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The impact of listening to the Quran during general anesthesia on recovery outcomes following vitrectomy surgery.

Protocol summary

Study aim
Determining and comparing the effect of Quran recitation during general anesthesia on the patient's condition in recovery after vitrectomy.
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
This study will be performed on ASA I, II patients who will undergo vitrectomy. After obtaining consent, all Muslim patients over the age of 18 who will refer to the ophthalmology operating room of Imam Hossein Health Center in Tehran for a vitrectomy in the second 5 months of 1400 AH will be included in the study. After general anesthesia, headphones will be placed for all patients. An anesthesia technician will randomly select one of the group files for the patient with the help of a coin toss.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent, Muslim patients, older than 18 years, ASA I, II. Exclusion criteria: Patients with hearing impairment; Mental problems; Continued use of sedatives or analgesics; People addicted to alcohol or illicit drugs.
Intervention groups
Intervention group: using the recitation of the Holy Quran using Surah Al-Hamad and Surah Al-Ma'ida. Control group: using white sound (a type of sound that is created by combining sounds with different frequencies. In different studies, this sound is used to match groups under music therapy as a control group).
Main outcome variables
Blood pressure, heart rate, bispectral index (BIS) of the patient during surgery, the amount of propofol taken at the end of surgery, pain, nausea, vomiting.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120910010800N2
Registration date: 2021-10-01, 1400/07/09
Registration timing: registered_while_recruiting

Last update: 2021-10-01, 1400/07/09
Update count: 0
Registration date
2021-10-01, 1400/07/09
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
2021-09-23, 1400/07/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of listening to the Quran during general anesthesia on recovery outcomes following vitrectomy surgery.
Public title
The impact of listening to the Quran during general anesthesia on recovery outcomes following vitrectomy surgery.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Muslim over than 18 years old Consent to the study
Exclusion criteria:
Impaired hearing Drug abuse Sedative drug use Mental disorder
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected among individuals referring to the operating room of Imam Hossein (AS) hospital for vitrectomy surgery by simple randomization method using a coin toss. In such a way that the selection of the case is done in the case of heads and the selection of control is done in the case of tales.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before performing anesthesia, the anesthesia technician will select one of the audio files of the Quran (group Q) or white sound (group W) for the patient without the anesthesiologist's and the patient's awareness. After general anesthesia, headphones will be placed for all patients. The sound will be played for patients to such an extent that it will not be audible to others in the environment. The headphones will remain in place until the end of the surgery, and when the patient will wake up, the sound stops, and the headphones will be removed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
Emam Hossein Hospital, Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2021-06-28, 1400/04/07
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.207

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
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

Intervention groups

1

Description
Case group: After general anesthesia, headphones will be placed for all patients and the anesthesiologist will select the audio files of the Quran ("Surah Ma'idah" and "Surah Hamad") through headphones for the patient. The volume will be pre-checked using an audio sample for patient comfort and in any case will be set below 85 decibels (to prevent ear damage) according to the WHO recommendation. The headphones will remain in place until the end of surgery, and when the patient will begin to wake up, the sound will be stopped playing and the headphones removed.
Category
Treatment - Other

2

Description
Control group: The anesthesiologist will select the white sound (group W) for the patient. White sound is a type of sound that is produced by combining sounds with different frequencies. If you combine all the imaginable sounds that a human being can hear, a white sound will be created. The adjective white has been chosen to describe this type of sound because it has been used to describe white light. Various studies have used this sound to identify groups under music therapy as a control group.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Emam Hossein
Full name of responsible person
Dariush Abtahi
Street address
Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drdariushabtahi@yahoo.com
Web page address
https://www.ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshhin Zarghi
Street address
Tehran Province, Tehran, Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Web page address
https://en.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital. Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
009821277567840
Email
drdariushabtahi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital. Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
009812277567840
Email
drdariushabtahi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dariush Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital. Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Email
drdariushabtahi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
One year after the publication of the article.
To whom data/document is available
All jobs
Under which criteria data/document could be used
All non-personal patient information (anonymously) can be accessed by contacting the responsible author.
From where data/document is obtainable
email to: drdariushabtahi@yahoo.com
What processes are involved for a request to access data/document
Sending email and review by the responsible author.
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