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Clinical Trials/NCT04485650
NCT04485650
Completed
Not Applicable

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

Abant Izzet Baysal University1 site in 1 country90 target enrollmentFebruary 24, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Music Therapy
Sponsor
Abant Izzet Baysal University
Enrollment
90
Locations
1
Primary Endpoint
anxiety assessment 8 hours after surgery
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 24, 2017
End Date
May 30, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

anxiety assessment 8 hours after surgery

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups

Time Frame: 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

Time Frame: 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

Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Study Sites (1)

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