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IRCT20200818048448N2 IRCT 2022-06-08 Tabriz University of Medical Sciences Comparison of the effect of two upper limb physical restraint type on the clinical outcomes of children under mechanical ventilation 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 2022-06-15 anticipated 48 Complete https://irct.ir/trial/60021 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, 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 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. N/A agitation sedation level. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Study protocol Informed consent form When: The access time will start 6 months after the results are published. To whom: The data will only be available to researchers working at academic institutions. Conditions: Researchers working in academic institutions are allowed to request documentation. Where to obtain: Refer to the person responsible for the general response of the trial. How to obtain: 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. Comments:
public Mahni Rahkar Farshi
Faculty of Nursing and Midwifery, South Shariati Ave, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 rahkarfarshim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mahni Rahkar Farshi
Faculty of Nursing and Midwifery, South Shariati Ave. Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 rahkarfarshim@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 1 year 5 years Both 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 Other Other 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. 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. 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. 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. 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. 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. 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. Tabriz University of Medical Sciences Approved 2022-01-12 Ethics committee of Tabriz University of Medical Sciences Faculty of Nursing and Midwifery, South Shariati Ave. Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)