Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03882541
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2018-11-28
Brief Title:
Could Music be an Alternative to Sedation in Patients Treated Total Knee Arthroplasty With Regional Anesthesia
Sponsor:
Consorci Sanitari de lAnoia
Organization:
Consorci Sanitari de lAnoia
Study Overview
Official Title:
Could Music be an Alternative to Sedation in Patients Treated Total Knee Arthroplasty With Regional Anesthesia A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Anxiety is a common phenomenon in hospitalized patients In order to reduce it during the surgical procedure sedatives and anxiolytics are used which can cause undesirable side effects for patients Music is described as an effective tool to reduce this anxiety suffered by the patient in the perioperative process
Objectives To evaluate the effect of music in patients anxiety and pain during perioperative process in surgical intervention with regional anaesthesia without sedatives or anxiolytics
Design A randomized parallel clinical trial study with single-blinded and three harms
Setting Operating theater of a public district hospital serving around 111000 people Participants All patients operated of Total Knee Arthroplasty TKA with regional anaesthesia with age between 50 and 85 years old within level I or II of the classification of the American Society of Anaesthesiologists ASA
Methods A total of 81 patients for TKA were randomly assigned to a control group headphones without music without sedation a sedative group headphones without music with sedation and a experimental group headphones with music without sedation 27 participants for each group All the participants were using headphones so that it was a single-blinded study The experimental group were provided with the same music Piano Guys group The variables of study were the pain was measured by vale numerical scale VNS the anxiety was measured by the use of State-Trait Anxiety Inventory STAI heart rate HR variability blood pressure BP variability saturation of oxygen Sat02
Relevance to Clinical Practice sedation that can causes unwanted side effects by surgical patients can be replaced by music The music decrease anxiety and pain values in orthopaedic surgery patients
Keywords Anxiety Drugs Music therapy Pain Perioperative Surgery
Objectives To evaluate the effect of music in patients anxiety and pain during perioperative process in surgical intervention with regional anaesthesia without sedatives or anxiolytics
Design A randomized parallel clinical trial study with single-blinded and three harms
Setting Operating theater of a public district hospital serving around 111000 people Participants All patients operated of Total Knee Arthroplasty TKA with regional anaesthesia with age between 50 and 85 years old within level I or II of the classification of the American Society of Anaesthesiologists ASA
Methods A total of 81 patients for TKA were randomly assigned to a control group headphones without music without sedation a sedative group headphones without music with sedation and a experimental group headphones with music without sedation 27 participants for each group All the participants were using headphones so that it was a single-blinded study The experimental group were provided with the same music Piano Guys group The variables of study were the pain was measured by vale numerical scale VNS the anxiety was measured by the use of State-Trait Anxiety Inventory STAI heart rate HR variability blood pressure BP variability saturation of oxygen Sat02
Relevance to Clinical Practice sedation that can causes unwanted side effects by surgical patients can be replaced by music The music decrease anxiety and pain values in orthopaedic surgery patients
Keywords Anxiety Drugs Music therapy Pain Perioperative Surgery
Detailed Description:
1 Introduction Patients generally experience high levels of anxiety when are hospitalized to undergo surgery and other invasive procedures Anxiety is an emotional state or condition characterized by stress and unpleasant feelings Awake patients in the operating theatre are afraid of they will feel pain during the surgical andor regional anaesthetic procedures which contributes to increased anxiety Patients operated under regional anaesthesia are in particular need of sedation during the perioperative period The purpose of the sedation is to ensure comfort full cooperation and cardiovascular stability of patients who can maintain a patent airway However because of the adverse effects respiratory depression nausea vomiting optimal patient satisfaction is hard to achieve Additionally intraoperative anxiety is often associated with a greater incidence of pain after surgery
On the other hand toxicity of general anaesthetics has been recently studied from its neurotoxic effect to neuroapoptosis In some cases they may cause postoperative cognitive dysfunction and other side effects known as hypoxemia respiratory depression and increased morbidity and mortality
Music has been suggested as a potential intervention to reduce anxiety and pain in the operating room environment Systematic meta-analysis conducted by Nilsson revealed that 50 of studies 12 of 24 published between January 1995-January 2007 found significant reductions in anxiety scores as measured by STAI and then more studies have been carried out on the benefits of music which have continued to show that music reduces preoperative and postoperative anxiety and also reduces postoperative pain
There are also studies that conclude that patients to listening music require less midazolam to achieve a similar degree of relaxation as controls in ambulatory surgery patients and that the relaxing music a useful alternative to midazolam for pre-medication before surgery
