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NCT05638152
Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery
Conditions: Surgical Injury, Stress, Physiological, Stress, Psychological, Pain, Postoperative
Sex: All
Ages: 18 Years – N/A
Enrollment: 90
Sponsor: The Netherlands Cancer Institute
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.
Eligibility Criteria
Inclusion Criteria:ASA 1-3scheduled for intermediate to major oncological surgerywith a minimum duration of 120 minsExclusion Criteria:Neuraxial anesthetic techniqueplanned for postoperative ICU admissionday case surgeryIndication for peri-operative steroidschronic use of steroidsBronchial hyperreactivity
Source: ClinicalTrials.gov (NCT05638152). StuddyBuddy aggregates publicly available trial information.