Effect of Music in Intraoperative Period

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial

Conditions
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Music Therapy, Perioperative Care, Postoperative Pain, Anxiety, Total Knee Arthroplasty, Vital Signs, Spinal Anesthesia

Intervention / Treatment
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* Other: music therapy
* Other: sedated group
* Other: non-sedated group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music group<br>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 | Other: music therapy<br>* 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.<br>|
| Active Comparator: Sedated group<br>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 | Other: sedated group<br>* 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<br>|
| Other: Non-sedated group<br>The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30 | Other: non-sedated group<br>* The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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. | 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) | The pain was assessed followed at 8 hours postoperative period with numerical pain scale | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, total knee arthroplasty, music therapy, perioperative care, postoperative pain, vital signs, spinal aesthesia