Preoperative Carefa-MIPANCT06173674
The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety in Older Patients
A study testing Music intervention in people with Preoperative Care and Preoperative Anxiety, run by KU Leuven at 1 site in Belgium.
Trial summary
The goal of this clinical feasibility study is to learn about the acceptability and feasibility of a music intervention in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI) procedure. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Preoperative Care, Preoperative Anxiety
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Dec 2023to 15 Apr 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients being 60 years or older, scheduled for elective cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI);
- being capable and willing to participate in the study.
Who cannot join
- cannot use headphones;
- have a history of music-induced seizures;
- have deafness or severe ear diseases such as acute otitis media, eardrum rupture, tinnitus, ear infections, etc.;
- admitted on the day of cardiac surgery;
- have an expected hospital stay of less than 24 hours or a planned intensive care unit stay postoperatively for longer than one day;
- have severe postoperative complications and are unable to be interviewed;
- are currently diagnosed with major psychiatric disease (such as, major depression, generalized anxiety disorder) and dementia as identified in the history of patients file;
- have pre-operative delirium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety (Fa-MIPA Study) in Older Patients Undergoing Cardiac Surgery or Transcatheter Aortic Valve Implantation (TAVI) Procedure
The goal of this clinical feasibility study is to learn about the acceptability and feasibility of a music intervention in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI) procedure.
The primary question it aims to answer is:
Read more
- What is the feasibility and acceptability of a music intervention to reduce PA in older patients undergoing cardiac surgery and TAVI?
The secondary question is:
- What is the effect of a music intervention on PA levels and the incidence of POD in older patients undergoing cardiac surgery and TAVI?
Participants will
- listen to music before the surgery/TAVI procedure
- be evaluated for preoperative anxiety levels and postoperative delirium
- be interviewed to learn about their perspectives regarding the music intervention
Read the detailed description
Background: High levels of preoperative anxiety (PA) have been associated with several complications, including hemodynamic instability, increased intraoperative requirements for anaesthetics, increased risk of postoperative pain, and in some studies an increased incidence of postoperative delirium (POD). Especially for people with reduced physiological reserves such as older patients, PA can independently heighten the risk of mortality or major morbidity. Music intervention stands out as an effective and practical non-pharmacologic intervention on reducing PA levels. Current evidence has proven the effectiveness of music interventions in reducing preoperative anxiety levels; however, the patients' attitudes, preferences, and overall experience of receiving music intervention before surgery are insufficiently explored. Consequently, the investigation of the acceptability of a music intervention among older patients waiting for surgery or other medical procedures is important, as acceptability has emerged as a pivotal factor in the development, assessment, and implementation of a healthcare intervention. Furthermore, it is essential to assess the feasibility of implementing music intervention within the target population, thereby enhancing the overall acceptability of this intervention.
Objectives: The primary objective is to assess the feasibility and acceptability of a music intervention in reducing PA in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI) procedure. The secondary objective is to test the effect of the music intervention on preoperative anxiety reduction and the incidence of POD in the target population. Moreover, this study will provide reference for the design of a future randomized controlled trial investigating the relationship between PA and POD in older cardiac surgical patients.
Setting: This feasibility study will be conducted in the Department of Cardiology and Department of Cardiovascular Surgery of the University Hospitals Leuven.
Overall methodology: All potential patients will be identified from the list of patients scheduled for surgery or procedure, and they will be assessed for eligibility after agreeing to participate in this study. They will be provided with an information leaflet with the purpose, process, and potential benefits and harms of this study, as well as the commitment to confidentiality and freedom to withdraw at any time without any consequence. Only the patients willing to participate in the study will be further evaluated to determine their adherence to the inclusion/exclusion criteria. For the eligible patients, we will perform the baseline assessment immediately after obtaining written informed consent from patients.
After admission to hospital, patients will receive music intervention before or during surgery/procedure and perioperative routine postoperative care until discharge. We will assess the preoperative anxiety levels of the patient using validated questionnaires at the baseline and after the music intervention, as well as their perspectives regarding the acceptability and feasibility of music intervention via short interview. Any adverse outcomes related to surgery/procedure or music interventions will also be collected.
