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IRCT20171015036790N2 IRCT 2019-01-29 Islamic Azad University Effect of deep breathing and computer games on pain caused by intravenous injection in children with leukemia Comparison of two methods of deep breathing and computer games on pain caused by intravenous injections in school age children with leukemia 2017-11-22 anticipated 90 Complete https://irct.ir/trial/27411 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Patients are divided into one of the deep breathing intervention groups (A), computer-controlled intervention (B) and control (C) by lottery, Blinding description: The study is double blind , so that the participants, principal researcher, clinical care giver and data analyzer are not aware of the allocation of the patients. N/A Acute lymphoblastic leukaemia. Intervention 1: First intervention group: 30 children are randomly allocated to this group. Then Hey_Hu technique is taught to the patients before injection.In this method,at first the child takes a deep breath ,exhales while exhales whispering hey. Then he/she inhales deeply again and exhales whispering hu. This is practiced by the child in the order to implement it accurately and is performed 1 minute before till 1 minute after the procedure. The pain of children will be assessed by wong_Baker Pain Measurement Scale every 30 seconds by the researcher. Intervention 2: Second intervention group: In this group, 30 children are randomly allocated. The children in the hand _held computer group play Angry Birds game. Then children start to play the game 3 minutes before the injection till 3 minutes after the procedure. The pain of children will be assessed by Wong_Baker pain Measurement Scale every 30 second by the researcher. Intervention 3: Control group: In this group ,30 children are randomly allocated. Then the nurse does the injection through routine procedure. The pain of children will be assessed 3 minutes before the injection till 3 minutes after the injection by Wong_Baker Pain Measurement Scale every 30 second by the researcher. 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 Due to not being completed
public Mersa sadat Miri Jagharq
No 130, Behvarz 4, Janbazan Blvd
Neyshabour Iran (Islamic Republic of) 9193863397 +98 51 4261 6072 marsamiri@iautmu.ac.ir Islamic Azad University scientific Fatemeh Alaei Karahroodi
Tehran Medical Branch, Islamic Azad University, Khaghani St , Shariati St
Tehran Iran (Islamic Republic of) 1916893813 +98 21 2200 6660 falaeekarahroudy@yahoo.com Tehran Medical Branch, Islamic Azad University Iran (Islamic Republic of) Diagnosis of leukemia by oncologist at least 6 months ago Children aged 6-12 years old Not having acute pain during the vessel puncturing Being alert to time, place and person Need to have an intravenous line Do not use pain medications from 24 hours before the vessel is inserted At least one parent should be with child There is no problem for handheld computer games Lack of mental retardation 6 years 12 years Both Children in whom first attempt has been failed by the nurse Cardiovascular and respiratory disorders not cooperating child Mentally retarded child Possible child death C91.0 Acute lymphoblastic leukaemia [ALL] Prevention Prevention Prevention First intervention group: 30 children are randomly allocated to this group. Then Hey_Hu technique is taught to the patients before injection.In this method,at first the child takes a deep breath ,exhales while exhales whispering hey. Then he/she inhales deeply again and exhales whispering hu. This is practiced by the child in the order to implement it accurately and is performed 1 minute before till 1 minute after the procedure. The pain of children will be assessed by wong_Baker Pain Measurement Scale every 30 seconds by the researcher. Second intervention group: In this group, 30 children are randomly allocated. The children in the hand _held computer group play Angry Birds game. Then children start to play the game 3 minutes before the injection till 3 minutes after the procedure. The pain of children will be assessed by Wong_Baker pain Measurement Scale every 30 second by the researcher. Control group: In this group ,30 children are randomly allocated. Then the nurse does the injection through routine procedure. The pain of children will be assessed 3 minutes before the injection till 3 minutes after the injection by Wong_Baker Pain Measurement Scale every 30 second by the researcher. Pain. Timepoint: In the intervention group with deep breathing, the child's pain will be measured from 1 minute before the incision until 1 minute after the incision every 30 seconds. In the intervention group with computer games, the child's pain will be measured from 3 minutes before the incision until 3 minutes after the incision every 30 seconds. In the control group, the child's pain will be measured from 3 minutes before the incision until 3 minutes after the incision every 30 seconds. Method of measurement: Vang-Baker pain measurement scale. Islamic Azad University Approved 2017-11-07 Ethics Committee of Islamic Azad University of Medical Sciences of Tehran Islamic Azad University Medical Sciences of TehranĜŒ Khaghani Avenue, Shariati St. Tehran Tehran Iran (Islamic Republic of)