Music TherapyNCT04485650
Effect of Music in Intraoperative Period
A study testing music therapy, sedated group and non-sedated group in people with Music Therapy and Perioperative Care, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Background and Aims: Music therapy has a wide range of uses in health care practice. The aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Music Therapy, Perioperative Care, Postoperative Pain
- What is being tested?
- music therapy, sedated group and non-sedated group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2017to 30 May 2017
- 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
- The patients that had an orthopedic operation
- The patients who took spinal anesthesia
- able to understand, read and speak Turkish, so they may complete the informed consent and questionaires
- Aged 18 or older
- Have a Body Mass Index (BMI) <40
- ASA (American Society of Anaesthesiologists) I-II-III statuses.
Who cannot join
- Patients with vision and hearing problems and inability to complete questionnaires,
- The patients not have psychiatric disease history and psychiatric drug use,
- The patients not have diseases that could be evaluated as severe (such as heart, kidney, liver failure)
- The patients not underwent emergency surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial
Background and Aims: Music therapy has a wide range of uses in health care practice. The aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status.
Methods: The study was performed in an operating room with a total of 90 patients, of whom 30 were in the music group, 30 were in the control group and 30 were in the sedated group. The ethics committee's approval, institutional permission, and the study participants' written informed consent were obtained. Data were collected using patient information and intraoperative observation form for vital signs as well as through the Visual Analog Scale and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.
- Conditions
- Music Therapy, Perioperative Care, Postoperative Pain, Anxiety, Total Knee Arthroplasty, Vital Signs
- Being tested
- music therapy, sedated group, non-sedated group
- Keywords
- music therapy, perioperative care, postoperative pain, anxiety, total knee arthroplasty, vital signs, spinal aesthesia
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyOther
The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group.
sedated groupOther
Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30
non-sedated groupOther
The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. The number of participants:30 Receives: Other: music therapy |
| Sedated group | Active comparator | Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30 Receives: Other: sedated group |
| Non-sedated group | Other | The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30 Receives: Other: non-sedated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Measurement of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Measured: Change from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Distribution of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Measurement of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Measured: Change from Baselinebdiastolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Measurement of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Measured: Change from Baseline pulse rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Distribution of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Measurement of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Measured: Change from Baseline of patients respiratory rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
anxiety assessment 30 minutes before surgery
State- Trait Anxiety Scale was applied to all three groups in preoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)
Measured: State- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgery
anxiety assessment 8 hours after surgery
State- Trait Anxiety Scale was applied to all three groups in postoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)
Measured: State- Trait Anxiety Scale was applied to all three groups in 8 hours after surgery
pain assessment in the operating room
The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain
Measured: The pain was assessed at the end of the operation in 10 minutes with numerical pain scale
Postoperative pain at 1 hours
The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain.
Measured: The pain was assessed followed at 1 hours postoperative period with numerical pain scale
Postoperative pain at 8 hours
The pain was assessed with numerical pain. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0)
Measured: The pain was assessed followed at 8 hours postoperative period with numerical pain scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start24 Feb 2017
- Primary completion15 Mar 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- In the study, 30 patients were assigned to the music group, 30 patients were assigned to the group that received sedation and 30 patients were assigned to a group that was not sedated, all occurred in a randomized controlled way. The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. Sedation (Dormicum) was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The patients in the non-sedated group were followed without any procedure (sedation and music).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ümmühan yiğit, msc, Principal investigator, research assistantarzu ilçe, proffesor, Principal investigator, faculty of health science of deanibrahim karagöz, phd, Principal investigator, anesthesiology and reanimation doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485650
- Sponsor's protocol ID
- AIBU-AML-UY-01
- Status last verified
- Jul 2020
- First submitted
- 24 Apr 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: when the planned number of participants was reached, the data were coded in a statistical program and shared with other researchers
Publications
Koc H, Erk G, Apaydin Y, Horasanli E, Yigitbasi B, Dikmen B. The Effects of Classical Turkish Music on Patients Undergoing Inguinal Hernia Repair under Epidural Anesthesia. Turk Anaesth Int Care. 2009;37:366-373.
Sener EB, Koylu N, Ustun FE, Kocamanoglu S, Ozkan F. The effects of music, white noise and operating room noise on perioperative anxiety in patients under spinal anesthesia. European Journal Of Anaesthesiology (EJA). 2010;24:133
Uyar M, Akin Korhan E. [The effect of music therapy on pain and anxiety in intensive care patients]. Agri. 2011 Oct;23(4):139-46. doi: 10.5505/agri.2011.94695. Turkish.
PubMed 22290677Bansal P, Kharrod U, Sanwatsarkar S, Patel H, Kamat H. The Effect Of Music Therapy On Sedative Requirements And Haemodynamic Parameters In Patients Under Spinal Anaesthesia; A Prospective Study. Journal Of Clinical And Diagnostic Research. 2010;4:2782-2789.
