Protocol summary

Study aim
1- Comparison of pain intensity changes in the four groups before and after the intervention 2- Comparison of heart rate changes in the four groups before and after the intervention
Design
The sample size will be 64 children. By random sampling, 16 children will be placed in each of the four groups, each with 8 girls and 8 boys, randomly divided into four groups: 1. Deep breathing with deep feet. 2. Deep breathing. 3. Depth of foot. 4) Control will be, the sample size will be 16 in each group.In each of the 4 groups, the pain intensity and physiological indices will be measured 3 minutes before and 3 minutes after placement.
Settings and conduct
6-12 years old children referred to the Emergency Hospital of Imam Hossein Harris Hospital, who are diagnosed with a doctor, need to have an intravenous line for them, were randomly divided into four groups: 1. Deep breathing with deep feet. 2. Deep breathing. 3. Death. The gig 4) control. In each of the 4 groups, pain intensity and physiological indices will be measured 3 minutes before and 3 minutes after sedation. In groups 1, 2 and 3, one minute before the venipuncture, Deviation of thought will be done. In groups 1, 2 and 3, one minute before placement, a deviation of thought will be made, which in group 1, will be performed by a deep tail with a nose and at the top of the gingival. In group 2, a deep tail with a nose and exhale will be in the mouth. In group 3, only the ridge will die, and in groups 1 and 3, after the spin in the gig and in group 2, after exhalation, the numbers will be counted up to 10 spins or 10 respiration. The tracking will be done before the end of counting the numbers. In the control group, there will be no intervention, the data will be analyzed after the collection using SPSS22 software
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. The age of the child is 12-6 years old. 2. Be able to count numbers from 1 to 10. 3. The child is alert that there is a possibility of question and answer. 4. Children and parents are willing to cooperate. Exit criteria: 1. Having any life-threatening illness 2. Use of pain relief 3. Catheter insertion more than once into the skin 4. Use of sedative drugs and anticonvulsants
Intervention groups
1) Deep breathing with a finned foot. 2) Deep breathing. 3) Footsteps. 4) control,
Main outcome variables
Changes in pain intensity; changes in heart rate; changes in SPO2

General information

Reason for update
Acronym
-
IRCT registration information
IRCT registration number: IRCT20130617013691N9
Registration date: 2018-01-11, 1396/10/21
Registration timing: retrospective

Last update: 2018-01-11, 1396/10/21
Update count: 0
Registration date
2018-01-11, 1396/10/21
Registrant information
Name
Mohammad Arshadi Bostanabad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
arshadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of medical sciences research
Expected recruitment start date
2016-05-06, 1395/02/17
Expected recruitment end date
2017-06-07, 1396/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of deep breathing, feet off the gig and combining them on intensity of venipuncture pain and Heart Rate and Pulse Oximetry in school age children-A randomized clinical trial
Public title
The effects of deep breathing, feet off gig and combining them on intensity of venipuncture pain and physiological parameters in school age children-A randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The child is 12-6 years of age. The cadence is to count the numbers from 1 to 10. A child is aware that there is a possibility of questions and answers. Children and parents tend to cooperate.
Exclusion criteria:
Having any life-threatening illness Use Housing to relieve pain Catheter more than once into the skin Taking sedative medications and anticonvulsants
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: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling will be available, so that by using a randomized table, children will be randomly assigned to one of four groups. Assignment Sequences are determined using a computer random number table (www.Random.com), and in order to hide the allocation, the opaque packets are numbered sequentially.
Blinding (investigator's opinion)
Not blinded
Blinding description
No blinding
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
South Sharyati Ave
City
Tabriz
Province
East Azarbaijan
Postal code
-
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.TBZMED.REC.1396.171

Health conditions studied

1

Description of health condition studied
Pain intensity
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
The intensity of the pain
Timepoint
3 minutes before and 3 minutes after Iv line
Method of measurement
OUCHER pain tools

Secondary outcomes

1

Description
physiological parameters
Timepoint
3 minutes before and 3 minutes after the Iv line
Method of measurement
Pulsoxymetry devices

Intervention groups

1

Description
Intervention group:In the combined group (deep breathing and hypnosis), the pain intensity and physiological indices are measured 3 minutes before the insertion and recorded in the questionnaire. One minute before the trampling, it is done by a deep tail with a nose and will die in the exhalation of the gingival, and after the death of the gig, the numbers will count up to 10 spins and 10 breaths. After 3 minutes, pain intensity and physiological indices are measured and recorded in the questionnaire. The tracking will be done before the end of counting the numbers
Category
Prevention

2

Description
Intervention group: In the deep breathing group, the pain intensity and physiological indices were measured 3 minutes before the insertion and recorded in the questionnaire. One minute before the pregnancy, a deep tail with a nose is done and the mouth is exhausted, and after each breath, the numbers will count up to 10 breaths. After 3 minutes, pain intensity and physiological indices are measured and recorded in the questionnaire. The tracking will be done before the end of counting the numbers.
Category
Prevention

3

Description
Intervention group: In the gig group, the pain intensity and physiological indices were measured 3 minutes before the insertion and recorded in the questionnaire. A minute before the tuneup, the gig will die, and after the death of the gig, numbers will count up to 10 rotations. After 3 minutes, pain intensity and physiological indices are measured and recorded in the questionnaire. The tracking will be done before the end of counting the numbers.
Category
Prevention

4

Description
Control group: Control group: The pain intensity and physiological indices were measured 3 minutes before the insertion and recorded in the questionnaire. The insertion is done and the measurement of pain intensity and physiological parameters is recorded 3 minutes after the insertion and recorded in the questionnaire.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hosein Hospital
Full name of responsible person
Horiyeh Abdolalizadeh
Street address
Emam Hosein Hospital
City
Heris
Province
East Azarbaijan
Postal code
-
Phone
+98 41 4343 3614
Fax
+98 41 4343 3614
Email
hoabdolalizadeh@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Email
mrashidi@gmail.com
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
Horiyeh Abdolalizadeh
Position
Expert Nursing
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5391835196
Phone
+98 935 759 1402
Fax
+98 41 4343 3512
Email
hoabdolalizadeh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Arshadi Bostanabad
Position
PHD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
South Sharyati Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
3519653918
Phone
+98 41 3479 6770
Fax
+98 41 3479 6770
Email
arshadi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Horiyeh Abdolalizadeh
Position
Nursing Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Pediatrics
Street address
South Sharyati Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5391835196
Phone
+98 41 3479 6770
Fax
+98 41 4343 3512
Email
hoabdolalizadeh@gmail.com
Web page address

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
Individual characteristics of the samples (age, sex, grade of birth, degree of education, parents' education and literacy, place of residence, hospitalization history, number of family members, location of the venue, frequency and economic status), and the form of registration of pain after ineligible Identifying people to be shared.
When the data will become available and for how long
Start the access period, 6 months after printing the results
To whom data/document is available
Data will be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
Use of the data provided for performing statistical analyzes is permitted
From where data/document is obtainable
Contact us at hoabdolalizadeh@gmail.com to receive the data.
What processes are involved for a request to access data/document
After receiving the email from the email address listed, the data will be sent after 24 hours.
Comments
I have no other explanation.
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