Comparison of the effect of two methods of listening and reading tales on anxiety and sleep onest time in 8-12 year old in hospitalized children with fractures: a randomized controled clinical trial
Determination and comparison of intra-group and inter-group child's anxiety score and heart rate different measuring times.
Determination and comparing the intra-group, inter-group and length of time to fall asleep at different measuring times.
Design
Randomized clinical trial has 3 groups in parallel groups: 1. Intervention group hearing the story; 2. Intervention group hearing the story and reading simultaneously; and 3. the control group
Settings and conduct
The present study is a randomized clinical trial that will be performed on children aged 8 to 12 admitted with fracture of one of the limbs in Tabriz Shohada Hospital in 2018- 2019. In this study, the children were divided into three groups: Listening to the story; read and listen to the story simultaneously; The control group (with out intervention). Interventions are done in the evening and the night of the second day of hospitalization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Parents should satisfy with the child's participation in the study.
Children should have age from 8 to 12 years.
A family member should exist in the patient bed.
a patient who has not sleep disorders and illnesses associated with sleep.
The patient should have a fracture in one of the organs.
The patient should be a student in the second to the sixth grade
The patient should have no hearing or visual impairment.
Exclusion criteria:
a patient who has multiple trauma
a patient who is not fluent in reading and writing.
a patient who has anxiety disorders.
Intervention groups
In this study, the children were divided into three groups. 1)The groups who listen to the story and 2) the groups who listen and read the story simultaneously (intervention groups)
3)control group( no intervention). The intervention is done in the evening and the night of the second day of hospitalization.
Main outcome variables
Anxiety- Sleep Onest Time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180622040189N1
Registration date:2018-12-15, 1397/09/24
Registration timing:registered_while_recruiting
Last update:2018-12-15, 1397/09/24
Update count:0
Registration date
2018-12-15, 1397/09/24
Registrant information
Name
Azam Romouzi Kouche Bagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3386 1272
Email address
azambagh111@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-05, 1397/08/14
Expected recruitment end date
2019-05-03, 1398/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of listening and reading tales on anxiety and sleep onest time in 8-12 year old in hospitalized children with fractures: a randomized controled clinical trial
Public title
Comparison of the effect of two methods of listening and reading tales on anxiety and sleep onest time
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a history of sleep disorder
Not having anxiety disorder
Exclusion criteria:
Unaccompanied patient
A patient who has multiple trauma
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected using the available method. In the next step, random blocks with 3 sets are assigned to two test groups and one control group. A random sequence is generated using the STATA14 software. Number of blocks 34, size 3.
After blocking, patients (individuals) will assign to study groups by main researcher using generated randomized sequential as they will recruit.like this:
A: First intervention group
B: Second intervention group
C: control group
First person 1 A
2 B
3 C
1 C
2 A
3 B
1 C
2 B
3 A
. .
. .
. .
. .
1 C
2 B
person 102 3 A
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
Regional Ethics College Committee for Biomedical Research, Tabriz University of Medical Sciences
Street address
Golgasht Ave, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2018-07-22, 1397/04/31
Ethics committee reference number
IR.TBZMED.REC.1397.334
Health conditions studied
1
Description of health condition studied
Comparison of the Effect of Two Methods of Listening and Reading Tales on Anxiety and Sleep Onest Time in 8-12 Year Old in Hospitalized Children with Fractures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety Score in Revised Children's Manifest Anxiety Scale
Timepoint
Completion of the anxiety questionnaire on the first day after pulse control and the second day after intervention
Method of measurement
Revised Children's Manifest Anxiety Scale
2
Description
Time to fall asleep children
Timepoint
The first night after 21:30 and the second night after the intervention
Method of measurement
chronometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group heard the story:on the evening of the second day (day of operation), a heart rate measurement was first performed,then the player's headphones are provided to the child and he listens to the researcher's story book stories for 30 minutes.Then the heart rate is recorded and the RCMAS children's apparent anxiety questionnaire (with the exception of polygraph questions) is completed.In the bedtime of the children,the final visit is done,player's headphones available to the child,and child listens to storytelling for 30 minutes in the presence of a researcher, and the time taken from the beginning of the story will be recorded until the child falls asleep.
Category
Other
2
Description
Intervention group: listening and reading the story text simultaneously.The actions performed in this group are like the first group, with the difference that during this intervention, in addition to listening to story, the group also uses the look at story text at the same time.on the evening of the second day (day of operation), a heart rate measurement was first performed,then the story book is available to the child,and for 30 minutes, in the presence of a researcher, while listening to the same story while using the headphone player, the story book is also viewed and followed by the child,then the heart rate is recorded and the RCMAS children's apparent anxiety questionnaire (with the exception of polygraph questions) is completed.In the bedtime of the children,the final visit is done,the story book is available to the child and for 30 minutes in the presence of a researcher while listening to the same tale while using the headphone player the story book is also viewed and followed by the child , and the time taken from the beginning of the story will be recorded until the child falls asleep.
Category
Other
3
Description
Control group: In this group, the researcher visits the department for two consecutive days (including the day of admission and day of operation) and twice a day (evening and night), but there is no intervention. In the evening of the admission day, the researcher's assistance, the number of pulses is determined and recorded by using the pulse oximeter. Then, children listen to story by the player's headphones for 30 minutes. After that, the heart rate is recorded and the questionnaire is completed. On the evening of the second day (day of operation), the heart rate will be measured. The re-connection takes place at 10 o'clock and the length of sleep time will be measured. On the second day (day of operation), the heart rate is recorded twice with a half an hour interval and the time to fall asleep is measured and recorded.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Leyla Valizadeh
Street address
Nursing & Midwifery Faculty, Shariati Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138947978
Phone
+98 41 3479 6770
Email
Valizadehl@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Juiban
Street address
Golgasht Ave, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 5921
Email
info@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Azam Romouzi Kouche Bagh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Faculty, Shariati Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138947978
Phone
+98 41 3479 6770
Fax
Email
azambagh111@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leyla Valizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Faculty, Shariati Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138947978
Phone
+98 41 3479 6770
Email
valizadehl@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
َAzam Romuzi Kouchehbagh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Faculty, Shariati Ave
City
Tehran
Province
East Azarbaijan
Postal code
5138947978
Phone
+98 41 3479 0365
Email
azambagh111@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available