Back to resultsImpact on Postoperative Wellbeing in the Post-anaesthesia Care Anaesthesia (PACU) of Personalized Music and Beverages.
Primary Purpose
Postoperative Complications, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Music via internet and noise canceling headphones
Beverages
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Complications focused on measuring wellbeing, Postoperative Pain, postoperative disturbances after anaesthesia
Eligibility Criteria
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
Sites / Locations
- Medical University Hospital LKH Graz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Regular Treatment
Music
Music and Beverages
Arm Description
No intervention is planned for the first period. "Baseline" treatment assesment.
Optional music via internet and noise canceling headphones will be offered.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Administered milligram of opioids for pain medication
Assessment of administered morphine equivalents
Postoperative complications in the postanaesthesia care unit
Number of participants with following complications Delirium, postoperative cognitive dysfunction, postoperative nausea and vomiting, aspiration
Full Information
NCT ID
NCT04082494
First Posted
September 5, 2019
Last Updated
July 20, 2020
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT04082494
Brief Title
Impact on Postoperative Wellbeing in the Post-anaesthesia Care Anaesthesia (PACU) of Personalized Music and Beverages.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Postoperative Pain
Keywords
wellbeing, Postoperative Pain, postoperative disturbances after anaesthesia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1613 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regular Treatment
Arm Type
No Intervention
Arm Description
No intervention is planned for the first period. "Baseline" treatment assesment.
Arm Title
Music
Arm Type
Experimental
Arm Description
Optional music via internet and noise canceling headphones will be offered.
Arm Title
Music and Beverages
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Music via internet and noise canceling headphones
Intervention Description
Optional music via internet and noise canceling headphones will be offered.
Intervention Type
Other
Intervention Name(s)
Beverages
Intervention Description
Beverages will be optionally offered (with and without sugar, warm or cold).
Primary Outcome Measure Information:
Title
Postoperative Wellbeing
Description
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.
Time Frame
1 day after surgery
Secondary Outcome Measure Information:
Title
Pain assessment
Description
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.
Time Frame
approximately 2 hours after surgery
Title
Administered milligram of opioids for pain medication
Description
Assessment of administered morphine equivalents
Time Frame
approximately 2 hours after surgery
Title
Postoperative complications in the postanaesthesia care unit
Description
Number of participants with following complications Delirium, postoperative cognitive dysfunction, postoperative nausea and vomiting, aspiration
Time Frame
approximately 2 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University Hospital LKH Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
After publications of our data, we plan to share our data in respect of local privacy data laws.
Learn more about this trial
Impact on Postoperative Wellbeing in the Post-anaesthesia Care Anaesthesia (PACU) of Personalized Music and Beverages.
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