The effects of using sound frequencies on analgesia level and hemodynamic disorders during intubation and extubation in patients under general anesthesia
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This update is being made to clarify and complete the registered information regarding the conduct of the study and to improve the consistency of the trial record with the study protocol and the actual procedures used during the study. These updates do not change the overall nature of the intervention or the main objectives of the study.
This update is being made to clarify and complete the registered information regarding the conduct of the study and to improve the consistency of the trial record with the study protocol and the actual procedures used during the study. These updates do not change the overall nature of the intervention or the main objectives of the study.
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این به‌روزرسانی با هدف شفاف‌سازی و تکمیل اطلاعات ثبت‌شده در خصوص نحوه اجرای مطالعه و افزایش تطابق رکورد کارآزمایی با پروتکل مطالعه و روش اجرای واقعی آن انجام شده است.. این به‌روزرسانی با هدف افزایش شفافیت، قابلیت بازتولید و تطابق اطلاعات ثبت‌شده با مطالعه انجام شده است و ماهیت کلی مداخله و اهداف اصلی مطالعه را تغییر نمی‌دهد.
این به‌روزرسانی با هدف شفاف‌سازی و تکمیل اطلاعات ثبت‌شده در خصوص نحوه اجرای مطالعه و افزایش تطابق رکورد کارآزمایی با پروتکل مطالعه و روش اجرای واقعی آن انجام شده است.. این به‌روزرسانی با هدف افزایش شفافیت، قابلیت بازتولید و تطابق اطلاعات ثبت‌شده با مطالعه انجام شده است و ماهیت کلی مداخله و اهداف اصلی مطالعه را تغییر نمی‌دهد.
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.
In Control Group 1, headphones were placed over the patient’s ears; however, the headphones had no audio function and contained openings over the ear area, allowing patients to hear environmental sounds naturally. In Control Group 2, intact but inactive headphones were placed over the patient’s ears, preventing the patients from hearing environmental sounds. In the intervention groups, intact headphones were used to deliver auditory stimulation at the specified frequencies. Because the headphones were visually identical and patients were unaware of their group allocation and the frequency of the auditory stimulation, patients were blinded to both group assignment and intervention frequency. An investigator involved in the project was responsible for administering anesthesia and managing the patients throughout the anesthetic period and was blinded to group allocation and stimulation frequency. Auditory stimulation was delivered through the headphones, with the stimulation frequency configured via the headphones’ Bluetooth connection. Another researcher responsible for recording the study variables was unaware of the patients’ group allocation and the frequency of auditory stimulation received and was blinded to both. Statistical analyses were performed after completion of data collection.
In control groupControl Group 1;, headphones arewere placed onover the patient's ear. Butpatient’s ears; however, the headphones havehad no audio function, and contained openings over the patient is ableear area, allowing patients to hear the surroundingenvironmental sounds naturally through the holes made on the ear part of the headphones. In control groupControl Group 2; healthy, intact but inactive headphones but without sound function arewere placed onover the patient's ear so that he cannot hearpatient’s ears, preventing the surroundingpatients from hearing environmental sounds. In the intervention groups; healthy, intact headphones with a specific frequency arewere used. Due to deliver auditory stimulation at the appearancespecified frequencies. Because the headphones were visually identical and patients were unaware of identical interventionstheir group allocation and the patient's lackfrequency of information about the grouping and type ofauditory stimulation intervention frequency, the patients were blinded to the intervention. Anesthesiaboth group assignment and administration of patients during anesthesia is done byintervention frequency. An investigator involved in the project colleaguewas responsible for administering anesthesia and managing the patients throughout the anesthetic period and was blinded to group allocation and stimulation frequency. AudioAuditory stimulation was delivered through the headphones, with the stimulation frequency was applied throughconfigured via the headphones and audio frequency settings were done through’ Bluetooth headphonesconnection. The other colleague who registersAnother researcher responsible for recording the study variables does not knowwas unaware of the way of groupingpatients’ group allocation and the typefrequency of frequencyauditory stimulation received by the patientsand was blinded to both. Statistical analyses were performed after completion of data collection.
