Evaluating the effectiveness of listening to classical music during general anesthesia compared to white noise in reducing propofol consumption during vitrectomy surgery
Evaluating and comparing the impact of classical music on the consumption of propofol during vitrectomy surgery
Design
A clinical trial with a control group with parallel groups, double-blind, randomized using a random numbers table, in two groups of 25 people.
Settings and conduct
After obtaining consent, the study will involve all adults over the age of 18 who undergo vitrectomy surgery at Imam Hossein hospital in Tehran. A headset is put on the patient after general anesthesia. During the patient's admission into the operating room, an anesthesia technician randomly chooses the patient's group and plays the audio file corresponding to that group for the patient (intervention group, classical music file; control group, white noise file). The anesthesiologist in charge of the patient will record the variables assessed during and after the procedure in the questionnaire. No one will be informed of the patient's group except the first technician until the questionnaire is finished and the patient exits the operating room.
Participants/Inclusion and exclusion criteria
After obtaining informed consent from the patients, all patients over 18 years of age referred to the operating room for vitrectomy surgery will be examined. Patients with hearing impairment, mental health problems, long-term use of sedatives or painkillers, and people with alcohol addiction or other illegal drugs will be excluded from the study.
Intervention groups
Classical music will be used in the intervention group and white noise will be used in the control group (a type of sound that is created by combining sounds with different frequencies and is used as a control group in various music therapy studies).
Main outcome variables
Propofol dosage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120910010800N6
Registration date:2022-10-02, 1401/07/10
Registration timing:prospective
Last update:2022-10-02, 1401/07/10
Update count:0
Registration date
2022-10-02, 1401/07/10
Registrant information
Name
Dariush Abtahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2263 2611
Email address
d.abtahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of listening to classical music during general anesthesia compared to white noise in reducing propofol consumption during vitrectomy surgery
Public title
Effect of music during general anesthesia on propofol consumption during vitrectomy surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists (ASA) Physical Status Classification System I and II
vitrectomy surgery
Age above 18 years
Consent to study
Exclusion criteria:
hearing impairment
mental health problem
prolonged use of sedatives or analgesics
alcoholism or other illicit drug addiction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two intervention and control groups using six blocks of four in permutation blocks, and this process will be continued until all research participants have been enrolled. When the patient enters the operating room, the anesthesia technician performs this task and plays the audio player file that corresponds to the patient's group. Until the patient exits the operating room, the patient group won't be identifiable to anybody else.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before performing anesthesia, an anesthesiologist will select the patient group using colored cards without the knowledge of the anesthesiologist, surgeon, and patient. After the induction of general anesthesia, headphones will be placed on the patient and the same technician will play the appropriate file for the group. The sound played for the patient will be at a level that cannot be heard by others. The headphones remain in place until the end of the surgery, and when the patient wakes up, the sound is stopped and then the headphones are removed. Until the questionnaire information is completed and the patient is removed from the operating room, no one except the technician will be aware of the patient's group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University of Medical Science
Street address
Emam Hossein Hospital, Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.286
Health conditions studied
1
Description of health condition studied
Vitrectomy Surgery
ICD-10 code
Z98.89
ICD-10 code description
Other specified postprocedural states
Primary outcomes
1
Description
Propofol consumption level
Timepoint
End of surgery
Method of measurement
A standard anesthesia sheet is used in the patient file to determine the total amount of propofol used in mg. The patient's propofol consumption at the beginning of anesthesia and then it is recorded in the file as standard and at the end the total amount is added together.
Secondary outcomes
1
Description
Post-operative nausea and vomiting
Timepoint
In recovery room
Method of measurement
Questionnaire
2
Description
Blood pressure
Timepoint
During and after the surgery
Method of measurement
Monitoring device
3
Description
Heart rate
Timepoint
During and after the surgery
Method of measurement
Monitoring device
4
Description
Bispectral index
Timepoint
During surgery
Method of measurement
Bispectral index device
5
Description
Pain
Timepoint
After surgery
Method of measurement
Using visual analog scale
Intervention groups
1
Description
Intervention group: After general anesthesia, a headphone is placed on the patient and the classical music file is played through it. The loudness of the sound is checked in advance using a sound sample for the comfort of the patient and is set below 85 dB (to prevent ear damage) based on the recommendation of the World Health Organization. The headphones remain in place until the end of the surgery. When the patient starts to wake up, the sound is stopped and the headphones are removed.
Category
Treatment - Other
2
Description
Control group: the white noise file is played for the patient. White noise is a type of sound that is created by combining sounds with different frequencies. If you combine all the imaginable sounds that a human can hear, white noise will be created. The adjective white has been chosen to describe this type of sound for the same reason that it is used to describe white light. Various studies use this sound to compare groups under music therapy as a control group.