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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082494
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Postoperative Pain Device: Music via internet and noise canceling headphones Other: Beverages Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 1, 2020

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).




Primary Outcome Measures :
  1. Postoperative Wellbeing [ Time Frame: 1 day after surgery ]
    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 :
  1. Pain assessment [ Time Frame: approximately 2 hours after surgery ]
    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.

  2. Administered milligram of opioids for pain medication [ Time Frame: approximately 2 hours after surgery ]
    Assessment of administered morphine equivalents

  3. Postoperative complications in the postanaesthesia care unit [ Time Frame: approximately 2 hours after surgery ]
    Number of participants with following complications Delirium, postoperative cognitive dysfunction, postoperative nausea and vomiting, aspiration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082494


Contacts
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Contact: Gregor Schittek, MD (+43 316) 385-81819 gregor.schittek@medunigraz.at

Locations
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Austria
Medical University Hospital LKH Graz Recruiting
Graz, Austria, 8036
Contact: Andrea Berghofer, Mag.    0316/385-14909    andrea.berghofer@medunigraz.at   
Principal Investigator: Gregor A Schittek, MD         
Sponsors and Collaborators
Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04082494    
Other Study ID Numbers: Stand 04.03.2019
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After publications of our data, we plan to share our data in respect of local privacy data laws.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Graz:
wellbeing
Postoperative Pain
postoperative disturbances after anaesthesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms