Investigating the effect of nurse's voice notification on agitation and recovery time after general anesthesia in laparoscopic cholecystectomy surgery in teaching hospitals of Mashhad in 2024
This study aims to determine the effect of nurse's voice notification on agitation and recovery time after general anesthesia in laparoscopic cholecystectomy surgery in educational hospitals of Mashhad.
Design
A randomized controlled clinical trial with a control group will be conducted on 54 patients. Random Allocation software is used for randomization.
Settings and conduct
This study will be a randomized controlled clinical trial research that will be conducted on patients undergoing laparoscopic cholecystectomy surgery in the surgical department of Mashhad teaching hospitals. In the intervention group, after the cholecystectomy surgery, the patients will be informed by the voice of the nurse.
In the control group, they will only hear their names and receive the routine care that is done in the operating room for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Candidate patients for laparoscopic cholecystectomy and need general anesthesia
Body mass index below 35
Completing the written informed consent form to participate in the research
The patient's first surgical experience
Non- inclusion criteria:
Having a history of anesthesia or sedation in the last month
Having a hearing problem or cognitive impairment
Addiction to drugs and psychotropic substances
Having a history of mental illness
Use of neuropsychiatric drugs
Having a history of hearing impairment
The possibility of malignancy
Intervention groups
In the intervention group, after the cholecystectomy surgery, the patients will be informed by the voice of the nurse.
In the control group, they will only hear their names and receive the routine care that is done in the operating room for all patients.
Main outcome variables
Postoperative recovery time, restlessness or agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240529061947N1
Registration date:2024-06-23, 1403/04/03
Registration timing:registered_while_recruiting
Last update:2024-06-23, 1403/04/03
Update count:0
Registration date
2024-06-23, 1403/04/03
Registrant information
Name
effat tanhaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 204 7833
Email address
tanhaies14@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of nurse's voice notification on agitation and recovery time after general anesthesia in laparoscopic cholecystectomy surgery in teaching hospitals of Mashhad in 2024
Public title
The effect of nurse's voice on agitation and recovery time after general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for laparoscopic cholecystectomy and need general anesthesia
Body mass index below 35
Completing the written informed consent form to participate in the research
The patient's first surgical experience
Exclusion criteria:
Having a history of anesthesia or sedation in the last month
Having a hearing problem or cognitive impairment
Addiction to drugs and psychotropic substances
Having a history of mental illness
Use of neuropsychiatric drugs
Having a history of hearing impairment
The possibility of malignancy
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization
For this purpose, 10 blocks of 6 members will be used, this means that all 6 patients will be equally divided into control and intervention groups. (A total of 30 people in the intervention group and 30 people in the control group). Determination of random blocks is done with the help of Random Allocation software. In order to hide the random allocation, we will use opaque sealed envelopes with a random sequence.
In this method, after creating a random sequence with the help of software, based on the sample size of a number of envelopes, each of the created random sequences is recorded on cards and placed inside the envelopes. Then, based on the order of entry of qualified participants into the study, one of the envelopes will be opened and the group assigned to the patient will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Asadabadi St
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617213112
Approval date
2024-05-28, 1403/03/08
Ethics committee reference number
IR.MEDSAB.REC.1403.023
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis
Primary outcomes
1
Description
Recovery time after surgery
Timepoint
It is calculated after the completion of the patient's recovery.
Method of measurement
Recovery time checklist
2
Description
Agitation score
Timepoint
Before auditory stimulation, during extubation, 5 minutes later, when entering recovery and every 10 minutes to the first 30 minutes during recovery.
Method of measurement
Richmond restlessness tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After cholecystectomy surgery, patients will be informed by the nurse's voice. The voice of one of the nurses of the ward who is responsible for the patient's care and performed all the pre-operative care of the patient will be played in all the people of the intervention group.In all the people of the intervention group, the voice of one of the nurses of the ward, who is responsible for the patient's care and performed all the pre-operative care of the patient, will be broadcast. "You are waking up from anesthesia. Your surgery has been successfully completed. You are fine. Don't worry. This is the operating room of the hospital.. Mashhad. Please open your eyes." The patient has breathing capacity and necessary cooperation, can be extubated and opens his eyes. The sound is played through headphones with a sound intensity in the normal hearing range of 50 to 60 decibels.
Category
Treatment - Other
2
Description
Control group: Samples will only hear their names and receive the routine care that is done in the operating room for all patients.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Mashhad Hospital
Full name of responsible person
Seyed Majid Hosseini
Street address
Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3180 2723
Email
imam.reza.hos@gmail.com
2
Recruitment center
Name of recruitment center
Ghaem Mashhad Hospital
Full name of responsible person
Gholam Ali Mamouri
Street address
Ahmadabad St
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3801 2465
Email
MaamouriGh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Kazem Hassanpour
Street address
Nuclear martyrs Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4401 8101
Email
vc.Research@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Asadabadi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4401 8310
Email
ghasemimr901@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Asadabadi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4401 8310
Email
ghasemimr901@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Effat Tanhaie
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khayam blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 937 204 7833
Fax
Email
tanhaies14@medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD