Effect of Music in Intraoperative Period

Not Applicable

Completed

• Conditions: Postoperative Pain; Vital Signs; Perioperative Care; Total Knee Arthroplasty; Music Therapy; Anxiety; Spinal Anesthesia
• Interventions: Other: non-sedated group; Other: music therapy; Other: sedated group

• Registration Number: NCT04485650
• Lead Sponsor: Abant Izzet Baysal University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-24
• Primary Completion: 2017-03-15
• Study Completion: 2017-05-30
• Study First Submitted: 2020-04-24
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Distribution 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	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	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
anxiety assessment 8 hours after surgery	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	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	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	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)
Distribution 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	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	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	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)

Trial Locations

Locations (1)

Faculty of health sciences; 🇹🇷 Bolu, Turkey