The effects of using sound frequencies on analgesia level and hemodynamic disorders during intubation and extubation in patients under general anesthesia
Determining the effects of using sound frequencies on the level of analgesia and hemodynamic disorders during intubation and extubation in patients under general anesthesia.
Design
The current study is a randomized double-blind clinical trial in phase 2 with a control group, which is conducted on 175 patients. The randomization of the samples is done using the order of random letters by computer software.
Settings and conduct
The study is conducted on elective candidates for general anesthesia in Imam Reza Hospital, Kermanshah. In the intervention groups, the application of different sound frequencies during the process of general anesthesia is done by headphones. The patients and the researcher who recorded the data do not know about the grouping and the type of intervention.
Participants/Inclusion and exclusion criteria
Patients who are under general anesthesia.
Intervention groups
In control group 1; patients do not receive any sound stimulation.
In control group 2; passive wireless headphones are placed on both ears of the patient so that the ambient sound intensity is less than 5 dB and the patient does not receive any sound stimuli. In the intervention groups: sound stimulation with frequencies of 5, 10, 20, 50 and 100 Hz from the time of entering the operating room until the patient leaves the recovery room through wireless headphones, receives sound stimulation with a sound intensity of 50 dB.
Main outcome variables
Changes in blood pressure; change in heart rate ; pain level; comfort; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240123060780N3
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Rasoul Kavyannejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4618
Email address
r.kavyannejad@kums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of using sound frequencies on analgesia level and hemodynamic disorders during intubation and extubation in patients under general anesthesia
Public title
Effects of sound frequencies on analgesia and hemodynamic changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a history of underlying diseases such as blood pressure, diabetes, heart and lung diseases
Patients with American Society of Anesthesiology (ASA) classification 1 and 2
Airway grade 1
Not receiving premedication the night before and the morning of the operation
having full normal hearing (25 dB hearing threshold)
Having full consciousness
Exclusion criteria:
History of smoking and addiction
Having an ear infection and anatomical abnormalities of the auditory system
Non-cooperation of the patient
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
175
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of samples in this study is done by computer software.Due to the 7 groups, a random order of letters A, B, C, D, E, F, G is made in blocks with a random number of 7 letters. Each letter is a symbol of one of the study groups. Then these obtained blocks are placed in sealed envelopes. Before starting the study, one of the researchers opens one of the envelopes and finally the patient is placed in one of the intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In control group 1; headphones are placed on the patient's ear. But the headphones have no function, and the patient is able to hear the surrounding sounds naturally through the holes made on the ear part of the headphones. In control group 2; healthy headphones but without sound function are placed on the patient's ear so that he cannot hear the surrounding sounds. In intervention groups; healthy headphones with a specific frequency are used. Due to the appearance of identical interventions and the patient's lack of information about the grouping and type of stimulation intervention frequency, the patients were blinded to the intervention. Anesthesia and administration of patients during anesthesia is done by the project colleague. Audio frequency was applied through headphones and audio frequency settings were done through Bluetooth headphones. The other colleague who registers the variables does not know the way of grouping and the type of frequency received by the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-01-30, 1402/11/10
Ethics committee reference number
IR.KUMS.REC.1403.102
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
2
Description of health condition studied
surgical pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Heart rate
Timepoint
Heart rate is measured before, immediately and also in 1, 3 and 5 minutes after intubation and extubation.
Method of measurement
Using monitoring connected to the patient
2
Description
Systolic and diastolic blood pressure
Timepoint
Systolic and diastolic Blood pressure is measured before, immediately and also in 1, 3 and 5 minutes after intubation and extubation.
Method of measurement
Systolic and diastolic blood pressure
3
Description
Anxiety
Timepoint
It is measured before induction of anesthesia.
Method of measurement
The visual analog scale
4
Description
comfort
Timepoint
It is measured before induction of anesthesia.
Method of measurement
The visual analog scale
5
Description
Pain
Timepoint
Before leaving the recovery department
Method of measurement
The visual analog scale
6
Description
Systolic and diastolic blood pressure
Timepoint
Every 15 minutes during anesthesia and also before leaving the recovery room
Method of measurement
Using patient-connected monitoring
7
Description
Heart rate
Timepoint
Every 15 minutes during anesthesia and also before leaving the recovery room
Method of measurement
Using patient-connected monitoring
Secondary outcomes
1
Description
The amount of narcotic drugs used for analgesia (morphin) in the recovery department
Timepoint
It is measured in the recovery section.
Method of measurement
In terms of milligrams of the drug injected by anesthesia personnel
Intervention groups
1
Description
Control group: patients do not receive any stimulation intervention.
Category
Placebo
2
Description
Control group: passive wireless headphones are placed on each ear so that the intensity of the ambient sound is less than 5 dB, and the patients in this group do not receive any sound stimuli.
Category
Placebo
3
Description
Intervention group: patients receive sound stimulation with a frequency of 5 Hz and sound intensity of 50 dB through wireless headphones.
Category
Treatment - Devices
4
Description
Intervention group: patients receive sound stimulation with a frequency of 10 Hz and sound intensity of 50 dB through wireless headphones.
Category
Treatment - Devices
5
Description
Intervention group: patients receive sound stimulation with a frequency of 20 Hz and sound intensity of 50 dB through wireless headphones.
Category
Treatment - Devices
6
Description
Intervention group: patients receive sound stimulation with a frequency of 50 Hz and sound intensity of 50 dB through wireless headphones.
Category
Treatment - Devices
7
Description
Intervention group: patients receive sound stimulation with a frequency of 100 Hz and sound intensity of 50 dB through wireless headphones.