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Effect of Music in Intraoperative Period

Primary Purpose

Music Therapy, Perioperative Care, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music therapy
sedated group
non-sedated group
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Music Therapy focused on measuring music therapy, perioperative care, postoperative pain, anxiety, total knee arthroplasty, vital signs, spinal aesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of health sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Music group

Sedated group

Non-sedated group

Arm 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

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

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

Outcomes

Primary Outcome Measures

Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
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
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
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
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 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 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 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 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 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)

Secondary Outcome Measures

Full Information

First Posted
April 24, 2020
Last Updated
July 21, 2020
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04485650
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
March 15, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music group
Arm Type
Experimental
Arm 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
Arm Title
Sedated group
Arm Type
Active Comparator
Arm 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
Arm Title
Non-sedated group
Arm Type
Other
Arm Description
The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30
Intervention Type
Other
Intervention Name(s)
music therapy
Intervention 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.
Intervention Type
Other
Intervention Name(s)
sedated group
Intervention 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
Intervention Type
Other
Intervention Name(s)
non-sedated group
Intervention Description
The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30
Primary Outcome Measure Information:
Title
Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Description
Measurement 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
Title
Distribution of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Description
Measurement 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
Title
Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Description
Measurement 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
Title
Distribution of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
Description
Measurement 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
Title
anxiety assessment 30 minutes before surgery
Description
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)
Time Frame
State- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgery
Title
anxiety assessment 8 hours after surgery
Description
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)
Time Frame
State- Trait Anxiety Scale was applied to all three groups in 8 hours after surgery
Title
pain assessment in the operating room
Description
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
Time Frame
The pain was assessed at the end of the operation in 10 minutes with numerical pain scale
Title
Postoperative pain at 1 hours
Description
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.
Time Frame
The pain was assessed followed at 1 hours postoperative period with numerical pain scale
Title
Postoperative pain at 8 hours
Description
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)
Time Frame
The pain was assessed followed at 8 hours postoperative period with numerical pain scale

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ümmühan yiğit, msc
Organizational Affiliation
research assistant
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
arzu ilçe, proffesor
Organizational Affiliation
faculty of health science of dean
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ibrahim karagöz, phd
Organizational Affiliation
anesthesiology and reanimation doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of health sciences
City
Bolu
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
when the planned number of participants was reached, the data were coded in a statistical program and shared with other researchers
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Effect of Music in Intraoperative Period

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