Music holds considerable promise as an adjuvant pain management therapy and in mild cases may be used to supplement perhaps even replace pharmaceutical interventions before during and after painful procedures The maximal reduction in pain intensity levels is 09 units on a zero to ten scale although this difference reaches statistical significance its clinical importance is unclear
The aim of this study was to evaluate the effect of the use of music in the perioperative process of patients undergoing surgery of total knee arthroplasty with regional anaesthesia without sedatives and compare anxiety and pain of these patients operated with regional anaesthesia listening to or not music through headphones in patients without sedation
2 Material and methods 21 Research design and setting This study was a randomized clinical trial study with single-blind three harms and parallel that took place in the operating theatre conducted from January 2017 to January 2018
The participants who had the signed informed consent once they reached the surgical area were divided into the three groups according to the randomization list control group headphones without music without sedation sedation group headphones without music with sedation intervention group headphones with music without sedation
Ninety-five patients were eligible for the purpose of this study and ten were refused to participate in the study From the 85 remaining subjects 29 were allocated to the control group 27 to the sedation group while 29 were allocated to the intervention group The CONSORT flow diagram of the progress through the phases of a parallel randomised trial of the three groups is shown on Figure 1
There were not changes to methods after trial commencement
22 Participants and Sample size The study was performed on participants scheduled for a Total Knee Arthroplasty procedure in a Public Hospital from January 2017 to January 2018 The inclusion criteria were 1 age with a range from 50 to 85 years old 2 had regional anaesthesia 3 duration of surgery not exceeding two hours 4 was willing to participate in the study and signed an informed consent form The exclusion criteria were 1 those patients with classification system of American Society of Anaesthesiologists ASA 3 or 4 2 allergic drugs used 3 psychiatric patients or cognitive issues 4 patients with whom we have communication problems 5 patients who for any reason need another type of anaesthesia
Sample size was determinate regarding the possible differences in the value of numerical pain among the 3 groups studied Thus in an analysis of the variance of a three-level factor ANOVA assuming a common standard deviation of 15 and a minimum difference to detect of 1 point or equivalent to detect a difference in any quantitative variable of 066 standard deviations with a statistical power of 80 and an alpha error of 005 53 patients were needed in each of the three groups to detect the difference as statistically significant A maximum 10 follow-up loss was considered The result of the sample was 159 participants An interim analysis was carried out that according to the statistical calculation had to be carried out when arriving at 81 participants 27 for each group If the result was significant beneficial or harmful compared to the concurrent placebo group the study could be stopped
23 Randomization Randomization lists were generated based on pseudorandom numbers with the SPSS program For the study 3 blocks of 81 patients each were performed corresponding to 27 patients for each group
All randomization was independent of the researches Randomization was done by a statistician who was not part of the data analysis
When a participant was a candidate to participate in the study the random allocation table was consulted when the group was assigned the researchers elaborated a closed envelope with information on the intervention received with or without sedation and with or without music by the participant in case it was It is necessary to break the simple blind They were also told to the participants that they would not say whether or not they would listen to music
The staff personnel and the assistants to the investigation were blinded to the participants group assignment
24 Intervention Once the participants were included in the study they were assigned a group according to the randomization table The participants of the control group were placed with headphones that no produced music and were administered 2 ml of serum participants in the sedation group were placed with headphones without music and were administered the corresponding dose of midazolam 0025 mg kg in patients under 65 years of age In patients over 65 years of age and or with hepatic insufficiency or renal insufficiency with glomerular filtration 30 ml h the dose of midazolam was 0015 mg Kg and the participants of the intervention group were placed with headphones that produced music and were administered 2 ml of serum All the participants were administered the same anaesthetic levobupivacaine for regional anaesthesia and the same analgesics in the postoperative period ropivacaine dexketeroprofen paracetamol A standardization of anaesthesia and analgesia was performed by the anaesthesiology and resuscitation service of the hospital
The music that the groups patients listened to during their stay in the operating theatre was a collection of songs from the music group Piano Guys played a volume of 50-55 db The headphone used were Audio-Technica ATH-M40X and the mp3 was iPod Nano Apple
According to some studies it is recommended that therapeutic music should have a slow tempo low pitch regular rhythm and pleasing harmonics and should consist of string flute and piano selections Nilsson 2008 Pelletier 2004 In a Cochrane review the genre and the duration of the soothing music did not seem to influence the effectiveness of music intervention
There were not any changes to trial outcomes after the trial commenced
25 Instruments and Measurements We employed both subjective and objective measures for anxiety and pain in our study
