The effect of guided imagery on anxiety of children candidate for tonsillectomy
Design
Randomized controlled clinical trial, without placebo. Random number table will be used for randomization.
Settings and conduct
This study will be performed in Amir-Kabir Hospital in Arak on children who are candidates for tonsillectomy. Participants are randomly divided into intervention and control groups. Allocation concealment was not performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 7 to 12 years; lack of previous experience of surgery; no psychological disorders; no hearing disorders; reading and writing skill of mothers.
Exclusion criteria: reluctance of parents and children to participate in the study
Intervention groups
Intervention group: samples of the intervention group listen to an audio file using handsfree for 15 minutes, one hour before surgery. The contents of the audio file contain appropriate and pleasant topics that are combined with soothing music for the child to visualize in his/her mind.
Control group: The control group did not receive any intervention during this time.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211008052701N1
Registration date:2021-11-07, 1400/08/16
Registration timing:prospective
Last update:2021-11-07, 1400/08/16
Update count:0
Registration date
2021-11-07, 1400/08/16
Registrant information
Name
Mahdieh Ajerloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3445 9312
Email address
mmahdieaajerloo1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
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 effect of guided imagery on anxiety of children candidate for tonsillectomy
Public title
The effect of guided imagery on anxiety of children candidate for tonsil surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 7 to 12 years
Lack of previous experience of surgery
No psychological disorders
No hearing disorders
Reading and writing skill of mothers
Exclusion criteria:
Reluctance of parents and children to participate in the study
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
7001
Randomization (investigator's opinion)
Randomized
Randomization description
The samples individually divided into intervention and control groups using simple random allocation method and a random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176593
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.ARAKMU.REC.1400.056
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
Anxiety score in facial anxiety assessment tool
Timepoint
Before and immediately after the intervention
Method of measurement
Facial anxiety assessment tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Samples of the intervention group listen to an audio file using handsfree for 15 minutes one hour before surgery. The contents of the audio file contain appropriate and pleasant topics that are combined with soothing music for the child to visualize in his mind.
Category
Prevention
2
Description
Control group: The control group did not receive any intervention during this time.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Kabir Hospital
Full name of responsible person
Ehsan Rahimi
Street address
Parastar Sq., Rah-Ahan Sq., Shahid Shiroodi St.
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3313 0040
Email
info@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahdieh Ajerloo
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3816991561
Phone
+98 86 3445 9312
Email
mmahdieaajerloo1994@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sharareh Khosravi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3505
Email
research@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahdieh Ajerloo
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3445 9312
Email
mmahdieaajerloo1994@gmail.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
It is provided unrecognizably at the request of individuals.
When the data will become available and for how long
The access period will start after the results are printed.
To whom data/document is available
Researchers at other Universities are allowed access.
Under which criteria data/document could be used
Documentation is provided in order to know how the work is done and to critique it.
From where data/document is obtainable
Sharareh Khosravi
Email: khosravi@arakmu.ac.ir
What processes are involved for a request to access data/document
After stating the purpose of accessing the information, the requested items will be sent via email.