Music TherapyNCT05399927
Music as Intervention Nursing in Ambulances
A study testing Music Intervention in people with Music Therapy and Cardiovascular Diseases, run by Universidad Miguel Hernandez de Elche.
Trial summary
Background: Patients with acute cardiovascular disease require out-of-hospital care during the most critical and vulnerable periods of their illness. Objectives: To evaluate the influence of music intervention in patients with an acute cardiovascular condition during their transfer in Advanced Life Support (ALS)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Music Therapy, Cardiovascular Diseases, Critical Care
- What is being tested?
- Music Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Oct 2016
- 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
- be of legal age,
- being aware and oriented in time-space,
- person with signs and symptoms of ACVD transferred in an ALS ambulance for at least 20 minutes.
Who cannot join
- patients with non-physiological bradycardia,
- patients with severe sensory auditory deficiency,
- patients with psychiatric pathology.
About this study
Official title: "Effects of Music Intervention Nursing in Advanced Life Support Ambulances: a Randomised Trial"
Background: Patients with acute cardiovascular disease require out-of-hospital care during the most critical and vulnerable periods of their illness.
Objectives: To evaluate the influence of music intervention in patients with an acute cardiovascular condition during their transfer in Advanced Life Support (ALS) ambulances.
Method: A controlled, randomized experimental analytical study of cases and controls. The intervention group was exposed to relaxing music with sounds from nature. Data related to demographic factors, comorbidities, clinical constants, and drugs administered were gathered. The qualitative variables were summarized using counts and percentages, and the quantitative variables through means and standard deviations.
Read the detailed description
Out-of-hospital Emergency Services are characterized by providing urgent health care, to patients in critical health circumstances, at the place where the event occurs. This fact means that the Advanced Life Support (ALS) ambulances are present when the patient presents a higher degree of stress and, therefore, where greater changes can be found at the physiological level. This is reflected in alterations in the vital signs, which a can increase the pathophysiological effects, as the patient is placed in a hostile and unfamiliar environment, such as the ambulance cabin, surrounded by noises produced by the electromedical equipment and the circumstances of the transport itself (sirens, potholes, speed bumps, …).
In a cabin with these characteristics, the patient may feel claustrophobic, an effect that can be enhanced by the limitation of movement generated by the anchoring of the seat belts to the stretcher and the lack of family support.
The implementation of ALS is relatively young, hence research in this emerging field, has been scarce in scientific production in the discipline of emergencies compared with other specialties in Spain Data were collected with regard to demographic data (age and gender), medical diagnosis, systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), respiratory rate (RR), partial oxygen saturation (SpO2), the concentration of carbon dioxide at the end of exhalation (EtCO2), the pain perceived by means of the visual analog scale (VAS), the bispectral index (BIS) and the temperature (T) every 15 minutes during the transfer.
Data related to administered drugs were also collected, grouped into: antiarrhythmics, antiemetics and opioids. In order to facilitate the collection and recording of data, the nursing report of Castilla La Mancha's Management of Emergencies and Medical Transport (GUETS) has been used, to which the parameters that are not usually collected are routinely added, such as the BIS and EtCO2. For the measurement of vital signs, a manual defibrillator of the Zoll® E-series brand was used. Temperature was recorded with a WelchAllyn brand Sure Temp® PLUS thermometer, the ambient temperature was maintained at around 22-23ºC for comfort. Hypnosis and pain level data were obtained with the BIS VISTA ™ Monitoring System.
The music system used was a BTS dynamic mini speaker, model MS109. The decibels were measured in the passenger cabin during the transfer, being in a range of 48.6 - 59.5 dB reaching a maximum of 73.1 dB when driving over a speed bump, and a maximum of 77.7 dB when putting on the sirens. Consequently, the volume was adjusted between 65-70 dB, to mask the usual sounds of the cabin.
The qualitative variables have been summarized using counts and percentages. The mean and standard deviation were used to summarize the quantitative variables. The Kolmogorov-Smirnov test was employed to verify the hypothesis of normality. Depending on the test result, a parametric test (t test for two independent samples) or a non-parametric test (Mann-Whitney U test) was used. For qualitative variables, the Chi-square test or Fisher's exact test were used according to the fulfillment of the approximation conditions. An adjusted multivariate logistic regression model was used to try to characterize the patients in each of the groups considered. For its construction, those variables that presented a p-value <0.10 in the univariate study have been considered. The ODDS Ratio and its corresponding 95% confidence interval were calculated. To validate the model, the Hosmer and Lemeshow (HL) goodness of fit test was performed. Nagelkerke's R2 coefficient was used to estimate the proportion of the explained variance. The precision of the model was evaluated using the area under the curve (AUC). A p-value of less than 0.05 was considered significant. The analyses were performed with the IBM SPSS v25 statistical package.
