Comparison of the effect of two upper limb physical restraint type on the clinical outcomes of children under mechanical ventilation: A crossover randomized clinical trial study
Determining and comparing the local consequences of restraint and the degree of agitation in children under mechanical ventilation in 2 methods of restraint at assessment times
Design
It is a single-blind crossover trial on 48 patients. Available sampling and use of Rand List software and use of matte envelope
Settings and conduct
The pediatric icu of Tabriz Children's Educational and Medical Center
One-sided blindness of the study due to the age and clinical condition of the participants
Participants/Inclusion and exclusion criteria
Children aged 1 to 5 years; Being hospitalized in the pediatric icu; Being under mechanical ventilation; The Physician order to use physical restraint in the upper limbs; The consent of the child's parents
No entry conditions:
Existence of intra venous line in both upper limbs; Instability of the child's physiological condition before the intervention; Children with hemiplegia, extensive hematoma, history of surgery or trauma, casts or splints in restrained limbs
Intervention groups
For group A, first wrist restraint and then elbow restraint will be used. In group B, first the elbow is restrained and then the wrist is restrained. The duration of all restraints is 2 hours. Due to the routine physical restraint in the ward and to eliminate the effect of restraint, before the intervention, 15 minutes will be considered as a wash out period and the child will be continuously and directly monitored by the researcher. He will not be restrained, and during this time the researcher will prevent it if he observes the child trying to pull the equipment by keeping the limb calm. During the intervention in both groups, a 15-minute cleansing period will be considered to eliminate the restraint effect after each of the restraints.
Main outcome variables
Palm temperature; Number of radial pulses; Edema of the hand; Clinical erythema of the hand; The degree of agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200818048448N2
Registration date:2022-06-08, 1401/03/18
Registration timing:prospective
Last update:2022-06-08, 1401/03/18
Update count:0
Registration date
2022-06-08, 1401/03/18
Registrant information
Name
Mahni Rahkar Farshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
rahkarfarshim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-15, 1401/03/25
Expected recruitment end date
2022-10-17, 1401/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two upper limb physical restraint type on the clinical outcomes of children under mechanical ventilation: A crossover randomized clinical trial study
Public title
Comparison of the effect of two upper limb physical restraint type on the clinical outcomes of children under mechanical ventilation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 1 to 5 years
Being hospitalized in the pediatric intensive care unit
Being under mechanical ventilation
Physician order to use physical restraint in the upper limb
The consent of the child's parents
Exclusion criteria:
Existence of intra venous line in both upper limbs
Instability of the child's physiological condition before the intervention
Children with hemiplegia, extensive hematoma, history of surgery or trauma in the restrained limb
Children with casts or splints in restrained limbs
Age
From 1 year old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible children will be selected by available sampling method and will be randomly divided into two groups A and B by using Rand List software. The random sequence created will be covered using matte envelopes, and the envelopes will be given to the researcher in order of number, and after opening the envelope, the child's group will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in this study are children who, due to age and clinical condition, will not have real knowledge of the type of intervention performed.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, South Shariati Ave. Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5143377505
Approval date
2022-01-12, 1400/10/22
Ethics committee reference number
IR.TBZMED.REC.1400.1039
Health conditions studied
1
Description of health condition studied
agitation sedation level
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
erythema
Timepoint
Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the start of the intervention and measurement after the intervention will be performed immediately after the end of the two hours of the intervention.
Method of measurement
clinician erythema assessment
2
Description
Edema of the hand
Timepoint
Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the start of the intervention and measurement after the intervention will be performed immediately after the end of the two hours of the intervention.
Method of measurement
Figure-of-Eight Method of Measuring Hand
3
Description
Palm temperature
Timepoint
Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the start of the intervention and measurement after the intervention will be performed immediately after the end of the two hours of the intervention.
Method of measurement
Digital thermometer
4
Description
Radial pulse
Timepoint
Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the start of the intervention and measurement after the intervention will be performed immediately after the end of the two hours of the intervention.
Method of measurement
Manually count the number of radial pulses per minute
5
Description
Agitation and sedation
Timepoint
Measurements before the intervention will be reviewed and recorded after the initial cleansing period and before the intervention begins. Measurement during the intervention will be done one hour after the start of the intervention and measurement after the intervention will be performed immediately after the end of the two hours of the intervention.
Method of measurement
Richmond Agitation-Sedation Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For group A, first wrist restraint will be done for two hours and then elbow restraint will be done for two hours. Due to the physical restraint performed routinely and to eliminate the effect of restraint, before the intervention, a period of 15 minutes will be considered as a wash out period and the child will be observed by the executive researcher under continuous and direct observation and without restraint. During this time, the researcher will prevent the child from trying to pull the equipment by keeping the limb calm. To restrain the wrist, medical gauze three to five centimeters wide (depending on the child's body) will be used, inside which a cotton roll will be placed. A roll of gauze and cotton is wrapped around the wrist and a long strip of gauze is tied from one end around the roll and from the other end to the bed in the form of the number eight. To prevent pressure on the limb, a distance of one finger (index finger) will be considered between the gas roll and the skin. To apply elbow restraint, two splints with pads, one below and one on the elbow joint, will be used. Then the upper part of the splints on the arm side and the lower part of the splints on the forearm side will be closed using two separate gas strips. In this way, the gas strip is wrapped around the splints and limbs and will be fastened on the upper splint with a simple knot. To prevent pressure on the limb, a distance of one finger (index finger) will be considered between the gas strip and the skin. The size of the splints used will be chosen based on the child's body so that it covers the upper and lower thirds of the elbow joint.
Category
Other
2
Description
Intervention group: For group B, after a 15-minute wash-out time, first the elbow is restrained for two hours and then the wrist is restrained for two hours. The method of applying wrist and elbow restraint will be the same as the method applied in group A intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mardaniazar Medical Center
Full name of responsible person
Abbasali Dorosti
Street address
Khavaran
City
Tabriz
Province
East Azarbaijan
Postal code
513377505
Phone
+98 41 3336 1018
Email
mardaniazari@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Vice Chancellor for Research and Technology, No. 2 , Central Building, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
0000000000
Phone
+98 41 3334 4280
Email
research-vice@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
Mahni Rahkar Farshi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, South Shariati Ave, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
rahkarfarshim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahni Rahkar Farshi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, South Shariati Ave. Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
rahkarfarshim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahni Rahkar Farshi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, South Shariati Ave. Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
rahkarfarshim@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study protocol
Informed consent form
When the data will become available and for how long
The access time will start 6 months after the results are published.
To whom data/document is available
The data will only be available to researchers working at academic institutions.
Under which criteria data/document could be used
Researchers working in academic institutions are allowed to request documentation.
From where data/document is obtainable
Refer to the person responsible for the general response of the trial.
What processes are involved for a request to access data/document
The request is sent to the person in charge of the trial and with the coordination of the research vice chancellor of the university, documents will be sent.