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Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery

NCT05638152 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2023-03-20

No results posted yet for this study

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.

Conditions

  • Surgical Injury
  • Stress, Physiological
  • Stress, Psychological
  • Pain, Postoperative

Interventions

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

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-12-31
Completion
2024-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05638152 on ClinicalTrials.gov