در گروه کنترل 1؛ هدفون بر روی گوش بیمار قرار داده می شود. ولی هدفون فاقد عملکرد می باشد و همچنین از طریق سوراخ های که بر روی قسمت روی گوش هدفون انجام شده است بیمار قادر به شنیدن صداهای محیطی بصورت طبیعی است. در گروه کنترل 2؛ هدفون سالم ولی فاقد عملکرد صوتی بر روی گوش بیمار قرار داده می شود بطوری که قادر به شنیدن صداهای محیطی نباشد. در گروه های مداخله؛ هدفون سالم با فرکانس مشخص استفاده می شود. با توجه به مداخلات ظاهری یکسان و عدم اطلاع بیمار از گروه بندی و نوع فرکانس مداخله تحریکی بیماران نسبت به مداخله کور بودند. انجام بیهوشی و اداره بیماران در طول بیهوشی توسط همکار پروژه انجام می شود. اعمال فرکانس صوتی از طریق هدفون و تنظیمات فرکانس صوتی از طریق بلوتوث هدفون انجام می شد. همکار دیگر ثبت کننده متغییر ها از نحوه گروه بندی و نوع فرکانس دریافتی بیماران اطلاعی ندارد.
در گروه کنترل 1، هدفون روی گوش بیمار قرار داده می‌شد، اما هدفون فاقد عملکرد صوتی بود و به‌دلیل وجود سوراخ‌هایی در قسمت روی گوش هدفون، بیمار قادر بود صداهای محیطی را به‌طور طبیعی بشنود. در گروه کنترل 2، هدفون سالم اما فاقد عملکرد صوتی روی گوش بیمار قرار داده می‌شد، به‌گونه‌ای که بیمار قادر به شنیدن صداهای محیطی نبود. در گروه‌های مداخله، از هدفون سالم برای ارائه تحریک صوتی با فرکانس مشخص استفاده می‌شد. با توجه به ظاهر مشابه هدفون‌ها و عدم اطلاع بیماران از تخصیص گروهی و نوع فرکانس تحریک، بیماران نسبت به گروه و نوع مداخله کور بودند. انجام بیهوشی و اداره بیماران در طول دوره بیهوشی توسط همکار پروژه انجام می‌شد و متخصص بیهوشی نسبت به تخصیص گروهی و نوع فرکانس تحریک کور بود. اعمال تحریک صوتی از طریق هدفون و تنظیم فرکانس صوتی از طریق اتصال بلوتوث هدفون انجام می‌شد. پژوهشگر دیگری که مسئول ثبت متغیرهای مطالعه بود، از تخصیص گروهی و نوع فرکانس صوتی دریافتی بیماران اطلاعی نداشت و نسبت به این موارد کور بود. داده‌ها پس از تکمیل جمع‌آوری داده‌ها مورد تحلیل آماری قرار گرفتند.
در گروه کنترل 1؛، هدفون بر روی گوش بیمار قرار داده می شود. ولیشد، اما هدفون فاقد عملکرد می باشدصوتی بود و همچنین از طریقبهدلیل وجود سوراخ های که بر رویهایی در قسمت روی گوش هدفون انجام شده است، بیمار قادر بود صداهای محیطی را به‌طور طبیعی بشنود. در گروه کنترل 2، هدفون سالم اما فاقد عملکرد صوتی روی گوش بیمار قرار داده می‌شد، به‌گونه‌ای که بیمار قادر به شنیدن صداهای محیطی بصورت طبیعی استنبود. در گروه کنترل 2؛های مداخله، از هدفون سالم ولی فاقد عملکردبرای ارائه تحریک صوتی بر روی گوش بیمار قرار داده می شود بطوری که قادر به شنیدن صداهای محیطی نباشد. در گروه های مداخله؛ هدفون سالم با فرکانس مشخص استفاده می شودشد. با توجه به مداخلات ظاهری یکسانظاهر مشابه هدفون‌ها و عدم اطلاع بیماربیماران از گروه بندیتخصیص گروهی و نوع فرکانس مداخله تحریکیتحریک، بیماران نسبت به گروه و نوع مداخله کور بودند. انجام بیهوشی و اداره بیماران در طول دوره بیهوشی توسط همکار پروژه انجام می شودشد و متخصص بیهوشی نسبت به تخصیص گروهی و نوع فرکانس تحریک کور بود. اعمال فرکانستحریک صوتی از طریق هدفون و تنظیماتتنظیم فرکانس صوتی از طریق اتصال بلوتوث هدفون انجام می‌شد. همکار دیگرپژوهشگر دیگری که مسئول ثبت کننده متغییر هامتغیرهای مطالعه بود، از نحوه گروه بندیتخصیص گروهی و نوع فرکانس صوتی دریافتی بیماران اطلاعی نداردنداشت و نسبت به این موارد کور بود. داده‌ها پس از تکمیل جمع‌آوری داده‌ها مورد تحلیل آماری قرار گرفتند.
