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IRCT20190603043812N1 IRCT 2019-09-08 Iran University of Medical Sciences The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety in children The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety in children 2019-09-13 anticipated 105 Complete https://irct.ir/trial/40177 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, samples are put in three groups randomly by the online application (https://www.randomizer.org/). 105 closed envelopes are offered to each child. There is a number between 1 and 105 in each envelope. Children are put in one of the three groups based on the numbers they chose, Blinding description: Researcher is not informed about type of intervention and placebo group in this way: the vaccinator is told to inform the researcher to enter the room and fill in the survey if the child is in control group; if the child is in placebo or intervention group, the device (buzzy) is put on the child’s arm, then the researcher is asked to enter the room but does not know if the device is switched on or off. N/A The effect of combined stimulation of external cold and vibration during immunization on pain and anxiety in children. Intervention 1: Intervention group: 1.Preparing Buzzy device, ice bag, and other necessary tools for vaccination. 2.Placing the ice bag under the device. 3.Selecting injection point. 4.Placing the Buzzy device near the injection point where the needle penetrates (5 cm above the penetration point). 5.The wider end of the device is put parallel to penetration point. 6.The device is fixed by the vaccinator. 7.15 seconds before vaccination, the “switch on” button on the device is pushed. 8.Vaccine injection according to the clinic’s protocol. 9.Switching off the device after injection. 10.Disinfecting the device and ice bag (if it is not disposable) using cotton and 70% alcohol. Intervention 2: placebo group: 1. Preparing buzzy device and other necessary tools for vaccination.2. Selecting injection point.3. Placing the buzzy device near the injection point where the needle penetrates (5 cm above the penetration point).4. The wider end of the device is put parallel to penetration point.5. The device is fixed by the vaccinator. 6. Vaccine injection according to the clinic’s protocol. 7. Disinfecting the device and ice bag (if it is not disposable) using cotton and 70% alcohol. Intervention 3: Control group:1. The vaccinator washes their hand with soap before injection2. Injection point must be disinfected using cotton and 70% alcohol in circle shapes and from the center outward. The vaccination should be done after complete evaporation of the alcohol.3. Previously prepared alcohol-stained cottons must not be used.4. DPT vaccine (triple vaccine) is injected in left Deltoid muscle and is done as deep tissue injection. 5. To inject the DPT vaccine, syringe size G23 is used. ** in control group, vaccination procedure will be as the clinic’s normal routine. 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 the lack of sampling, I have no decision on release yet.
public Maryam Khoshqadam
No 47, Hafez Ave., Saduqi Blvd
Qom Iran (Islamic Republic of) 3716664867 +98 25 3291 3346 mary_khoshqadam@yahoo.com Iran University of Medical Sciences scientific Sedigheh Khanjari
Nursing Care Research Center., School of Nursing and Midwifery and Medical Management and Information.,Rashid Yasimi Ave( across from Khatam Al-Anbia Hospital).,Vali Asr St (after Vanak Square),
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ 0098 21 8867613 sed.khanjari@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) The child should be conscious and not have any identified problem in mental, hearing, sight, and verbal abilities. No presence of scar, wound or damage in the point the device is put No usage of painkillers or anxiety-reducing medications in the past 8 hours No presence of cold sensitive diseases like Reynolds and local neural anesthesia. 6-year-old children who were clients of selected clinic which is under supervision of Qom University of Medical Sciences for vaccination and were qualified and eager to take part in the research. 6 years 6 years Both No toleration the device by the child during the procedure N/A N/A N/A Intervention group: 1.Preparing Buzzy device, ice bag, and other necessary tools for vaccination. 2.Placing the ice bag under the device. 3.Selecting injection point. 4.Placing the Buzzy device near the injection point where the needle penetrates (5 cm above the penetration point). 5.The wider end of the device is put parallel to penetration point. 6.The device is fixed by the vaccinator. 7.15 seconds before vaccination, the “switch on” button on the device is pushed. 8.Vaccine injection according to the clinic’s protocol. 9.Switching off the device after injection. 10.Disinfecting the device and ice bag (if it is not disposable) using cotton and 70% alcohol. placebo group: 1. Preparing buzzy device and other necessary tools for vaccination.2. Selecting injection point.3. Placing the buzzy device near the injection point where the needle penetrates (5 cm above the penetration point).4. The wider end of the device is put parallel to penetration point.5. The device is fixed by the vaccinator. 6. Vaccine injection according to the clinic’s protocol. 7. Disinfecting the device and ice bag (if it is not disposable) using cotton and 70% alcohol. Control group:1. The vaccinator washes their hand with soap before injection2. Injection point must be disinfected using cotton and 70% alcohol in circle shapes and from the center outward. The vaccination should be done after complete evaporation of the alcohol.3. Previously prepared alcohol-stained cottons must not be used.4. DPT vaccine (triple vaccine) is injected in left Deltoid muscle and is done as deep tissue injection. 5. To inject the DPT vaccine, syringe size G23 is used. ** in control group, vaccination procedure will be as the clinic’s normal routine. The score of pain in Wong-Baker Faces Pain Rating Scale. Timepoint: After vaccination, the child is asked to choose the smiley which corresponds to the severity of the pain they experienced. Supervising nurse also chooses the smiley corresponding to severity of child’s pain with a certain tool. Method of measurement: Questioner. The score of anxiety in The Children Emotional Manifestation Scale. Timepoint: This scale is completed in two steps by the supervising nurse (researcher). After choosing the group randomly and before entering the vaccination room, child’s anxiety is measured and recorded based on their emotional demonstration scale. Then the anxiety is measured and recorded immediately after disinfecting the injection point and during injection of the vaccine. Method of measurement: Questioner. Iran University of Medical Sciences Approved 2018-08-26 Iran University of Medical Sciences Hemat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)