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IRCT20240111060681N1 IRCT 2024-01-22 Research Assistant, Tehran University of Medical Sciences Investigating the effect of the magic glove technique on the pain and anxiety of children during Leupromer injection Investigating the effect of the magic glove technique on the pain and anxiety of children during Leupromer injection 2024-02-20 anticipated 60 Complete https://irct.ir/trial/74978 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To assign the target group to one of the two study groups; The intervention group and the control group (group A and group B) will use the block randomization method with blocks of four. Then, the participants will be assigned to one of the two groups 1: magic glove, 2: no intervention according to the block randomization protocol (produced by Random Allocation Software) with a ratio of 1:1, In such a way, the researcher cannot predict which group of intervention the next person will be placed in. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes. N/A Condition 1: anxiety. Condition 2: pain. Intervention 1: .According to the Rel@x manual published by Aramideh et al., the magic glove technique consists of 4 steps. Step 1: Introducing the magic glove to the child "I have a magic glove to protect your arm well. Do you agree that Shall I explain to you why it is magical?" The nurse explains to the patient that the magic glove will help him change the sensations in his arm. It's important to avoid saying, "You won't feel any pain," as negative suggestions can lead to stress. Then, the nurse asks the patient to put his hand or arm in hers and suggests, "Relax in my hand." By feeling the full weight of the arm in his hand, the nurse makes sure that the patient has released his arm. The second step (applying the magic glove): The nurse asks the patient: "What kind of magic glove would you like to have? Can you Describe it to me?" He allows the patient's creativity to do this imaginative work. Then, the nurse pretends to take the magic glove described by the patient out of her pocket and place it on the patient's hand.He starts with the patient's fingers and then uses the palm of his other hand to gently stroke them up to the wrist or cubital area. The nurse ensures that the end of the glove is clearly marked with each stroke and for each finger. She performs these strokes several times while continuously talking to the child so that the patient can imagine the glove on his arm. Third stage (Desensitization): The nurse confirms the patient's sensory attention by talking about the process while putting on the magic glove. he does. "This glove protects you so you're aware of what's going on. It won't hurt you. While you're wearing the glove, you'll feel changes happening.Your arm is protected, it feels like you're going to be well protected from anything... Do you feel how protected your hand is?” The nurse repeats the same words over and over while applying the magic glove. At the end of the last stroke, the nurse gently squeezes the upper arm and says, "Here, the magic glove is in place. Now that you have your magic glove, you'll find that you won't be bothered anymore. It is going very well. It will be convenient."In this case, the nurse tests the glove to see how well this technique protects the patient. First, the nurse presses the back of the hand untouched by the magic glove 3 times with a sharp pencil and says : "This is a perfect sensation because there is no magic glove, so the score is 10 out of 10." He tests the hand with the magic glove by applying equal pressure. He asks the patient to rate the sensation out of 10. Score 5 or less is great.Now that the magic glove is in place, the nurse can administer the injection. Here, if necessary, the nurse adds another focus by asking the patient to talk about the magic glove and describe it. During the injection, he reminds the patient: "Notice how this glove protects you!" He continues to stroke the arm to adjust the glove if necessary.The fourth stage (end of treatment): After the injection, the nurse removes the magic glove. He does this by stroking the arm in the opposite direction to make sure full sensation has returned to the patient's hand. He asks the patient to rub his hands as if he were washing them to normalize his feelings. This should be continued until the patient confirms that sensation has returned. Intervention 2: Control group: Without intervention, only injection is done. 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 There is no further information
public Faezeh Rostamian
Dr. Mirkhani St, Tawheed Square
تهران Iran (Islamic Republic of) 3565416546 +98 21 6692 7171 faezeh78rostamian@gmail.com Tehran University of Medical Sciences scientific Faezeh Rostamian
Dr. Mirkhani St, Tawheed Square
Tehran Iran (Islamic Republic of) 3565416546 +98 21 6692 7171 faezeh78rostamian@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Having mental health and alertness Being healthy in terms of hearing No pain caused by the disease Have the experience of Leupromer injection (1 or more injections have been done for them). Boys and girls 3-12 years old 3 years 12 years Both Receiving a sedative, pain reliever or anti-anxiety medication Any life-threatening emergency A score greater than 5 in reducing the child's pain in the desensitization stage of the magic glove technique F93.1 R52.0 Phobic anxiety disorder of childhood Acute pain Behavior N/A .According to the Rel@x manual published by Aramideh et al., the magic glove technique consists of 4 steps. Step 1: Introducing the magic glove to the child "I have a magic glove to protect your arm well. Do you agree that Shall I explain to you why it is magical?" The nurse explains to the patient that the magic glove will help him change the sensations in his arm. It's important to avoid saying, "You won't feel any pain," as negative suggestions can lead to stress. Then, the nurse asks the patient to put his hand or arm in hers and suggests, "Relax in my hand." By feeling the full weight of the arm in his hand, the nurse makes sure that the patient has released his arm. The second step (applying the magic glove): The nurse asks the patient: "What kind of magic glove would you like to have? Can you Describe it to me?" He allows the patient's creativity to do this imaginative work. Then, the nurse pretends to take the magic glove described by the patient out of her pocket and place it on the patient's hand.He starts with the patient's fingers and then uses the palm of his other hand to gently stroke them up to the wrist or cubital area. The nurse ensures that the end of the glove is clearly marked with each stroke and for each finger. She performs these strokes several times while continuously talking to the child so that the patient can imagine the glove on his arm. Third stage (Desensitization): The nurse confirms the patient's sensory attention by talking about the process while putting on the magic glove. he does. "This glove protects you so you're aware of what's going on. It won't hurt you. While you're wearing the glove, you'll feel changes happening.Your arm is protected, it feels like you're going to be well protected from anything... Do you feel how protected your hand is?” The nurse repeats the same words over and over while applying the magic glove. At the end of the last stroke, the nurse gently squeezes the upper arm and says, "Here, the magic glove is in place. Now that you have your magic glove, you'll find that you won't be bothered anymore. It is going very well. It will be convenient."In this case, the nurse tests the glove to see how well this technique protects the patient. First, the nurse presses the back of the hand untouched by the magic glove 3 times with a sharp pencil and says : "This is a perfect sensation because there is no magic glove, so the score is 10 out of 10." He tests the hand with the magic glove by applying equal pressure. He asks the patient to rate the sensation out of 10. Score 5 or less is great.Now that the magic glove is in place, the nurse can administer the injection. Here, if necessary, the nurse adds another focus by asking the patient to talk about the magic glove and describe it. During the injection, he reminds the patient: "Notice how this glove protects you!" He continues to stroke the arm to adjust the glove if necessary.The fourth stage (end of treatment): After the injection, the nurse removes the magic glove. He does this by stroking the arm in the opposite direction to make sure full sensation has returned to the patient's hand. He asks the patient to rub his hands as if he were washing them to normalize his feelings. This should be continued until the patient confirms that sensation has returned Control group: Without intervention, only injection is done. Child anxiety. Timepoint: Before the start of the intervention and after the end of the injection. Method of measurement: A revised anxiety behavioral observational instrument. Child's pain. Timepoint: After the end of the injection. Method of measurement: Wong Baker Tool. Research Assistant, Tehran University of Medical Sciences Approved 2023-12-16 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o Tehran University of Medical Sciences Central Building, intersection of Qods St.,Keshavarz Boulevard tehran Tehran Iran (Islamic Republic of)