Primary outcomes
#1
Heart rate is measured before, immediately and also in 1, 3 and 5 minutes after intubation and extubation.
It is measured immediately and at 1, 2, 3, 4, and 5 minutes after intubation and extubation.
Heart rateIt is measured before, immediately and also inat 1, 2, 3, 4, and 5 minutes after intubation and extubation.
ضربان قلب قبل، بلافاصله و همچنین در دقایق 1، 3 و 5 بعد از لوله گذاری و خارج کردن لوله اندازه گیری می شود.
بلافاصله و همچنین در دقایق 1، 2، 3، 4 و 5 بعد از لوله گذاری و خارج کردن لوله اندازه گیری می شود.
ضربان قلب قبل، بلافاصله و همچنین در دقایق 1، 2، 3، 4 و 5 بعد از لوله گذاری و خارج کردن لوله اندازه گیری می شود.
#2
Systolic and diastolic blood pressure
mean arterial pressure
Systolic and diastolic bloodmean arterial pressure
فشار خون سیستولیک و دیاستولیک
فشار خون میانگین
فشار خون سیستولیک و دیاستولیکمیانگین
Systolic and diastolic Blood pressure is measured before, immediately and also in 1, 3 and 5 minutes after intubation and extubation.
It is measured immediately and at 1, 2, 3, 4, and 5 minutes after intubation and extubation.
Systolic and diastolic Blood pressureIt is measured before, immediately and also inat 1, 2, 3, 4, and 5 minutes after intubation and extubation.
فشار خون سیستولیک و دیاستولیک قبل، بلافاصله و همچنین در دقایق 1، 3 و 5 بعد از لوله گذاری و خارج کردن لوله اندازه گیری می شود.
بلافاصله و همچنین در دقایق 1، 2، 3، 4 و 5 بعد از لوله گذاری و خارج کردن لوله اندازه گیری می شود.
فشار خون سیستولیک و دیاستولیک قبل، بلافاصله و همچنین در دقایق 1، 2، 3، 4 و 5 بعد از لوله گذاری و خارج کردن لوله اندازه گیری می شود.
Systolic and diastolic blood pressure
using a monitor connected to the patient.
Systolic and diastolic blood pressureusing a monitor connected to the patient.
#3
Before leaving the recovery department
Before discharge from the recovery unit and at 1, 3, and 6 hours after surgery.
Before leavingdischarge from the recovery departmentunit and at 1, 3, and 6 hours after surgery.
قبل از خروج از بخش ریکاوری
قبل از خروج از بخش ریکاوری و در ساعات 1، 3و 6 بعد از جراحی
قبل از خروج از بخش ریکاوری و در ساعات 1، 3و 6 بعد از جراحی
#4
Using patient-connected monitoring
using a monitor connected to the patient
Usingusing a monitor connected to the patient-connected monitoring
#5
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Bispectral Index value during general anesthesia
Bispectral Index value during general anesthesia
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مقدار شاخص دوطیفی در طی بیهوشی عمومی
مقدار شاخص دوطیفی در طی بیهوشی عمومی
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Before induction of general anesthesia, after induction of general anesthesia, and at 15, 30, 45, and 60 minutes, as well as after extubation.
Before induction of general anesthesia, after induction of general anesthesia, and at 15, 30, 45, and 60 minutes, as well as after extubation.
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قبل از القای بیهوشی عمومی، پس از القای بیهوشی عمومی، و در دقایق ۱۵، ۳۰، ۴۵، ۶۰ و بعد از اکستوباسیون
قبل از القای بیهوشی عمومی، پس از القای بیهوشی عمومی، و در دقایق ۱۵، ۳۰، ۴۵، ۶۰ و بعد از اکستوباسیون
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Continuous monitoring using a bispectral index monitor with a disposable forehead sensor
Continuous monitoring using a bispectral index monitor with a disposable forehead sensor
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پایش مداوم با استفاده از دستگاه اندازه‌گیری شاخص دوطیفی و حسگر یک‌بارمصرف پیشانی
پایش مداوم با استفاده از دستگاه اندازه‌گیری شاخص دوطیفی و حسگر یک‌بارمصرف پیشانی
Intervention groups
#1
Control group: patients do not receive any stimulation intervention.
Control 1 group: perforated wireless headphones are placed over both ears, and patients do not receive any auditory stimulus or stimulation intervention. The perforated headphones allow ambient sounds to remain audible.
Control 1 group: perforated wireless headphones are placed over both ears, and patients do not receive any auditory stimulus or stimulation intervention. The perforated headphones allow ambient sounds to remain audible.