Liu Y, Petrini MA. Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. Complement Ther Med. 2015 Oct;23(5):714-8. doi: 10.1016/j.ctim.2015.08.002. Epub 2015 Aug 4.
PubMed 26365452Allen K, Golden LH, Izzo JL Jr, Ching MI, Forrest A, Niles CR, Niswander PR, Barlow JC. Normalization of hypertensive responses during ambulatory surgical stress by perioperative music. Psychosom Med. 2001 May-Jun;63(3):487-92. doi: 10.1097/00006842-200105000-00019.
PubMed 11382277Bae I, Lim HM, Hur MH, Lee M. Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complement Ther Med. 2014 Apr;22(2):251-7. doi: 10.1016/j.ctim.2014.02.002. Epub 2014 Feb 23.
PubMed 24731896Komurcu E, Kiraz HA, Kaymaz B, Golge UH, Nusran G, Goksel F, Sahin H, Omur D, Hanci V. The effect of intraoperative sounds of saw and hammer on psychological condition in patients with total knee arthroplasty: prospective randomized study. ScientificWorldJournal. 2015;2015:690569. doi: 10.1155/2015/690569. Epub 2015 Feb 22.
PubMed 25793222Sarkar D, Chakraborty K, Bhadra B, Ghorai TK, Singh R, Mandal U. Effects of music on patients undergoing orthopaedic surgery under spinal anaesthesia. IOSR Journal of Dental and Medical Sciences. 2015;14:2279-2861.
Chou MH, Lin MF. Exploring the listening experiences during guided imagery and music therapy of outpatients with depression. J Nurs Res. 2006 Jun;14(2):93-102. doi: 10.1097/01.jnr.0000387567.41941.14.
PubMed 16741859Bailey L. Strategies for decreasing patient anxiety in the perioperative setting. AORN J. 2010 Oct;92(4):445-57; quiz 458-60. doi: 10.1016/j.aorn.2010.04.017.
PubMed 20888947Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth. 2002 Oct;49(8):792-8. doi: 10.1007/BF03017410.
PubMed 12374706Carr E, Brockbank K, Allen S, Strike P. Patterns and frequency of anxiety in women undergoing gynaecological surgery. J Clin Nurs. 2006 Mar;15(3):341-52. doi: 10.1111/j.1365-2702.2006.01285.x.
PubMed 16466484Gursoy A A. Anxiety Levels of Preoperative Patients and Determining the Factors That May Cause Anxiety. Journal of Nursing Research. 2001;1:23-29.
Turhan Y, Avci R, Ozcengiz D. The Relationship Between Preoperative And Postoperative Anxiety, And Patient Satisfaction In Preparation For Elective Surgery. Journal of Anesthesia. 2012;20:27-33
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04485650
- Acronym / sponsor ID
- AIBU-AML-UY-01
- Conditions
- Music Therapy, Perioperative Care, Postoperative Pain, Anxiety, Total Knee Arthroplasty, Vital Signs
- Keywords
- music therapy, perioperative care, postoperative pain, anxiety, total knee arthroplasty, vital signs, spinal aesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 24 Jul 2020 (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 and Aims: Music therapy has a wide range of uses in health care practice. The aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status.
Methods: The study was performed in an operating room with a total of 90 patients, of whom 30 were in the music group, 30 were in the control group and 30 were in the sedated group. The ethics committee's approval, institutional permission, and the study participants' written informed consent were obtained. Data were collected using patient information and intraoperative observation form for vital signs as well as through the Visual Analog Scale and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- In the study, 30 patients were assigned to the music group, 30 patients were assigned to the group that received sedation and 30 patients were assigned to a group that was not sedated, all occurred in a randomized controlled way. The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. Sedation (Dormicum) was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The patients in the non-sedated group were followed without any procedure (sedation and music).
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: music therapyThe music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. The number of participants:30 |
| Sedated group | Active comparator | Other: sedated groupSedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30 |
| Non-sedated group | Other | Other: non-sedated groupThe patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patients that had an orthopedic operation
- The patients who took spinal anesthesia
- able to understand, read and speak Turkish, so they may complete the informed consent and questionaires
- Aged 18 or older
- Have a Body Mass Index (BMI) <40
Key exclusion criteria (4 listed)
- Patients with vision and hearing problems and inability to complete questionnaires,
- The patients not have psychiatric disease history and psychiatric drug use,
- The patients not have diseases that could be evaluated as severe (such as heart, kidney, liver failure)
- The patients not underwent emergency surgeries
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 therapyThe music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. | Other | Music group |
| sedated groupSedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30 | Other | Sedated group |
| non-sedated groupThe patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30 | Other | Non-sedated group |
Primary outcome
Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Time frame: Change from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Measurement of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Distribution of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Time frame: Change from Baselinebdiastolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Measurement of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Time frame: Change from Baseline pulse rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Measurement of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Distribution of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Time frame: Change from Baseline of patients respiratory rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
Measurement of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
anxiety assessment 30 minutes before surgery
Time frame: State- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgery
State- Trait Anxiety Scale was applied to all three groups in preoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)
anxiety assessment 8 hours after surgery
Time frame: State- Trait Anxiety Scale was applied to all three groups in 8 hours after surgery
State- Trait Anxiety Scale was applied to all three groups in postoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)
pain assessment in the operating room
Time frame: The pain was assessed at the end of the operation in 10 minutes with numerical pain scale
The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain
Postoperative pain at 1 hours
Time frame: The pain was assessed followed at 1 hours postoperative period with numerical pain scale
The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain.
