Impact on Postoperative Wellbeing in the Post-anaesthesia Care Anaesthesia (PACU) of Personalized Music and Beverages.

Impact on Postoperative Wellbeing in the PACU After General or Regional Anaesthesia Through Consecutive Implementation of Personalized Musical Entertainment and a Variety of Beverages. A Pre-post-post Analysis.

Postoperative disturbances for patients' well-being in the PACU after general or spinal anaesthesia will be assessed. Influence of the offer of beverages and music will be assessed regarding their wellbeing, satisfaction and pain.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Pain
• Intervention / Treatment: Device: Music via internet and noise canceling headphones; Other: Beverages

• Study Type: Interventional
• Enrollment (Actual): 1613
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University Hospital LKH Graz

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• elective stationary adult patients capable and willing of filling out the questionnaire

Exclusion Criteria:

• participation in other studies about wellbeing influence
• incapability of filling out the questionnaire
• patients that do not wish to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Regular Treatment; No intervention is planned for the first period. "Baseline" treatment assesment.
Experimental: Music; Optional music via internet and noise canceling headphones will be offered.	Device: Music via internet and noise canceling headphones; Optional music via internet and noise canceling headphones will be offered.
Experimental: Music and Beverages; Additionally to the offered optional music via internet and noise canceling headphones, there will be beverages optionally offered (with and without sugar, warm or cold).	Device: Music via internet and noise canceling headphones; Optional music via internet and noise canceling headphones will be offered.; Other: Beverages; Beverages will be optionally offered (with and without sugar, warm or cold).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Wellbeing	Assessed with the post anaesthesiological questionnaire (ANP) Wellbeing assessed with the "Anaesthesiological Questionnaire" (ANP) which is a self-rating method for the assessment of postoperative complaints and patient wellbeing. The rating scales from 0 to 3, with 0="none" and 3="strongly". Higher wellbeing values represent a better outcome.	1 day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Numeric Rating Scale (NRS) in the postanaesthesia care unit. Pain will be assessed with the (verbal) Numerical Rating Scale (NRS) and statistically evaluated for differences between the two study groups. NRS scales from 1 to 10, with 1 describing the lowest pain score and 10 the highest pain score. Lower NRS describes a better outcome.	approximately 2 hours after surgery
Administered milligram of opioids for pain medication	Assessment of administered morphine equivalents	approximately 2 hours after surgery
Postoperative complications in the postanaesthesia care unit	Number of participants with following complications Delirium, postoperative cognitive dysfunction, postoperative nausea and vomiting, aspiration	approximately 2 hours after surgery

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative Pain; wellbeing; postoperative disturbances after anaesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pain, Postoperative; Postoperative Complications
• Other Study ID Numbers: Stand 04.03.2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After publications of our data, we plan to share our data in respect of local privacy data laws.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No