- Conditions
- Music Therapy, Cardiovascular Diseases, Critical Care, Emergencies
- Being tested
- Music Intervention
- Keywords
- Cardiovascular Disease, Music Therapy, Emergency Mobile Unit, Critical Care Nursing, Statistical comparison.
- Medical subject headings
- Cardiovascular Diseases, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music InterventionOther
Also called Music Therapy
The objective of this study is to observe the effects that music produces on physiological parameters, in patients with Acute Cardiovascular Disease (ACVD), and to determine its influence on the types or doses of drugs administered during initial care. The intervention study is carried out in the ambulance cabin during the time of transfer to the destination Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group underwent exposure to relaxing music with sounds from nature Receives: Other: Music Intervention |
| Control | No intervention | The control group under the usual transfer conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SBP
Systolic Blood Pressure (mm Hg)
Measured: 20 minutes
DBP
Diastolic Blood Pressure (mm Hg)
Measured: 20 minutes
HR
Heart Rate (beats per minute)
Measured: 20 minutes
RR
Respiratory Rate (breaths per minute)
Measured: 20 minutes
SpO2
Oxigen Saturation (%)
Measured: 20 minutes
EtCO2
Exhaled Carbon Dioxide (%)
Measured: 20 minutes
VAS
Visual Analog Scale (0 to 10): 0 no pain; 1-2 slight pain; 3-4 mild pain; 5-6 moderate pain; 7-8 severe pain and 10 horrible pain.
Measured: 20 minutes
BIS
Bispectral Index (0 to 100) :0 flat-line EEG; 0-40 Deep hypnotic state; 41-60 anesthesia range; 61-90 sedation range; 91-100 awake.
Measured: 20 minutes
Secondary outcomes (8)
Nitrates/Antiarrhythmics
drugs administered transfer (Yes/No)
Measured: up to 4 hours
Opioids
drugs administered transfer (Yes/No)
Measured: up to 4 hours
Antiemetics
drugs administered transfer (Yes/No)
Measured: up to 4 hours
Benzodiazepines
drugs administered transfer (Yes/No)
Measured: up to 4 hours
Tenecteplase
drugs administered transfer (Yes/No)
Measured: up to 4 hours
Enoxoparin
drugs administered transfer (Yes/No)
Measured: up to 4 hours
Furosemide
drugs administered transfer (Yes/No)
Measured: up to 4 hours
Ranitidine
drugs administered transfer (Yes/No)
Measured: up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study startJul 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Ángeles Gregorio Sanz, Universidad Miguel Hernandez de Elche
- Investigators
- MARIA ANGELES GREGORIO-SANZ, Master, Principal investigator, UNIVERSIDAD MIGUEL HERNANDEZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399927
- Sponsor's protocol ID
- 23UMH
- Status last verified
- Dec 2022
- First submitted
- 26 Mar 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
PubMed 26277246do Amaral MA, Neto MG, de Queiroz JG, Martins-Filho PR, Saquetto MB, Oliveira Carvalho V. Effect of music therapy on blood pressure of individuals with hypertension: A systematic review and Meta-analysis. Int J Cardiol. 2016 Jul 1;214:461-4. doi: 10.1016/j.ijcard.2016.03.197. Epub 2016 Apr 3.
PubMed 27096963Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
PubMed 29665028Heidari S, Babaii A, Abbasinia M, Shamali M, Abbasi M, Rezaei M. The Effect of Music on Anxiety and Cardiovascular Indices in Patients Undergoing Coronary Artery Bypass Graft: A Randomized Controlled Trial. Nurs Midwifery Stud. 2015 Dec;4(4):e31157. doi: 10.17795/nmsjournal31157. Epub 2015 Dec 1.
PubMed 26835471McClurkin SL, Smith CD. The Duration of Self-Selected Music Needed to Reduce Preoperative Anxiety. J Perianesth Nurs. 2016 Jun;31(3):196-208. doi: 10.1016/j.jopan.2014.05.017. Epub 2016 Feb 24.
