Protocol summary
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Study aim
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Determination and comparison of the effect of painting therapy and Midazolam on the level of anxiety in children undergoing tonsillectomy
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Design
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Clinical trial on 90 children with control group, non blinded; randomized based on random numbers table.
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Settings and conduct
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the anxiety level of children undergoing tonsillectomy aged 5 to 12 years in the operating room of Imam Khomeini Hospital in Kermanshah during the years of 97-98 will be measured .Children will be divided into three groups of painting,drug and control group.Then the anxiety level will be measured for each group at the entrance to the waiting room. After intervention ,in the operating room on the bed and before anesthesia, their anxiety level will be measured again using the VAS-A, STAIC, and mYPAS anxiety scales.
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Participants/Inclusion and exclusion criteria
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Participants are children who undergo tonsillectomy surgery. Inclusion criteria are:
Admission of patient at the night before surgery
Children between 5 and 12 years
Informed consent of parents
Exclusion criteria:
Physiological and psychological diseases
Previous surgery history
Previous anesthesia history
Consumption of special drugs
Dissatisfaction of parents
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Intervention groups
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The samples consist of three groups of painting therapy, drug therapy and control.
The control group will include children who have not taken an intervention and they will recieve routin cares.
The painting group is placed under the intervention of a painting with markers and color pencil before surgery, and they will color caricature images of the operating room.
The drug group will receive 0.020 mg / kg IV midazolam before surgery.
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Main outcome variables
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Anxiety
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181117041683N1
Registration date:
2019-02-05, 1397/11/16
Registration timing:
prospective
Last update:
2019-10-15, 1398/07/23
Update count:
1
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Registration date
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2019-02-05, 1397/11/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-21, 1397/11/01
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Expected recruitment end date
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2019-09-22, 1398/06/31
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Actual recruitment start date
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2019-03-09, 1397/12/18
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Actual recruitment end date
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2019-07-11, 1398/04/20
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Trial completion date
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2019-07-11, 1398/04/20
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Scientific title
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A comparative Study of the effect of painting therapy and drug therapy on the anxiety of children undergoing tonsillectomy
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Public title
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Effect of painting therapy and midazolam on anxiety
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Admission of patient at the night before surgery
Children between 5 and 12 years
Type of surgery: Tonsillectomy
Consent of parents
Exclusion criteria:
Physiological and psychological disease
Surgery history
Anesthesia history
Consumption of special drugs
Dissatisfaction of parents
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Age
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From 5 years old to 12 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Initial sampling will be available in a non-randomized way.Then, the samples in this study will be assigned by random allocation of patients in the study groups (control, medication intervention and artistic intervention). Samples will be assigned to three groups by random sampling block Permutation. In this way, the study will continue until the number of samples has been completed.
To implement this randomization method, the following will be done:
1. The total sample size and sample size ratio will be specified in the groups.
2. Single digit numbers between 0 and 9 will be selected from random numbers table.
3.For studies with 3 groups, numbers 0-9 will be divided into 3 equal blocks, wich the probability of allocating one to each block will be 0.5. Block 1-3 will be used for the first group and block 4-6 for the second group and block 7-9 for the third group.It will be determined by numbers selected from random numbers table and blocks determination that anyone who has entered the study will be placed in which group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Similar studies have been conducted on several surgeries, but none have studied just one particular surgery. Since the type of surgery affects the amount of anxiety, we have studied only the tonsillectomy surgery, which is the second most commonly used surgical procedure in children.Recent studies have also compared some supportive interventions with midazolam, but none of these studies have compared painting therapy alone with midazolam.
Ethics committees
1
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Ethics committee
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Approval date
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2018-12-05, 1397/09/14
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Ethics committee reference number
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IR.KUMS.REC.1397.684
Health conditions studied
1
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Description of health condition studied
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Anxiety
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Tonsilectomy
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Preoperative anxiety score in anxiety scale
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Timepoint
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1. Before intervention in the waiting room. 2. After intervention and in the operating room at induction of anesthesia
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Method of measurement
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1-State and Trait Anxiety Inventory scale 2-Visual Analoguous Scale 3-modified Yale Preoperative Anxiety Scale
Intervention groups
1
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Description
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Intervention group: Drug therapy - Midazolam hydrochloride - 0/020mg / kg - Single intravenous injection - Pharmaceutical chemistry
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Painting Therapy with Stedler color pencil and marker made in Germany. Asking children to paint about what they imagine about operating room and also providing colorless pictures and caricatures (about operating room and surgical team) to be colored by children.
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Category
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Treatment - Devices
3
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Description
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Control group: Routin care
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available