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The effect of reducing the anxiety of mothers using Atenolol on the anxiety of children undergoing surgery

Protocol summary

Study aim
Determining the effect of reducing maternal anxiety using Atenolol on the level of anxiety of children who are candidates for surgery in hospital
Design
Clinical trial with two groups case and control, 30 children in each group with parallel groups, double-blind, Simple randomization, Demographic profile, Spielberger Anxiety Inventory and the Modified-Yale preoperative anxiety scale questionnaire will be used to collect data.
Settings and conduct
The study would be held in Moradi Hospital in Rafsanjan University of Medical Sciences, Rafsanjan, Iran, Two randomized groups: (intervention Group) The Mothers of children who will be undergoing surgery are going to be given atenolol to reduce their anxiety. (control group) receiving placebo. It is double blind, participants and investigator will not be aware of the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion: Children 10-3 years old Candidate for tonsillectomy, No chronic disease, Having a mother at the time of admission and hospitalization, Not having any previous experience of surgery, No history of central nervous system diseases and mental illnesses. Exclusion: Mother's unwillingness to participate in research contraindication of the use of Atenolol in the mother Refusal to use Atenolol Being non-Iranian
Intervention groups
Treatment group: Mothers of children in the treatment group, will use Atenolol in a single dose, Stat50 mg (orally) the night before surgery. Control group will be taking placebo. Atenolol-like placebo will be used in dark packaged and coded envelopes to blind participants and investigators.
Main outcome variables
Anxiety of children candidates for surgery before induction of anesthesia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190128042525N5
Registration date: 2021-01-27, 1399/11/08
Registration timing: prospective

Last update: 2021-01-27, 1399/11/08
Update count: 0
Registration date
2021-01-27, 1399/11/08
Registrant information
Name
Gholamreza Bazmandegan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0185
Email address
clinical.research@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reducing the anxiety of mothers using Atenolol on the anxiety of children undergoing surgery
Public title
The effect of reducing the anxiety of mothers using Atenolol on the anxiety of children undergoing surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 3-10 years No chronic disease (cancer, liver disease, kidney) Good hearing and ability to speak Having age-appropriate cognitive abilities Having a mother at the time of admission and hospitalization Not having any previous experience of surgery No history of central nervous system diseases and mental illnesses Maternal anxiety
Exclusion criteria:
Mother's unwillingness to participate in research Prohibitions of Atenolol use in the mother Refusal to use Atenolol Being non-Iranian
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups (group one and two) using random numbers' table (simple randomization method).
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, Participants and Investigator will not be aware of the intervention and control groups. In the control group, an atenolol-like placebo (starch tablets) will be used in dark packaged and coded envelopes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Approval date
2020-12-02, 1399/09/12
Ethics committee reference number
IR.RUMS.REC.1399.208

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Effects of reducing maternal anxiety using Atenolol on the level of anxiety in children of surgical candidates
Timepoint
The night before surgery
Method of measurement
1- Demographic profile questionnaire, 2- Children's Anxiety Scale (Modified-Yale Preoperative Anxiety Scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Mothers of children will be given, single dose of ethanolol, Stat 50 mg (orally) the night before surgery
Category
Prevention

2

Description
Control group: an atenolol-like placebo will be used in dark packaged and coded envelopes
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Moradi Hospital
Full name of responsible person
Farshid Farahbakhsh
Street address
Sَhohada Street, Moalem Street
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Web page address
http://www.rums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Farshid Farahbakhsh
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Web page address
http://www.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Farshid Farahbakhsh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research85@gmail.com
Web page address
http://www.rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Farshid Farahbakhsh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Web page address
http://www.rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Farshid Farahbakhsh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ali Ibn Abitaleb Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Web page address
http://www.rums.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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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