NCT04082494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,613

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

September 5, 2019

Last Update Submit

July 20, 2020

Conditions

Postoperative ComplicationsPostoperative Pain

Keywords

wellbeingPostoperative Painpostoperative disturbances after anaesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain assessment

    approximately 2 hours after surgery

  • Administered milligram of opioids for pain medication

    approximately 2 hours after surgery

  • Postoperative complications in the postanaesthesia care unit

    approximately 2 hours after surgery

Study Arms (3)

Regular Treatment

NO INTERVENTION

No intervention is planned for the first period. "Baseline" treatment assesment.

Music

EXPERIMENTAL

Optional music via internet and noise canceling headphones will be offered.

Device: Music via internet and noise canceling headphones

Music and Beverages

EXPERIMENTAL

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 headphonesOther: Beverages

Interventions

Music via internet and noise canceling headphonesDEVICE

Optional music via internet and noise canceling headphones will be offered.

MusicMusic and Beverages
BeveragesOTHER

Beverages will be optionally offered (with and without sugar, warm or cold).

Music and Beverages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Hospital LKH Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Postoperative ComplicationsPain, Postoperative

Interventions

Beverages

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

September 2, 2019

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

July 21, 2020

Record last verified: 2020-07

Locations

AU(1)