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

Postoperative Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082494
• Other study ID #: Stand 04.03.2019
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: July 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1613
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Complications
• Postoperative Pain

Intervention

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).

Locations

Country	Name	City	State
Austria	Medical University Hospital LKH Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Administered milligram of opioids for pain medication	Assessment of administered morphine equivalents	approximately 2 hours after surgery
Secondary	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