PubMed 27235956Chang HK, Peng TC, Wang JH, Lai HL. Psychophysiological responses to sedative music in patients awaiting cardiac catheterization examination: a randomized controlled trial. J Cardiovasc Nurs. 2011 Sep-Oct;26(5):E11-8. doi: 10.1097/JCN.0b013e3181fb711b.
PubMed 21372737Ng MY, Karimzad Y, Menezes RJ, Wintersperger BJ, Li Q, Forero J, Paul NS, Nguyen ET. Randomized controlled trial of relaxation music to reduce heart rate in patients undergoing cardiac CT. Eur Radiol. 2016 Oct;26(10):3635-42. doi: 10.1007/s00330-016-4215-8. Epub 2016 Jan 27.
PubMed 26817929Tam WW, Lo KK, Hui DS. The effect of music during bronchoscopy: A meta-analysis. Heart Lung. 2016 Mar-Apr;45(2):86-94. doi: 10.1016/j.hrtlng.2015.12.004. Epub 2016 Jan 4.
PubMed 26764267Bradt J, Dileo C, Potvin N. Music for stress and anxiety reduction in coronary heart disease patients. Cochrane Database Syst Rev. 2013 Dec 28;2013(12):CD006577. doi: 10.1002/14651858.CD006577.pub3.
PubMed 24374731Liang Z, Ren D, Choi J, Happ MB, Hravnak M, Hoffman LA. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial. Complement Ther Med. 2016 Dec;29:72-77. doi: 10.1016/j.ctim.2016.09.003. Epub 2016 Sep 15.
PubMed 27912960Maeyama A, Kodaka M, Miyao H. [Effect of the music-therapy under spinal anesthesia]. Masui. 2009 Jun;58(6):684-91. Japanese.
PubMed 19522258Gramaglia C, Gambaro E, Vecchi C, Licandro D, Raina G, Pisani C, Burgio V, Farruggio S, Rolla R, Deantonio L, Grossini E, Krengli M, Zeppegno P. Outcomes of music therapy interventions in cancer patients-A review of the literature. Crit Rev Oncol Hematol. 2019 Jun;138:241-254. doi: 10.1016/j.critrevonc.2019.04.004. Epub 2019 Apr 5.
PubMed 31121392Sanjuan Navais M, Via Clavero G, Vazquez Guillamet B, Moreno Duran AM, Martinez Estalella G. [Effect of music on anxiety and pain in patients with mechanical ventilation]. Enferm Intensiva. 2013 Apr-Jun;24(2):63-71. doi: 10.1016/j.enfi.2012.11.003. Epub 2013 Jan 5. Spanish.
PubMed 23298702
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effects of Music Intervention Nursing in Advanced Life Support Ambulances: a Randomised Trial"
- ClinicalTrials.gov ID
- NCT05399927
- Acronym / sponsor ID
- 23UMH
- Conditions
- Music Therapy, Cardiovascular Diseases, Critical Care, Emergencies
- Keywords
- Cardiovascular Disease, Music Therapy, Emergency Mobile Unit, Critical Care Nursing, Statistical comparison.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Jun 2022 (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.
Background: Patients with acute cardiovascular disease require out-of-hospital care during the most critical and vulnerable periods of their illness.
Objectives: To evaluate the influence of music intervention in patients with an acute cardiovascular condition during their transfer in Advanced Life Support (ALS) ambulances.
Method: A controlled, randomized experimental analytical study of cases and controls. The intervention group was exposed to relaxing music with sounds from nature. Data related to demographic factors, comorbidities, clinical constants, and drugs administered were gathered. The qualitative variables were summarized using counts and percentages, and the quantitative variables through means and standard deviations.
Detailed description
Out-of-hospital Emergency Services are characterized by providing urgent health care, to patients in critical health circumstances, at the place where the event occurs. This fact means that the Advanced Life Support (ALS) ambulances are present when the patient presents a higher degree of stress and, therefore, where greater changes can be found at the physiological level. This is reflected in alterations in the vital signs, which a can increase the pathophysiological effects, as the patient is placed in a hostile and unfamiliar environment, such as the ambulance cabin, surrounded by noises produced by the electromedical equipment and the circumstances of the transport itself (sirens, potholes, speed bumps, …).
In a cabin with these characteristics, the patient may feel claustrophobic, an effect that can be enhanced by the limitation of movement generated by the anchoring of the seat belts to the stretcher and the lack of family support.