251 State-Trait Anxiety Inventory STAI The State-Trait Anxiety Inventory STAI consists of two different parts termed STAI-Trait Anxiety Inventory STAI-TA and STAI-State Anxiety Inventory STAI-SA This test requires patients to complete a 40-item 20 items measuring state anxiety and 20 items measuring trait anxiety Spielberger et al1970 adding each one of the items of each subscale The score can range between 0 and 60 representing the highest and lowest levels of anxiety respectively In our study STAI-TA test results were evaluated preoperatively The STAI-SA was performed during the waiting room Orthopaedic unit 30 minutes before surgery and postoperative period in Post anaesthesia care unit PACU recovery period 30 minutes after surgery There are no cut points but direct scores are transformed into centiles based on sex and age
252 Vale Numerical Scale VNS Pain intensity is frequently measured for visual analogue scale VAS or numerical ranting scale NRS We used the NRS pain was assessed on a 10-point pain intensity numerical rating scale where 0no pain and 10worst possible pain Lee et al2015 The researcher gave oral instruction of Please said the point at the number to show how much pain do you have right now The pain was measured in preoperative intraoperative and postoperative phase
253 Hemodynamic constants To measure HR and BP the researchers placed the sensor on the radial area of the patients forearm for 15 minutes Monitoring of the electrocardiogram ECG and capillary oxygen saturation SatO2 was continuous The participants were asked not to move around to ensure the quality of the readings In our study HR BP and SatO2 was measured by a Datex Ohmeda TYPE D-LCC1503
26 Data collection process This research was approved by the Ethical Committee for Clinical Research approved code PR21816
The researchers SR MR checked the operating schedule and met potential participants in the room of orthopaedic unit where we take the signed consent and we gave them the STAI questionnaire
When the participants reached preoperative area the researchers looked the group that belonged to each participant according to randomization list and they were monitored hemodynamic constants HR BP SatO2 the headphones were placed with or without music and the dose of sedation or physiological serum placebo was administrated according to the study group to which they belonged The dose of sedation or serum was repeated every 45 minutes until surgery was finished All the data STAI preoperative and postoperative VNS preoperative and postoperative hemodynamic constants every 15 minutes dose anaesthetics and analgesics sociodemographic variables were registered in a graph created by researchers
The data collection in each phase preoperative intraoperative and postoperative was carried out by nurses who did not belong to the research team who were educated before starting the study so that there were no biases in the collection
27 Statistical analysis Categorical variables were described by means of the number of cases the percentage with respect to the total by category and the number of available data Continuous variables were described by means of the number of cases the mean and the standard deviation or the median and the inter-quartile range IQR Continuous variables were compared using Students t-test or Mann-Whitney U-test as appropriate Fishers exact test or Pearsons χ2 test were applied to assess the relationship between categorical variables In order to evaluate the main objective a covariance analysis was performed to evaluate the role of the intervention in the change in the value of the final pain compared to initial pain The effects of each intervention were compared by pairs with the adjustment for multiple comparisons of Tukey The rest of the study variables STAI questionnaire and hemodynamic constants BP HR SatO2 were analysed similarly Models were replicated adjusted by age and gender Analyses were performed with R software 340 The statistical significance was set at a probability level 005
28 Ethical considerations The participants who met the inclusion criteria were informed by the researchers and they were also given an informative document of the study The participants who wanted to participate in the study signed an informed consent
41 Limitations When we performed the post-STAI test in the Post Anesthesia Care Unit PACU some patients could not read the questionnaire because they did not have the glasses so the nurse had to ask the questions In future studies a better research design or a more suitable testing location can provide a better understanding on this subject Additional research could examine the effectiveness of listening to preferred music the use of music as an alternative to another type of sedative drug such as propofol for other surgical patients as well as their satisfaction
Conflict of interest and Funding None Acknowledgements The authors thanks all professionals who have collaborated in the study surgery nurses nursing traumatology department and nursing supervision
Thanks especially Dr Xavier Pelfort and Dr Joan Miquel for assistance with study design statistical analysis manuscript review and anaesthetist Dr Josep Mª Bausili for assistance with anaesthesia standardization
On the other hand toxicity of general anaesthetics has been recently studied from its neurotoxic effect to neuroapoptosis In some cases they may cause postoperative cognitive dysfunction and other side effects known as hypoxemia respiratory depression and increased morbidity and mortality
Music has been suggested as a potential intervention to reduce anxiety and pain in the operating room environment Systematic meta-analysis conducted by Nilsson revealed that 50 of studies 12 of 24 published between January 1995-January 2007 found significant reductions in anxiety scores as measured by STAI and then more studies have been carried out on the benefits of music which have continued to show that music reduces preoperative and postoperative anxiety and also reduces postoperative pain
