Postoperative ComplicationsNCT04082494
Impact on Postoperative Wellbeing in the Post-anaesthesia Care Anaesthesia (PACU) of Personalized Music and Beverages.
A study testing Music via internet and noise canceling headphones and Beverages in people with Postoperative Complications and Postoperative Pain, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Postoperative Pain
- What is being tested?
- Music via internet and noise canceling headphones and Beverages
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,613 participants
- Where
- 1 siteAustria
- Study dates
- 2 Sep 2019to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective stationary adult patients capable and willing of filling out the questionnaire
Who cannot join
- participation in other studies about wellbeing influence
- incapability of filling out the questionnaire
- patients that do not wish to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Postoperative Complications, Postoperative Pain
- Being tested
- Music via internet and noise canceling headphones, Beverages
- Keywords
- wellbeing, Postoperative Pain, postoperative disturbances after anaesthesia
- Medical subject headings
- Postoperative Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music via internet and noise canceling headphonesDevice
Optional music via internet and noise canceling headphones will be offered.
BeveragesOther
Beverages will be optionally offered (with and without sugar, warm or cold).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Music via internet and noise canceling headphones; Other: Beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day after surgery
Secondary outcomes (3)
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.
Measured: approximately 2 hours after surgery
Administered milligram of opioids for pain medication
Assessment of administered morphine equivalents
Measured: 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
Measured: approximately 2 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start2 Sep 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082494
- Sponsor's protocol ID
- Stand 04.03.2019
- Status last verified
- Jul 2020
- First submitted
- 5 Sep 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After publications of our data, we plan to share our data in respect of local privacy data laws.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04082494
- Acronym / sponsor ID
- Stand 04.03.2019
- Conditions
- Postoperative Complications, Postoperative Pain
- Keywords
- wellbeing, Postoperative Pain, postoperative disturbances after anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,613 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular Treatment | No intervention | –No intervention is planned for the first period. "Baseline" treatment assesment. |
| Music | Experimental | Device: Music via internet and noise canceling headphonesOptional music via internet and noise canceling headphones will be offered. |
| Music and Beverages | Experimental | Device: Music via internet and noise canceling headphones, Other: BeveragesAdditionally to the offered optional music via internet and noise canceling headphones, there will be beverages optionally offered (with and without sugar, warm or cold). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective stationary adult patients capable and willing of filling out the questionnaire
Key exclusion criteria (3 listed)
- participation in other studies about wellbeing influence
- incapability of filling out the questionnaire
- patients that do not wish to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music via internet and noise canceling headphonesOptional music via internet and noise canceling headphones will be offered. | Device | Music, Music and Beverages |
| BeveragesBeverages will be optionally offered (with and without sugar, warm or cold). | Other | Music and Beverages |
Primary outcome
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.
3 secondary outcomes
Pain assessment
Time frame: approximately 2 hours after surgery
Administered milligram of opioids for pain medication
Time frame: approximately 2 hours after surgery
Postoperative complications in the postanaesthesia care unit
Time frame: approximately 2 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: Undecided. After publications of our data, we plan to share our data in respect of local privacy data laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music via internet and noise canceling headphones and Beverages in people with Postoperative Complications and Postoperative Pain, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Wellbeing (time frame: 1 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.