In light of feasibility nature of our study, a power calculation is deemed unnecessary, and a sufficient sample size of 30-50, accounting for a 20% attrition rate due to short stays before surgery, leads to a planned minimum recruitment of 70 patients. Four trained study nurses will collect the data under the supervision of PhD student and the promotors. All the data will be firstly collected manually by study nurses, and then will be entered and maintained in the Research Electronic Data Capture (REDCap) database.
Descriptive statistics of demographical information, clinical data, and feasibility and acceptability data will be analysed using suitable numerical and graphical summaries for quantitative data. Paired Samples T-Test will be used for preoperative anxiety level changes before and after the music intervention. The difference of incidence of POD between the group with PA reduction and group without PA reduction will be tested using Chi-squared test. The qualitative data will be analyzed using thematic analysis.
- Conditions
- Preoperative Care, Preoperative Anxiety
- Being tested
- Music intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
The music intervention will consist of three components including:
- Playlist composition Six music genres playlists will be offered to patients, including Classical Music, Country Music, Folk Music, Hymns and Reglious Music, Jazz and Swing Music, Popular/Easy Listening/RNB and Soundtrack Music. Patients can also add their favourite music to the list as well.
- Music Intervention Delivery The general criteria for intervention delivery are:1) Each session lasts at least 20 minutes; 2) The music will be delivered by a comfortable, wireless, on/off switch noise-cancelling headphone; 3) The volume will be adjusted according to the patient's preference and controlled at 65dB or lower; 4) The order of music in the playlists will be decided by the patient; 5) Music will be delivered in inpatient room and/or waiting area before surgery/procedure.
- Cleaning and infection of the equipment We will comply with guidelines on disinfection of materials in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Music intervention | Experimental | The music intervention will consist of three components, including 1) playlist composition, 2) music intervention delivery, and 3) cleaning or disinfection of the equipment. Receives: Other: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
The number and proportion of individuals willing to participate will be calculated, and reasons for refusing will be documented.
Measured: Recruitment, on average of 1 day
Compliance rate
The compliance rate refers to one session with 20 minutes or more of music intervention on the day before and on the day of surgery/TAVI procedure.
Measured: from admission to time just before surgery, on average of 2 days
Acceptability of music intervention
Patients perspective regarding their satisfaction and experience of the music intervention will be asked via a short interview (e.g., Overall, were you satisfied with the music listening before your surgery/procedure? Would you like to listen to music again in a future surgery/procedure?)
Measured: After surgery to discharge, on average of 5 days
Patients' preference of music intervention
Patients' preference regarding intervention details including music selection, number of sessions, duration, setting, and implementation time, will be asked via a short interview (e.g., Do you think listening to music 2 times before surgery is enough to reduce anxiety about the surgery/ procedure? When would you prefer to listen to the music?).
Measured: After surgery to discharge, on average of 5 days
Barriers of receiving music intervention
Barriers of receiving music intervention will be also asked (e.g., Did you experience any problems while listening to music?).
Measured: After surgery to discharge, on average of 5 days
Secondary outcomes (5)
Preoperative anxiety levels (APAIS-A)
The preoperative anxiety level will be assessed using the anxiety subscale of Amsterdam Preoperative Anxiety and Information Scale (APAIS-A) before and after receiving the music intervention. APAIS-A consists of 4 items, each of which could be scored from 1 to 5. The score of the APAIS-A is the sum of these four questions, with a scoring range from 4 (not anxious) to 20 (highly anxious).
Measured: from admission to the day of surgery, on average of 2 days
Preoperative anxiety levels (STAI-6)
The preoperative anxiety level will be assessed using six-item Dutch version of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI-6) before and after receiving the music intervention. STAI-6 consists of 6 items, each of which could be scored from 1 (not at all) to 4 (very much so). The sum score varies between 6 and 24, with higher scores indicating higher levels of anxiety.
Measured: from admission to the day of surgery, on average of 2 days
Preoperative anxiety levels (VAS-A)
The preoperative anxiety level will be assessed using VAS-A (Visual Analogue Scale for anxiety) before and after receiving the music intervention. The VAS-A consists of a line which is 10 centimeters in length. Patients are asked to mark a cross on the line based on how they feel during a specified moment in time. A mark at the extreme left end indicates that one feeling not at all anxious. A mark at the extreme right end would indicate that you are feeling the most anxious you could ever imagine.