Postoperative pain at 8 hours
Time frame: The pain was assessed followed at 8 hours postoperative period with numerical pain scale
The pain was assessed with numerical pain. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0)
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 24 Jul 2020.
- BackgroundKoc H, Erk G, Apaydin Y, Horasanli E, Yigitbasi B, Dikmen B. The Effects of Classical Turkish Music on Patients Undergoing Inguinal Hernia Repair under Epidural Anesthesia. Turk Anaesth Int Care. 2009;37:366-373.
- BackgroundSener EB, Koylu N, Ustun FE, Kocamanoglu S, Ozkan F. The effects of music, white noise and operating room noise on perioperative anxiety in patients under spinal anesthesia. European Journal Of Anaesthesiology (EJA). 2010;24:133
- Background: PubMed 22290677Uyar M, Akin Korhan E. [The effect of music therapy on pain and anxiety in intensive care patients]. Agri. 2011 Oct;23(4):139-46. doi: 10.5505/agri.2011.94695. Turkish.
- BackgroundBansal P, Kharrod U, Sanwatsarkar S, Patel H, Kamat H. The Effect Of Music Therapy On Sedative Requirements And Haemodynamic Parameters In Patients Under Spinal Anaesthesia; A Prospective Study. Journal Of Clinical And Diagnostic Research. 2010;4:2782-2789.
- Background: PubMed 26365452Liu Y, Petrini MA. Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. Complement Ther Med. 2015 Oct;23(5):714-8. doi: 10.1016/j.ctim.2015.08.002. Epub 2015 Aug 4.
- Background: PubMed 11382277Allen K, Golden LH, Izzo JL Jr, Ching MI, Forrest A, Niles CR, Niswander PR, Barlow JC. Normalization of hypertensive responses during ambulatory surgical stress by perioperative music. Psychosom Med. 2001 May-Jun;63(3):487-92. doi: 10.1097/00006842-200105000-00019.
- Background: PubMed 24731896Bae I, Lim HM, Hur MH, Lee M. Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complement Ther Med. 2014 Apr;22(2):251-7. doi: 10.1016/j.ctim.2014.02.002. Epub 2014 Feb 23.
- Background: PubMed 25793222Komurcu E, Kiraz HA, Kaymaz B, Golge UH, Nusran G, Goksel F, Sahin H, Omur D, Hanci V. The effect of intraoperative sounds of saw and hammer on psychological condition in patients with total knee arthroplasty: prospective randomized study. ScientificWorldJournal. 2015;2015:690569. doi: 10.1155/2015/690569. Epub 2015 Feb 22.
- BackgroundSarkar D, Chakraborty K, Bhadra B, Ghorai TK, Singh R, Mandal U. Effects of music on patients undergoing orthopaedic surgery under spinal anaesthesia. IOSR Journal of Dental and Medical Sciences. 2015;14:2279-2861.
- Background: PubMed 16741859Chou MH, Lin MF. Exploring the listening experiences during guided imagery and music therapy of outpatients with depression. J Nurs Res. 2006 Jun;14(2):93-102. doi: 10.1097/01.jnr.0000387567.41941.14.
- Background: PubMed 20888947Bailey L. Strategies for decreasing patient anxiety in the perioperative setting. AORN J. 2010 Oct;92(4):445-57; quiz 458-60. doi: 10.1016/j.aorn.2010.04.017.
- Background: PubMed 12374706Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth. 2002 Oct;49(8):792-8. doi: 10.1007/BF03017410.
- Individual participant dataSharing planned: No. when the planned number of participants was reached, the data were coded in a statistical program and shared with other researchers
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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.
ümmühan yiğit, msc principal investigator
research assistant
arzu ilçe, proffesor principal investigator
faculty of health science of dean
ibrahim karagöz, phd principal investigator
anesthesiology and reanimation doctor
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 therapy, sedated group and non-sedated group in people with Music Therapy and Perioperative Care, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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 24 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 Turkey (Türkiye). 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?
Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups (time frame: Change from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative). The study lists 9 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 NCT04485650, which also lists 26 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 24 Jul 2020.