Skip to content

Effect of Music in Intraoperative Period

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04485650
Enrollment
90
Registered
2020-07-24
Start date
2017-02-24
Completion date
2017-05-30
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

music therapy, perioperative care, postoperative pain, anxiety, total knee arthroplasty, vital signs, spinal aesthesia

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.

Interventions

OTHERmusic therapy

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.

OTHERsedated group

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

OTHERnon-sedated group

The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30

Sponsors

Abant Izzet Baysal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-upsChange from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperativeMeasurement 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-upsChange from Baselinebdiastolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperativeMeasurement 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-upsChange from Baseline pulse rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperativeMeasurement 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-upsChange from Baseline of patients respiratory rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperativeMeasurement of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
anxiety assessment 30 minutes before surgeryState- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgeryState- 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 surgeryState- Trait Anxiety Scale was applied to all three groups in 8 hours after surgeryState- 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 roomThe pain was assessed at the end of the operation in 10 minutes with numerical pain scaleThe 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 hoursThe pain was assessed followed at 1 hours postoperative period with numerical pain scaleThe 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 hoursThe pain was assessed followed at 8 hours postoperative period with numerical pain scaleThe 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026