Measured: from admission to the day of surgery, on average of 2 days
Preoperative anxiety levels (short interview)
We will also ask patients a few questions regarding their changes in overall status and negative thoughts specific to surgery after receiving the music intervention (e.g., Did you feel more relaxed after listening to music before the surgery/procedure?).
Measured: After surgery to discharge, on average of 5 days
Incidence of postoperative delirium
The incidence of postoperative delirium during all postoperative days will be assessed using 3D-CAM (3-Minute Diagnostic Interview for Confusion Assessment Method) and checking patients' records for the results of the Delirium Observations Scale performed by the nurses on the ward. Medical records will also be retrospectively reviewed using CHART-DEL (Chart-based Delirium Identification Instrument) to identify postoperative delirium.
Measured: After surgery to discharge, on average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start4 Dec 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preoperative CareStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Koen Milisen, KU Leuven
- Investigators
- Koen Milisen, PhD, Principal investigator, Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173674
- Sponsor's protocol ID
- S68344
- Acronym
- fa-MIPA
- Status last verified
- Aug 2024
- First submitted
- 20 Nov 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. As far as requests are in line with the scope and research objectives of the fa-MIPA study.
Publications
Yang KL, Detroyer E, Van Grootven B, Tuand K, Zhao DN, Rex S, Milisen K. Association between preoperative anxiety and postoperative delirium in older patients: a systematic review and meta-analysis. BMC Geriatr. 2023 Mar 30;23(1):198. doi: 10.1186/s12877-023-03923-0.
PubMed 36997928Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.
PubMed 29624026Williams JB, Alexander KP, Morin JF, Langlois Y, Noiseux N, Perrault LP, Smolderen K, Arnold SV, Eisenberg MJ, Pilote L, Monette J, Bergman H, Smith PK, Afilalo J. Preoperative anxiety as a predictor of mortality and major morbidity in patients aged >70 years undergoing cardiac surgery. Am J Cardiol. 2013 Jan 1;111(1):137-42. doi: 10.1016/j.amjcard.2012.08.060.
PubMed 23245838Wang R, Huang X, Wang Y, Akbari M. Non-pharmacologic Approaches in Preoperative Anxiety, a Comprehensive Review. Front Public Health. 2022 Apr 11;10:854673. doi: 10.3389/fpubh.2022.854673. eCollection 2022.
PubMed 35480569Aguero-Millan B, Abajas-Bustillo R, Ortego-Mate C. Efficacy of nonpharmacologic interventions in preoperative anxiety: A systematic review of systematic reviews. J Clin Nurs. 2023 Sep;32(17-18):6229-6242. doi: 10.1111/jocn.16755. Epub 2023 May 6.
PubMed 37149743Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
PubMed 23740695
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Acceptability of a Music Intervention to Reduce Preoperative Anxiety (Fa-MIPA Study) in Older Patients Undergoing Cardiac Surgery or Transcatheter Aortic Valve Implantation (TAVI) Procedure
- ClinicalTrials.gov ID
- NCT06173674
- Acronym / sponsor ID
- fa-MIPA / S68344
- Conditions
- Preoperative Care, Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 18 Dec 2023 (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.
The goal of this clinical feasibility study is to learn about the acceptability and feasibility of a music intervention in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI) procedure.
The primary question it aims to answer is:
- What is the feasibility and acceptability of a music intervention to reduce PA in older patients undergoing cardiac surgery and TAVI?
The secondary question is:
- What is the effect of a music intervention on PA levels and the incidence of POD in older patients undergoing cardiac surgery and TAVI?
