Determining the effect of bubble-making game therapy on the level of anger and anxiety in hospitalized children with seizures
Design
Clinical trial with intervention and control group, single-blind, randomized, phase 3 on 60 patients. For randomization, odd numbers will correspond to the control group and even numbers will correspond to the intervention group..
Settings and conduct
The intervention was performed in children 8-12 years of age with seizures hospitalized in two hospitals in Karaj. The severity of anger and anxiety in a child with epilepsy was measured by the researcher with the Anger and Anxiety Scale 5 minutes before the start and 5 minutes after the venipuncture and was compared and recorded with the answers to the initial questionnaire.
In the control group, the same measures were performed without a bubble maker
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 8-12 years old. Children with convulsions hospitalized, Parental consent, The second and third day of hospitalization, Children who are not being treated for anxiety or anger.
Exclusion criteria: Child discharge, Child malnutrition, Children with high levels of anxiety and anger
Intervention groups
In the intervention group, the bubble machine was given to the child by the researcher 5 minutes before the insertion of the vein by the nurse and 5 minutes after that, and the insertion of the vein will be done by a nurse, then the intensity of anger and anxiety of the child with epilepsy 5 minutes before the start And 5 minutes after taking the vein, it will be measured by the researcher with the scale of anger and anxiety and will be compared and recorded with the answers of the initial questionnaire. Routine procedures will be performed in the control group.
Main outcome variables
Anger and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210129050175N1
Registration date:2023-10-03, 1402/07/11
Registration timing:retrospective
Last update:2023-10-03, 1402/07/11
Update count:0
Registration date
2023-10-03, 1402/07/11
Registrant information
Name
Leyla Ebrahimpour somarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3456 2980
Email address
ebrahimpour.14736@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-11, 1401/08/20
Expected recruitment end date
2022-12-11, 1401/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bubble therapy on anger and anxiety in Children with seizures hospitalized
Public title
The effect of bubble therapy on anger and anxiety in children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The child is hospitalized on the second and third day.
Children who are not being treated and followed up for anxiety or anger.
Children aged 12-8 years
Children with seizures hospitalized
Parent and child satisfaction based on the presence of the child in the research
Exclusion criteria:
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in this research was done in such a way that the samples were made available in a purposeful way in order to include children in the research and were randomly divided into two control and intervention groups. During vein sampling, the odd numbers related to the control group and the even numbers related to the intervention group were included.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are blinded because similar problems would arise if the patient knew what treatment she was receiving.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Medical Sciences Branch of Tehr
Street address
The corrected address is: "Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Gol Yakh St. corner, Ayane Blvd., Golhak Du Rahi, Amir Pabarja St., Dr. Shariati St., Tehran."
City
Tehran
Province
Tehran
Postal code
3195637839
Approval date
2021-07-13, 1400/04/22
Ethics committee reference number
IR.IAU.TMU.REC.1400.235
Health conditions studied
1
Description of health condition studied
Convulsions
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anger and anxiety
Timepoint
5 minutes before and 5 minutes after venipuncture
Method of measurement
Nelson Anger Scale and Spielberger Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, a "bubble maker" provided by the researcher was used from five minutes before the nurse's vein insertion until five minutes afterward for the hospitalized child with seizures. The child was allowed to play with one hand during the vein insertion.
Category
Treatment - Devices
2
Description
In the control group, a nurse with expertise in venipuncture conducted the procedure in a standard ward without any additional intervention. The child's levels of anger and anxiety were assessed by the researcher using an anger scale, both 5 minutes before and after the venipuncture. The control group's anxiety levels were also measured and recorded.