scheduled for intermediate to major oncological surgery in a tertiary referral cancer centre in the Netherlands

Description

Inclusion Criteria:

• ASA 1-3
• scheduled for intermediate to major oncological surgery
• with a minimum duration of 120 mins

Exclusion Criteria:

• Neuraxial anesthetic technique
• planned for postoperative ICU admission
• day case surgery
• Indication for peri-operative steroids
• chronic use of steroids
• Bronchial hyperreactivity

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: implementation of a bundle of non-pharmacological interventions aimed at stress reduction; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum cortisol level on POD1	serum cortisol level on postoperative day 1	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum IL-6, glucose, CRP, NLR on POD 1	serum IL-6, glucose, CRP, NLR on postoperative day 1	24 hours

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: stress; analgesia; non-pharamacological; postoperative; surgical stress response; post anesthesia care unit
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Stress, Psychological; Intraoperative Complications
• Other Study ID Numbers: N22SCL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No