Participants will
- listen to music before the surgery/TAVI procedure
- be evaluated for preoperative anxiety levels and postoperative delirium
- be interviewed to learn about their perspectives regarding the music intervention
Detailed description
Background: High levels of preoperative anxiety (PA) have been associated with several complications, including hemodynamic instability, increased intraoperative requirements for anaesthetics, increased risk of postoperative pain, and in some studies an increased incidence of postoperative delirium (POD). Especially for people with reduced physiological reserves such as older patients, PA can independently heighten the risk of mortality or major morbidity. Music intervention stands out as an effective and practical non-pharmacologic intervention on reducing PA levels. Current evidence has proven the effectiveness of music interventions in reducing preoperative anxiety levels; however, the patients' attitudes, preferences, and overall experience of receiving music intervention before surgery are insufficiently explored. Consequently, the investigation of the acceptability of a music intervention among older patients waiting for surgery or other medical procedures is important, as acceptability has emerged as a pivotal factor in the development, assessment, and implementation of a healthcare intervention. Furthermore, it is essential to assess the feasibility of implementing music intervention within the target population, thereby enhancing the overall acceptability of this intervention.
Objectives: The primary objective is to assess the feasibility and acceptability of a music intervention in reducing PA in older patients undergoing cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI) procedure. The secondary objective is to test the effect of the music intervention on preoperative anxiety reduction and the incidence of POD in the target population. Moreover, this study will provide reference for the design of a future randomized controlled trial investigating the relationship between PA and POD in older cardiac surgical patients.
Setting: This feasibility study will be conducted in the Department of Cardiology and Department of Cardiovascular Surgery of the University Hospitals Leuven.
Overall methodology: All potential patients will be identified from the list of patients scheduled for surgery or procedure, and they will be assessed for eligibility after agreeing to participate in this study. They will be provided with an information leaflet with the purpose, process, and potential benefits and harms of this study, as well as the commitment to confidentiality and freedom to withdraw at any time without any consequence. Only the patients willing to participate in the study will be further evaluated to determine their adherence to the inclusion/exclusion criteria. For the eligible patients, we will perform the baseline assessment immediately after obtaining written informed consent from patients.
After admission to hospital, patients will receive music intervention before or during surgery/procedure and perioperative routine postoperative care until discharge. We will assess the preoperative anxiety levels of the patient using validated questionnaires at the baseline and after the music intervention, as well as their perspectives regarding the acceptability and feasibility of music intervention via short interview. Any adverse outcomes related to surgery/procedure or music interventions will also be collected.
In light of feasibility nature of our study, a power calculation is deemed unnecessary, and a sufficient sample size of 30-50, accounting for a 20% attrition rate due to short stays before surgery, leads to a planned minimum recruitment of 70 patients. Four trained study nurses will collect the data under the supervision of PhD student and the promotors. All the data will be firstly collected manually by study nurses, and then will be entered and maintained in the Research Electronic Data Capture (REDCap) database.
Descriptive statistics of demographical information, clinical data, and feasibility and acceptability data will be analysed using suitable numerical and graphical summaries for quantitative data. Paired Samples T-Test will be used for preoperative anxiety level changes before and after the music intervention. The difference of incidence of POD between the group with PA reduction and group without PA reduction will be tested using Chi-squared test. The qualitative data will be analyzed using thematic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music intervention | Experimental | Other: Music interventionThe music intervention will consist of three components, including 1) playlist composition, 2) music intervention delivery, and 3) cleaning or disinfection of the equipment. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients being 60 years or older, scheduled for elective cardiac surgery and Transcatheter Aortic Valve Implantation (TAVI);
- being capable and willing to participate in the study.
Key exclusion criteria (8 listed)
- cannot use headphones;
- have a history of music-induced seizures;
- have deafness or severe ear diseases such as acute otitis media, eardrum rupture, tinnitus, ear infections, etc.;
- admitted on the day of cardiac surgery;
- have an expected hospital stay of less than 24 hours or a planned intensive care unit stay postoperatively for longer than one day;
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 interventionThe music intervention will consist of three components including: 1. Playlist composition Six music genres playlists will be offered to patients, including Classical Music, Country Music, Folk Music, Hymns and Reglious Music, Jazz and Swing Music, Popular/Easy Listening/RNB and Soundtrack Music. Patients can also add their favourite music to the list as well. 2. Music Intervention Delivery The general criteria for intervention delivery are:1) Each session lasts at least 20 minutes; 2) The music will be delivered by a comfortable, wireless, on/off switch noise-cancelling headphone; 3) The volume will be adjusted according to the patient's preference and controlled at 65dB or lower; 4) The order of music in the playlists will be decided by the patient; 5) Music will be delivered in inpatient room and/or waiting area before surgery/procedure. 3. Cleaning and infection of the equipment We will comply with guidelines on disinfection of materials in the hospital. | Other | Music intervention |
Primary outcome
Reach
Time frame: Recruitment, on average of 1 day
The number and proportion of individuals willing to participate will be calculated, and reasons for refusing will be documented.