گروه کنترل: بیماران هیچ گونه مداخله تحریکی دریافت نمی کنند.
گروه کنترل1: گروه کنترل: هدفون بی‌سیم سوراخ‌دار روی هر دو گوش قرار داده می‌شود و بیماران هیچ‌گونه محرک یا مداخله تحریک صوتی دریافت نمی‌کنند. هدفون سوراخ‌دار امکان شنیدن صدای محیط را فراهم می‌کند
گروه کنترل1: گروه کنترل: هدفون بی‌سیم سوراخ‌دار روی هر دو گوش قرار داده می‌شود و بیماران هیچ‌گونه محرک یا مداخله تحریکیتحریک صوتی دریافت نمی‌کنند. هدفون سوراخ‌دار امکان شنیدن صدای محیط را فراهم می‌کند
#2
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.
Control 2 group: passive wireless headphones are placed over both ears to reduce the intensity of ambient sound to less than 5 dB, and patients in this group do not receive any sound stimuli.
Control 2 group: passive wireless headphones are placed on each ear so thatover both ears to reduce the intensity of the ambient sound isto less than 5 dB, and the patients in this group do not receive any sound stimuli.
گروه کنترل: هدفون بی سیم غیرفعال روی هر دوگوش قرار داده می شود تا شدت دریافت صدای محیط به کمتر از 5 دسی بل برسد و بیماران در این گروه هیچ محرک صوتی دریافت نمی کنند.
گروه کنترل 2: هدفون بی‌سیم غیرفعال روی هر دو گوش قرار داده می‌شود تا شدت صدای محیط به کمتر از 5 دسی‌بل برسد و بیماران در این گروه هیچ محرک صوتی دریافت نمی‌کنند.
گروه کنترل 2: هدفون بی‌سیم غیرفعال روی هر دوگوشدو گوش قرار داده می‌شود تا شدت دریافت صدای محیط به کمتر از 5 دسی‌بل برسد و بیماران در این گروه هیچ محرک صوتی دریافت نمی‌کنند.
Protocol summary
Study aim
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
This update is being made to clarify and complete the registered information regarding the conduct of the study and to improve the consistency of the trial record with the study protocol and the actual procedures used during the study. These updates do not change the overall nature of the intervention or the main objectives of the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20240123060780N3
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2026-10-08, 1405/07/16
Update count:1
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
Recruitment complete
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
2
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 were placed over the patient’s ears; however, the headphones had no audio function and contained openings over the ear area, allowing patients to hear environmental sounds naturally. In Control Group 2, intact but inactive headphones were placed over the patient’s ears, preventing the patients from hearing environmental sounds. In the intervention groups, intact headphones were used to deliver auditory stimulation at the specified frequencies. Because the headphones were visually identical and patients were unaware of their group allocation and the frequency of the auditory stimulation, patients were blinded to both group assignment and intervention frequency. An investigator involved in the project was responsible for administering anesthesia and managing the patients throughout the anesthetic period and was blinded to group allocation and stimulation frequency. Auditory stimulation was delivered through the headphones, with the stimulation frequency configured via the headphones’ Bluetooth connection. Another researcher responsible for recording the study variables was unaware of the patients’ group allocation and the frequency of auditory stimulation received and was blinded to both. Statistical analyses were performed after completion of data collection.
Placebo
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
It is measured immediately and at 1, 2, 3, 4, and 5 minutes after intubation and extubation.
Method of measurement
Using monitoring connected to the patient
2
Description
mean arterial pressure
Timepoint
It is measured immediately and at 1, 2, 3, 4, and 5 minutes after intubation and extubation.
Method of measurement
using a monitor connected to the patient.
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 discharge from the recovery unit and at 1, 3, and 6 hours after surgery.
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 a monitor connected to the patient
7
Description
Heart rate
Timepoint
Every 15 minutes during anesthesia and also before leaving the recovery room
Method of measurement
Using patient-connected monitoring
8
Description
Bispectral Index value during general anesthesia
Timepoint
Before induction of general anesthesia, after induction of general anesthesia, and at 15, 30, 45, and 60 minutes, as well as after extubation.
Method of measurement
Continuous monitoring using a bispectral index monitor with a disposable forehead sensor
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 1 group: perforated wireless headphones are placed over both ears, and patients do not receive any auditory stimulus or stimulation intervention. The perforated headphones allow ambient sounds to remain audible.
Category
Placebo
2
Description
Control 2 group: passive wireless headphones are placed over both ears to reduce the intensity of ambient sound to less than 5 dB, and 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.