There are also studies that conclude that patients to listening music require less midazolam to achieve a similar degree of relaxation as controls in ambulatory surgery patients and that the relaxing music a useful alternative to midazolam for pre-medication before surgery
Music holds considerable promise as an adjuvant pain management therapy and in mild cases may be used to supplement perhaps even replace pharmaceutical interventions before during and after painful procedures The maximal reduction in pain intensity levels is 09 units on a zero to ten scale although this difference reaches statistical significance its clinical importance is unclear
The aim of this study was to evaluate the effect of the use of music in the perioperative process of patients undergoing surgery of total knee arthroplasty with regional anaesthesia without sedatives and compare anxiety and pain of these patients operated with regional anaesthesia listening to or not music through headphones in patients without sedation
2 Material and methods 21 Research design and setting This study was a randomized clinical trial study with single-blind three harms and parallel that took place in the operating theatre conducted from January 2017 to January 2018
The participants who had the signed informed consent once they reached the surgical area were divided into the three groups according to the randomization list control group headphones without music without sedation sedation group headphones without music with sedation intervention group headphones with music without sedation
Ninety-five patients were eligible for the purpose of this study and ten were refused to participate in the study From the 85 remaining subjects 29 were allocated to the control group 27 to the sedation group while 29 were allocated to the intervention group The CONSORT flow diagram of the progress through the phases of a parallel randomised trial of the three groups is shown on Figure 1
There were not changes to methods after trial commencement
22 Participants and Sample size The study was performed on participants scheduled for a Total Knee Arthroplasty procedure in a Public Hospital from January 2017 to January 2018 The inclusion criteria were 1 age with a range from 50 to 85 years old 2 had regional anaesthesia 3 duration of surgery not exceeding two hours 4 was willing to participate in the study and signed an informed consent form The exclusion criteria were 1 those patients with classification system of American Society of Anaesthesiologists ASA 3 or 4 2 allergic drugs used 3 psychiatric patients or cognitive issues 4 patients with whom we have communication problems 5 patients who for any reason need another type of anaesthesia
Sample size was determinate regarding the possible differences in the value of numerical pain among the 3 groups studied Thus in an analysis of the variance of a three-level factor ANOVA assuming a common standard deviation of 15 and a minimum difference to detect of 1 point or equivalent to detect a difference in any quantitative variable of 066 standard deviations with a statistical power of 80 and an alpha error of 005 53 patients were needed in each of the three groups to detect the difference as statistically significant A maximum 10 follow-up loss was considered The result of the sample was 159 participants An interim analysis was carried out that according to the statistical calculation had to be carried out when arriving at 81 participants 27 for each group If the result was significant beneficial or harmful compared to the concurrent placebo group the study could be stopped
23 Randomization Randomization lists were generated based on pseudorandom numbers with the SPSS program For the study 3 blocks of 81 patients each were performed corresponding to 27 patients for each group
All randomization was independent of the researches Randomization was done by a statistician who was not part of the data analysis
When a participant was a candidate to participate in the study the random allocation table was consulted when the group was assigned the researchers elaborated a closed envelope with information on the intervention received with or without sedation and with or without music by the participant in case it was It is necessary to break the simple blind They were also told to the participants that they would not say whether or not they would listen to music
The staff personnel and the assistants to the investigation were blinded to the participants group assignment
24 Intervention Once the participants were included in the study they were assigned a group according to the randomization table The participants of the control group were placed with headphones that no produced music and were administered 2 ml of serum participants in the sedation group were placed with headphones without music and were administered the corresponding dose of midazolam 0025 mg kg in patients under 65 years of age In patients over 65 years of age and or with hepatic insufficiency or renal insufficiency with glomerular filtration 30 ml h the dose of midazolam was 0015 mg Kg and the participants of the intervention group were placed with headphones that produced music and were administered 2 ml of serum All the participants were administered the same anaesthetic levobupivacaine for regional anaesthesia and the same analgesics in the postoperative period ropivacaine dexketeroprofen paracetamol A standardization of anaesthesia and analgesia was performed by the anaesthesiology and resuscitation service of the hospital
The music that the groups patients listened to during their stay in the operating theatre was a collection of songs from the music group Piano Guys played a volume of 50-55 db The headphone used were Audio-Technica ATH-M40X and the mp3 was iPod Nano Apple