Compliance rate
Time frame: from admission to time just before surgery, on average of 2 days
The compliance rate refers to one session with 20 minutes or more of music intervention on the day before and on the day of surgery/TAVI procedure.
Acceptability of music intervention
Time frame: After surgery to discharge, on average of 5 days
Patients perspective regarding their satisfaction and experience of the music intervention will be asked via a short interview (e.g., Overall, were you satisfied with the music listening before your surgery/procedure? Would you like to listen to music again in a future surgery/procedure?)
Patients' preference of music intervention
Time frame: After surgery to discharge, on average of 5 days
Patients' preference regarding intervention details including music selection, number of sessions, duration, setting, and implementation time, will be asked via a short interview (e.g., Do you think listening to music 2 times before surgery is enough to reduce anxiety about the surgery/ procedure? When would you prefer to listen to the music?).
Barriers of receiving music intervention
Time frame: After surgery to discharge, on average of 5 days
Barriers of receiving music intervention will be also asked (e.g., Did you experience any problems while listening to music?).
5 secondary outcomes
Preoperative anxiety levels (APAIS-A)
Time frame: from admission to the day of surgery, on average of 2 days
Preoperative anxiety levels (STAI-6)
Time frame: from admission to the day of surgery, on average of 2 days
Preoperative anxiety levels (VAS-A)
Time frame: from admission to the day of surgery, on average of 2 days
Preoperative anxiety levels (short interview)
Time frame: After surgery to discharge, on average of 5 days
Incidence of postoperative delirium
Time frame: After surgery to discharge, on average of 5 days
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 22 Aug 2024.
- Background: PubMed 36997928Yang KL, Detroyer E, Van Grootven B, Tuand K, Zhao DN, Rex S, Milisen K. Association between preoperative anxiety and postoperative delirium in older patients: a systematic review and meta-analysis. BMC Geriatr. 2023 Mar 30;23(1):198. doi: 10.1186/s12877-023-03923-0.
- Background: PubMed 29624026Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.
- Background: PubMed 23245838Williams JB, Alexander KP, Morin JF, Langlois Y, Noiseux N, Perrault LP, Smolderen K, Arnold SV, Eisenberg MJ, Pilote L, Monette J, Bergman H, Smith PK, Afilalo J. Preoperative anxiety as a predictor of mortality and major morbidity in patients aged >70 years undergoing cardiac surgery. Am J Cardiol. 2013 Jan 1;111(1):137-42. doi: 10.1016/j.amjcard.2012.08.060.
- Background: PubMed 35480569Wang R, Huang X, Wang Y, Akbari M. Non-pharmacologic Approaches in Preoperative Anxiety, a Comprehensive Review. Front Public Health. 2022 Apr 11;10:854673. doi: 10.3389/fpubh.2022.854673. eCollection 2022.
- Background: PubMed 37149743Aguero-Millan B, Abajas-Bustillo R, Ortego-Mate C. Efficacy of nonpharmacologic interventions in preoperative anxiety: A systematic review of systematic reviews. J Clin Nurs. 2023 Sep;32(17-18):6229-6242. doi: 10.1111/jocn.16755. Epub 2023 May 6.
- Background: PubMed 23740695Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. As far as requests are in line with the scope and research objectives of the fa-MIPA study.
Related trials for Preoperative Care
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Recruiting
Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Gynecologic Cancer Surgery
Prehabilitation, Preoperative Aerobic Training
Recruiting
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Perioperative Care, Intermittent Fasting
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.
Koen Milisen, PhD principal investigator
Department of Public Health and Primary Care, Academic Centre for Nursing and Midwifery, KU Leuven
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 intervention in people with Preoperative Care and Preoperative Anxiety, run by KU Leuven at 1 site in Belgium.
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 2 inclusion and 8 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 22 Aug 2024. 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 Belgium. 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?
Reach (time frame: Recruitment, on average of 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06173674, which also lists 6 linked publications.
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 22 Aug 2024.