Back to resultsThe Effect of Music on Postoperative Anxiety
Primary Purpose
Anxiety Postoperative
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Patient preferential music
Classical music
No music
Sponsored by
About this trial
This is an interventional other trial for Anxiety Postoperative focused on measuring Patient preferential music, Postoperative anxiety, Classical music
Eligibility Criteria
Inclusion Criteria:
- Undergo inguinal hernia surgery under general anesthesia,
- Being the ability to speak, read and write the Turkish language
Exclusion Criteria:
- Poor vision
- Significant hearing loss
- Dementia
- Active opioid use
- Regular use of anxiolytics or discontinuation of them on the day of surgery
- Unwillingness to participate in the study
- Unwillingness to listening to music
Sites / Locations
- Dışkapı Yıldırım Beyazıt Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Patient preferential music
Classical music
No music
Arm Description
The preference of the patients will be listened to preoperatively through the headphones.
Classical music (Four Seasons from Vivaldi) will be listened to preoperatively through the headphones.
the patients will not listen.
Outcomes
Primary Outcome Measures
Spielberg State-Trait Anxiety Inventory (STAI) score
The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.
Secondary Outcome Measures
Numerical Rating Scale (NRS)
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
The quality of postoperative functional recovery (QoR-40) score
The quality of postoperative functional recovery will assess using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score ranges from 40 (poorest quality of recovery) to 200 (the best quality of recovery). The QoR-40 will administer one day before surgery in outpatient clinics of anesthesiology, and before discharge from hospital on the first postoperative day.
Patient satisfaction score
Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 7) verbally administered questionnaire
Full Information
NCT ID
NCT04277559
First Posted
February 18, 2020
Last Updated
May 18, 2023
Sponsor
Ankara Diskapi Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04277559
Brief Title
The Effect of Music on Postoperative Anxiety
Official Title
Comparison of the Effect of Patient Preferred Music on Postoperative Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Diskapi Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this study, it is planned to compare the effect of listening to the music preferred by the patient and classical music on postoperative anxiety.
Detailed Description
Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 225 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into three groups as preoperative patient preferential music, classical music and not played. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones. The STAI will be repeated at postoperative, the Numeric Rating Scale (NRS) and patient satisfaction will be measured at postoperative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Postoperative
Keywords
Patient preferential music, Postoperative anxiety, Classical music
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient preferential music
Arm Type
Active Comparator
Arm Description
The preference of the patients will be listened to preoperatively through the headphones.
Arm Title
Classical music
Arm Type
Active Comparator
Arm Description
Classical music (Four Seasons from Vivaldi) will be listened to preoperatively through the headphones.
Arm Title
No music
Arm Type
Placebo Comparator
Arm Description
the patients will not listen.
Intervention Type
Other
Intervention Name(s)
Patient preferential music
Intervention Description
Patients will listen to their preferred music through the headphones before surgery.
Intervention Type
Other
Intervention Name(s)
Classical music
Intervention Description
Patients will listen to classical music through headphones before surgery.
Intervention Type
Other
Intervention Name(s)
No music
Intervention Description
Patients will not listen to music.
Primary Outcome Measure Information:
Title
Spielberg State-Trait Anxiety Inventory (STAI) score
Description
The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
Time Frame
24 hours
Title
The quality of postoperative functional recovery (QoR-40) score
Description
The quality of postoperative functional recovery will assess using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score ranges from 40 (poorest quality of recovery) to 200 (the best quality of recovery). The QoR-40 will administer one day before surgery in outpatient clinics of anesthesiology, and before discharge from hospital on the first postoperative day.
Time Frame
24 hours
Title
Patient satisfaction score
Description
Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 7) verbally administered questionnaire
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Undergo inguinal hernia surgery under general anesthesia,
Being the ability to speak, read and write the Turkish language
Exclusion Criteria:
Poor vision
Significant hearing loss
Dementia
Active opioid use
Regular use of anxiolytics or discontinuation of them on the day of surgery
Unwillingness to participate in the study
Unwillingness to listening to music
Facility Information:
Facility Name
Dışkapı Yıldırım Beyazıt Training and Research Hospital
City
Ankara
State/Province
Gölbaşı
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Music on Postoperative Anxiety
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