According to some studies it is recommended that therapeutic music should have a slow tempo low pitch regular rhythm and pleasing harmonics and should consist of string flute and piano selections Nilsson 2008 Pelletier 2004 In a Cochrane review the genre and the duration of the soothing music did not seem to influence the effectiveness of music intervention
There were not any changes to trial outcomes after the trial commenced
25 Instruments and Measurements We employed both subjective and objective measures for anxiety and pain in our study
251 State-Trait Anxiety Inventory STAI The State-Trait Anxiety Inventory STAI consists of two different parts termed STAI-Trait Anxiety Inventory STAI-TA and STAI-State Anxiety Inventory STAI-SA This test requires patients to complete a 40-item 20 items measuring state anxiety and 20 items measuring trait anxiety Spielberger et al1970 adding each one of the items of each subscale The score can range between 0 and 60 representing the highest and lowest levels of anxiety respectively In our study STAI-TA test results were evaluated preoperatively The STAI-SA was performed during the waiting room Orthopaedic unit 30 minutes before surgery and postoperative period in Post anaesthesia care unit PACU recovery period 30 minutes after surgery There are no cut points but direct scores are transformed into centiles based on sex and age
252 Vale Numerical Scale VNS Pain intensity is frequently measured for visual analogue scale VAS or numerical ranting scale NRS We used the NRS pain was assessed on a 10-point pain intensity numerical rating scale where 0no pain and 10worst possible pain Lee et al2015 The researcher gave oral instruction of Please said the point at the number to show how much pain do you have right now The pain was measured in preoperative intraoperative and postoperative phase
253 Hemodynamic constants To measure HR and BP the researchers placed the sensor on the radial area of the patients forearm for 15 minutes Monitoring of the electrocardiogram ECG and capillary oxygen saturation SatO2 was continuous The participants were asked not to move around to ensure the quality of the readings In our study HR BP and SatO2 was measured by a Datex Ohmeda TYPE D-LCC1503
26 Data collection process This research was approved by the Ethical Committee for Clinical Research approved code PR21816
The researchers SR MR checked the operating schedule and met potential participants in the room of orthopaedic unit where we take the signed consent and we gave them the STAI questionnaire
When the participants reached preoperative area the researchers looked the group that belonged to each participant according to randomization list and they were monitored hemodynamic constants HR BP SatO2 the headphones were placed with or without music and the dose of sedation or physiological serum placebo was administrated according to the study group to which they belonged The dose of sedation or serum was repeated every 45 minutes until surgery was finished All the data STAI preoperative and postoperative VNS preoperative and postoperative hemodynamic constants every 15 minutes dose anaesthetics and analgesics sociodemographic variables were registered in a graph created by researchers
The data collection in each phase preoperative intraoperative and postoperative was carried out by nurses who did not belong to the research team who were educated before starting the study so that there were no biases in the collection
27 Statistical analysis Categorical variables were described by means of the number of cases the percentage with respect to the total by category and the number of available data Continuous variables were described by means of the number of cases the mean and the standard deviation or the median and the inter-quartile range IQR Continuous variables were compared using Students t-test or Mann-Whitney U-test as appropriate Fishers exact test or Pearsons χ2 test were applied to assess the relationship between categorical variables In order to evaluate the main objective a covariance analysis was performed to evaluate the role of the intervention in the change in the value of the final pain compared to initial pain The effects of each intervention were compared by pairs with the adjustment for multiple comparisons of Tukey The rest of the study variables STAI questionnaire and hemodynamic constants BP HR SatO2 were analysed similarly Models were replicated adjusted by age and gender Analyses were performed with R software 340 The statistical significance was set at a probability level 005
28 Ethical considerations The participants who met the inclusion criteria were informed by the researchers and they were also given an informative document of the study The participants who wanted to participate in the study signed an informed consent
41 Limitations When we performed the post-STAI test in the Post Anesthesia Care Unit PACU some patients could not read the questionnaire because they did not have the glasses so the nurse had to ask the questions In future studies a better research design or a more suitable testing location can provide a better understanding on this subject Additional research could examine the effectiveness of listening to preferred music the use of music as an alternative to another type of sedative drug such as propofol for other surgical patients as well as their satisfaction
Conflict of interest and Funding None Acknowledgements The authors thanks all professionals who have collaborated in the study surgery nurses nursing traumatology department and nursing supervision
Thanks especially Dr Xavier Pelfort and Dr Joan Miquel for assistance with study design statistical analysis manuscript review and anaesthetist Dr Josep Mª Bausili for assistance with anaesthesia standardization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None