The implementation of ALS is relatively young, hence research in this emerging field, has been scarce in scientific production in the discipline of emergencies compared with other specialties in Spain Data were collected with regard to demographic data (age and gender), medical diagnosis, systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), respiratory rate (RR), partial oxygen saturation (SpO2), the concentration of carbon dioxide at the end of exhalation (EtCO2), the pain perceived by means of the visual analog scale (VAS), the bispectral index (BIS) and the temperature (T) every 15 minutes during the transfer.
Data related to administered drugs were also collected, grouped into: antiarrhythmics, antiemetics and opioids. In order to facilitate the collection and recording of data, the nursing report of Castilla La Mancha's Management of Emergencies and Medical Transport (GUETS) has been used, to which the parameters that are not usually collected are routinely added, such as the BIS and EtCO2. For the measurement of vital signs, a manual defibrillator of the Zoll® E-series brand was used. Temperature was recorded with a WelchAllyn brand Sure Temp® PLUS thermometer, the ambient temperature was maintained at around 22-23ºC for comfort. Hypnosis and pain level data were obtained with the BIS VISTA ™ Monitoring System.
The music system used was a BTS dynamic mini speaker, model MS109. The decibels were measured in the passenger cabin during the transfer, being in a range of 48.6 - 59.5 dB reaching a maximum of 73.1 dB when driving over a speed bump, and a maximum of 77.7 dB when putting on the sirens. Consequently, the volume was adjusted between 65-70 dB, to mask the usual sounds of the cabin.
The qualitative variables have been summarized using counts and percentages. The mean and standard deviation were used to summarize the quantitative variables. The Kolmogorov-Smirnov test was employed to verify the hypothesis of normality. Depending on the test result, a parametric test (t test for two independent samples) or a non-parametric test (Mann-Whitney U test) was used. For qualitative variables, the Chi-square test or Fisher's exact test were used according to the fulfillment of the approximation conditions. An adjusted multivariate logistic regression model was used to try to characterize the patients in each of the groups considered. For its construction, those variables that presented a p-value <0.10 in the univariate study have been considered. The ODDS Ratio and its corresponding 95% confidence interval were calculated. To validate the model, the Hosmer and Lemeshow (HL) goodness of fit test was performed. Nagelkerke's R2 coefficient was used to estimate the proportion of the explained variance. The precision of the model was evaluated using the area under the curve (AUC). A p-value of less than 0.05 was considered significant. The analyses were performed with the IBM SPSS v25 statistical package.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Music InterventionThe intervention group underwent exposure to relaxing music with sounds from nature |
| Control | No intervention | –The control group under the usual transfer conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be of legal age,
- being aware and oriented in time-space,
- person with signs and symptoms of ACVD transferred in an ALS ambulance for at least 20 minutes.
Key exclusion criteria (3 listed)
- patients with non-physiological bradycardia,
- patients with severe sensory auditory deficiency,
- patients with psychiatric pathology.
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 InterventionAlso: Music TherapyThe objective of this study is to observe the effects that music produces on physiological parameters, in patients with Acute Cardiovascular Disease (ACVD), and to determine its influence on the types or doses of drugs administered during initial care. The intervention study is carried out in the ambulance cabin during the time of transfer to the destination Hospital. | Other | Intervention |
Primary outcome
SBP
Time frame: 20 minutes
Systolic Blood Pressure (mm Hg)
DBP
Time frame: 20 minutes
Diastolic Blood Pressure (mm Hg)
HR
Time frame: 20 minutes
Heart Rate (beats per minute)
RR
Time frame: 20 minutes
Respiratory Rate (breaths per minute)
SpO2
Time frame: 20 minutes
Oxigen Saturation (%)
EtCO2
Time frame: 20 minutes
Exhaled Carbon Dioxide (%)
VAS
Time frame: 20 minutes
Visual Analog Scale (0 to 10): 0 no pain; 1-2 slight pain; 3-4 mild pain; 5-6 moderate pain; 7-8 severe pain and 10 horrible pain.
BIS
Time frame: 20 minutes
Bispectral Index (0 to 100) :0 flat-line EEG; 0-40 Deep hypnotic state; 41-60 anesthesia range; 61-90 sedation range; 91-100 awake.
