Effect of Music in Intraoperative Period

Abant Izzet Baysal University

Status: Completed

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

Treatments: Other: non-sedated group; Other: music therapy; Other: sedated group

Study type: Interventional

Funder types: Other

Identifiers

NCT04485650

AIBU-AML-UY-01

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Music group

Experimental group

Description:

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

Treatment:

Other: music therapy

Sedated group

Active Comparator group

Description:

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

Treatment:

Other: sedated group

Non-sedated group

Other group

Description:

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

Treatment:

Other: non-sedated group