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The effect of three distraction strategies (playroom, watching cartoons and drawing) on the level of pre-surgery anxiety of children and parents

Protocol summary

Study aim
Comparison of the effect of playroom, watching cartoons and drawing on pre-surgery anxiety of 6-12 year old children admitted to Pastor Education Center and the parents of said children in 1402
Design
A controlled, parallel-group, unblinded, non-randomized clinical trial involving 160 patients.
Settings and conduct
At the time of data collection, after self-introduction and explanation about the study, written consent is obtained from eligible samples if desired. Children enter the intervention and control groups based on the days of the week. Saturday and Sunday drawing group, Monday and Tuesday game group and Wednesday and Thursday cartoon watching group. After sampling from the intervention group, sampling is done from the control group. In this intervention, according to the procedure, all children are placed in a room in the operating room with their parents for 15 to 30 minutes before surgery. After examining the anxiety of children and their parents, the intervention group is given the opportunity to play, draw and watch cartoons, but no intervention is done for the control group. About 15 to 30 minutes after entering the waiting room and before anesthesia, the anxiety of children and their parents is checked.
Participants/Inclusion and exclusion criteria
Children 6 to 12 years old ؛ Children who have used oral and intravenous anti-anxiety drugs
Intervention groups
Before surgery, all children spend 15 to 30 minutes with their parents in a room located in the operating room. Facilities for playing games, watching cartoons, and drawing are planned for each of the intervention groups, but there will be no intervention for the control group.
Main outcome variables
By using drawing, playing room and watching cartoons, we try to reduce the amount of stress that children and parents experience before surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231110060009N1
Registration date: 2024-04-30, 1403/02/11
Registration timing: registered_while_recruiting

Last update: 2024-04-30, 1403/02/11
Update count: 0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
zohreh makarem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4421 6602
Email address
z.makarem@mubam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-28, 1402/11/08
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of three distraction strategies (playroom, watching cartoons and drawing) on the level of pre-surgery anxiety of children and parents
Public title
The effect of three distraction strategies (playroom, watching cartoons and drawing) on the level of pre-surgery anxiety of children and parents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children 6 to 12 years old The child's IQ is normal
Exclusion criteria:
The child has used oral and intravenous anti-anxiety drugs
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Bam University of Medical Sciences
Street address
Research and Technology Vice-Chancellor, Bam University of Medical Sciences campus, Khalij fars Blvd
City
Bam
Province
Kerman
Postal code
7661713669
Approval date
2024-01-28, 1402/11/08
Ethics committee reference number
IR.MUBAM.1402.081

Health conditions studied

1

Description of health condition studied
Anxiety level before surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety score based on STAL questionnaire
Timepoint
15-30 minutes before surgery (before intervention) and before induction of anesthesia
Method of measurement
STAL questionnaire

2

Description
The percentage of people whose STAL questionnaire score is above 42
Timepoint
15-30 minutes before surgery (before intervention) and before induction of anesthesia
Method of measurement
STAL questionnaire

Secondary outcomes

1

Description
Child's anxiety score
Timepoint
before the intervention and after the intervention (5 minutes before going to the operating room)
Method of measurement
state-train anxiety inventory 40-question questionnaire

2

Description
Parental anxiety score
Timepoint
before the intervention and after the intervention (5 minutes before going to the operating room)
Method of measurement
state-train anxiety inventory 40-question questionnaire

Intervention groups

1

Description
The first intervention group: For children in the drawing group, an A4 paper with dimensions (0.21 x 0.29 cm) and a pack of 12 colored pencils are provided to the child and he is asked to draw as he wishes. The second intervention group: the play group, the child is placed in the play room with his parents and the child is asked to play with the available toys as he wishes. The third intervention group: cartoon watching group, 5 attractive cartoons containing age-appropriate content related to treatment and coping strategies are provided to the child, and a cartoon is played on the child's laptop as desired.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Pastor Hospital
Full name of responsible person
Hossein Agha Askari
Street address
Kerman, Bam, 5 km of Bam Barwat road
City
BAM
Province
Kerman
Postal code
7661961676
Phone
+98 34 4431 9400
Email
pastor@mubam.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
sajjad khosravi
Street address
Research and Technology Vice-Chancellor, Bam University of Medical Sciences campus, Khalij fars Blvd
City
Bam
Province
Kerman
Postal code
7661713669
Phone
+98 34 4422 0911
Email
research@mubam.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bam 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
Bam University of Medical Sciences
Full name of responsible person
Narjes Elahi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
No. 13, 17 Arg, Arg St
City
BAM
Province
Kerman
Postal code
7661855455
Phone
+98 34 4431 3356
Email
narjesellahi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Zohreh Makarem
Position
Master of science in nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.111 Azadi alley Azadi square
City
Bam
Province
Kerman
Postal code
7661316871
Phone
+98 34 4421 6602
Fax
Email
z.makarem@mubam.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Zohreh Makarem
Position
Master of science in nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.111 Azadi alley Azadi square
City
Bam
Province
Kerman
Postal code
7661316871
Phone
+98 34 4421 6602
Fax
Email
z.makarem@mubam.ac.ir

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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
data can be shared after individuals are de-identified
When the data will become available and for how long
The access period starts 6 months after publication
To whom data/document is available
All researchers working in scientific and academic institutions and people who work in this industry can access the data
Under which criteria data/document could be used
It is not possible to reuse the data with the same statistical test. If there is a need to use the data, the researchers will send their title and purpose via email and after consulting with the authors, the final decision will be made. The data of the article cannot be used directly.
From where data/document is obtainable
To receive information, you can refer to the following emails z.makarem@mubam.ac.ir narjesellahi@gmail.com
What processes are involved for a request to access data/document
After requesting by e-mail and coordinating with the responsible author Mrs. Makarem, the address of the data will be provided to her by e-mail or the library or website.
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