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IRCT20230722058885N1 IRCT 2023-11-24 Tabriz University of Medical Sciences " Effect of local heat on venipuncture in children"; " effect of massage on venipuncture in children" Comparison of two methods of local heat and massage on outcomes of venipuncture in hospitalized children: A randomized controlled clinical trial 2023-10-22 anticipated 96 Complete https://irct.ir/trial/71692 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be done by the available method and using the Rand List program and random block method of three and six will be assigned to three groups of control, intervention 1 and intervention 2. In order to hide the assignment of children to three groups, opaque and sealed envelopes will be used, in such a way that the type of group is written on a sheet of paper and numbered inside the opaque envelopes. The envelopes will be opened by a person not involved in the study (department secretary) in the order of children's entry into the study, and the relevant group will be determined. Verbal information about the goals and how to conduct the study will be provided by the researcher to the children and their parents, Blinding description: Due to the nature of the conducted interventions, it is not possible to blind the researcher, help of researchers and samples, and blinding will be done only in the data analysis phase of the study (statistical consultant). N/A Comparison of the effect of local heat and massage on pain and duration of venipuncture in hospitalized children. Intervention 1: Intervention group1: The first intervention group: local heat with a heating pad, for 5 minutes, between 38-42 degrees Celsius. Intervention 2: Intervention group2: Skin massage for two minutes. Intervention 3: Control group: Non-interventional venipuncture. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known, there is no more information.
public Samieh Naseri Nahr
No 20, Shaghayegh ave, Ferdous street, El Goli, Tabriz
Tabriz Iran (Islamic Republic of) 5167954416 +98 936 996 0451 samiehnn@gmail.com Tabriz University of Medical Sciences scientific Samieh Naseri Nahr
No 20, Shaghayegh ave, Ferdous street, El Goli, Tabriz
Tabriz Iran (Islamic Republic of) 5167954416 +98 936 996 0451 samiehnn@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Children aged 6 to 12 admitted to one of the internal or surgical departments of the hospital Indication of peripheral vein catheter insertion Having a Difficult Venous Access (DIVA) score ≥4 Not prescribing painkillers or anesthetics 4 hours before inserting the IV catheter Absence of bleeding disorders The ability to communicate verbally 6 years 12 years Both Skin sensitivity or the presence of wounds, eczema and skin rashes in the area The presence of cognitive impairment in the child Child's malaise or non-cooperation XXI Persons encountering health services for examination and investigation(Z00-Z13) Other Other Other Intervention group1: The first intervention group: local heat with a heating pad, for 5 minutes, between 38-42 degrees Celsius. Intervention group2: Skin massage for two minutes Control group: Non-interventional venipuncture Duration of vein cannulation. Timepoint: By placing the cannula in the vein, the time interval from the moment the needle enters the skin until the needle exits and guiding the cannula to the end in the vein. Method of measurement: Using a stopwatch. Pain during intravenous cannulation. Timepoint: Immediately after cannulation of venipuncture. Method of measurement: Visual Analog Scale. Evaluation of visibility and palpability of peripheral veins. Timepoint: Before and after intervention (local heat and massage). Method of measurement: Vein Assessment Scale. Tabriz University of Medical Sciences Approved 2023-10-16 Ethics committee of Tabriz University of Medical sciences No.20,second Shaghayegh ave,Ferdows street,Elgholi,Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)