Clinical trial NCT04485650: Effect of Music in Intraoperative Period
Official title: The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Therapy
Perioperative Care
Postoperative Pain
Anxiety
Total Knee Arthroplasty
Vital Signs
Spinal Anesthesia
Keywords: music therapy
perioperative care
postoperative pain
anxiety
total knee arthroplasty
vital signs
spinal aesthesia
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
timeFrame: Change from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
measure: Distribution of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
timeFrame: Change from Baselinebdiastolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
measure: Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
timeFrame: Change from Baseline pulse rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
measure: Distribution of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
timeFrame: Change from Baseline of patients respiratory rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
measure: anxiety assessment 30 minutes before surgery
timeFrame: State- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgery
measure: anxiety assessment 8 hours after surgery
timeFrame: State- Trait Anxiety Scale was applied to all three groups in 8 hours after surgery
measure: pain assessment in the operating room
timeFrame: The pain was assessed at the end of the operation in 10 minutes with numerical pain scale
measure: Postoperative pain at 1 hours
timeFrame: The pain was assessed followed at 1 hours postoperative period with numerical pain scale
measure: Postoperative pain at 8 hours
timeFrame: The pain was assessed followed at 8 hours postoperative period with numerical pain scale
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Faculty of health sciences
Study officials:
affiliation: research assistant
name: ümmühan yiğit, msc
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of health science of dean
name: arzu ilçe, proffesor
role: PRINCIPAL_INVESTIGATOR
affiliation: anesthesiology and reanimation doctor
name: ibrahim karagöz, phd
role: PRINCIPAL_INVESTIGATOR
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