8 secondary outcomes
Nitrates/Antiarrhythmics
Time frame: up to 4 hours
Opioids
Time frame: up to 4 hours
Antiemetics
Time frame: up to 4 hours
Benzodiazepines
Time frame: up to 4 hours
Tenecteplase
Time frame: up to 4 hours
Enoxoparin
Time frame: up to 4 hours
Furosemide
Time frame: up to 4 hours
Ranitidine
Time frame: up to 4 hours
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 12 Dec 2022.
- Background: PubMed 26277246Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
- Background: PubMed 27096963do Amaral MA, Neto MG, de Queiroz JG, Martins-Filho PR, Saquetto MB, Oliveira Carvalho V. Effect of music therapy on blood pressure of individuals with hypertension: A systematic review and Meta-analysis. Int J Cardiol. 2016 Jul 1;214:461-4. doi: 10.1016/j.ijcard.2016.03.197. Epub 2016 Apr 3.
- Background: PubMed 29665028Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
- Background: PubMed 26835471Heidari S, Babaii A, Abbasinia M, Shamali M, Abbasi M, Rezaei M. The Effect of Music on Anxiety and Cardiovascular Indices in Patients Undergoing Coronary Artery Bypass Graft: A Randomized Controlled Trial. Nurs Midwifery Stud. 2015 Dec;4(4):e31157. doi: 10.17795/nmsjournal31157. Epub 2015 Dec 1.
- Background: PubMed 27235956McClurkin SL, Smith CD. The Duration of Self-Selected Music Needed to Reduce Preoperative Anxiety. J Perianesth Nurs. 2016 Jun;31(3):196-208. doi: 10.1016/j.jopan.2014.05.017. Epub 2016 Feb 24.
- Background: PubMed 21372737Chang HK, Peng TC, Wang JH, Lai HL. Psychophysiological responses to sedative music in patients awaiting cardiac catheterization examination: a randomized controlled trial. J Cardiovasc Nurs. 2011 Sep-Oct;26(5):E11-8. doi: 10.1097/JCN.0b013e3181fb711b.
- Background: PubMed 26817929Ng MY, Karimzad Y, Menezes RJ, Wintersperger BJ, Li Q, Forero J, Paul NS, Nguyen ET. Randomized controlled trial of relaxation music to reduce heart rate in patients undergoing cardiac CT. Eur Radiol. 2016 Oct;26(10):3635-42. doi: 10.1007/s00330-016-4215-8. Epub 2016 Jan 27.
- Background: PubMed 26764267Tam WW, Lo KK, Hui DS. The effect of music during bronchoscopy: A meta-analysis. Heart Lung. 2016 Mar-Apr;45(2):86-94. doi: 10.1016/j.hrtlng.2015.12.004. Epub 2016 Jan 4.
- Background: PubMed 24374731Bradt J, Dileo C, Potvin N. Music for stress and anxiety reduction in coronary heart disease patients. Cochrane Database Syst Rev. 2013 Dec 28;2013(12):CD006577. doi: 10.1002/14651858.CD006577.pub3.
- Background: PubMed 27912960Liang Z, Ren D, Choi J, Happ MB, Hravnak M, Hoffman LA. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial. Complement Ther Med. 2016 Dec;29:72-77. doi: 10.1016/j.ctim.2016.09.003. Epub 2016 Sep 15.
- Background: PubMed 19522258Maeyama A, Kodaka M, Miyao H. [Effect of the music-therapy under spinal anesthesia]. Masui. 2009 Jun;58(6):684-91. Japanese.
- Background: PubMed 31121392Gramaglia C, Gambaro E, Vecchi C, Licandro D, Raina G, Pisani C, Burgio V, Farruggio S, Rolla R, Deantonio L, Grossini E, Krengli M, Zeppegno P. Outcomes of music therapy interventions in cancer patients-A review of the literature. Crit Rev Oncol Hematol. 2019 Jun;138:241-254. doi: 10.1016/j.critrevonc.2019.04.004. Epub 2019 Apr 5.
- Individual participant dataSharing planned: No
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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.
MARIA ANGELES GREGORIO-SANZ, Master principal investigator
UNIVERSIDAD MIGUEL HERNANDEZ
Questions about this trial
What is this clinical trial studying?
A study testing Music Intervention in people with Music Therapy and Cardiovascular Diseases, run by Universidad Miguel Hernandez de Elche.
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 3 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
SBP (time frame: 20 minutes). The study lists 8 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 NCT05399927, which also lists 13 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 12 Dec 2022.