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IRCT20231014059712N1 IRCT 2023-11-12 Mashhad University of Medical Sciences The Effect of Mother's Recorded Voice on Pain Intensity And Vital Signs of Children Undergoing Surgery for Congenital Heart Disease Evaluation The Effect of Mother's Recorded Voice Compared To Routine Care on Pain Intensity and Physiological Indicators in Children Undergoing Surgery for Congenital Heart Disease 2023-11-13 anticipated 72 Complete https://irct.ir/trial/73154 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Regarding the method of recording the voice, it is explained to the mother that her voice will be recorded at a time of the day in the rooms of the department (open heart surgery in Imam Reza Hospital) which is quiet and appropriate. In this way, the mother is asked to express the words and sentences she uses to calm her child. Audio content can include free conversations with the child or the child's favorite poems. The mother's voice is recorded by the researcher using a mobile recorder for 5 minutes. Then, on the next day, after the end of the surgery, the sound recorded using the researcher's mobile phone is played next to the child's ear at several time points: first, when the child enters the open heart ICU, and then every two hours until 6 hour and then every four hours until 24 hours (or until the mother is in the ICU). Measurement of pain level and physiological indicators (heart rate, breathing, systolic/diastolic blood pressure, SPO2) first at the time of entering the ICU (baseline data), then before the start of each intervention and also 15 minutes after each time playing the sound with FLACC (Face, Legs, Activity, Crying and Consolation) modified behavioral scale of pain is used and the values of physiological indicators are measured and recorded in the relevant form using the monitoring available in the open heart ICU, Randomization description: Random allocation will be done in such a way that people will be divided into two groups through the PASS 11 software using blocks of size four. In this way, after determining the sequence, we put them in the envelopes and number them in order. Mothers take the envelope in the order of their entry into the study and are placed in the intervention or control group. N/A Children undergoing surgery for congenital heart disease. Intervention 1: Intervention group: in this group, in addition to the routine medical treatment, the mother's recorded voice next to the child's ear using a mobile phone, when the child entered the open-heart ICU, and then every two hours up to 6 hours, and then every four hours. It is played for up to 24 hours (or until the mother is in the ICU). The level of pain and physiological indicators (heart rate, respiration, systolic/diastolic blood pressure, SaO2) at the time of admission to the ICU (baseline data), before the start of each intervention and also 15 minutes after each time playing the sound using a behavioral scale. Adjusted pain FLACC (face, legs, activity, crying and consolation) is measured and the values of physiological indicators are measured using the monitoring available in the open heart ICU department and recorded in the relevant form. Intervention 2: Control group: In this group, the usual care, which includes routine drug therapy, is performed. These drugs include Dexmedetomidine: 0.2-0.5 mcg/kg/h, Fentanyl: 2-0.5 mcg/kg/h, Midazolam. : 0.5 mcg/kg/min, Ceftazidime: 30-50 mg/kg q8h, Vancomycin: 10mg/kg, Magnesium Sulfate: 15-50mg/kg q4-6h, Potassium Chloride: 0.5meq/kg/h, every 12 hours. Pain scale and physiological indicators are measured at the same time as the intervention group. Yes - There is a plan to make this available What will be shared: All the data obtained from this research will be shared after completion. When: Access to the data will be possible 3 months after the results are published. To whom: These data will be used for researchers working in academic and scientific institutions, as well as for parents with children with congenital heart disease. Conditions: The data obtained from this research can be used in other scientific studies. Where to obtain: Copying (in any way) either from the full text or from the extracts is possible only with the coordination of the supervisor and the registered author and according to the instructions provided by the Central Library of Mashhad University of Medical Sciences. Details can be accessed through the relevant faculty library. The use of the thesis in articles or any scientific writing is subject to citing the source in compliance with the Mashhad University of Medical Sciences publishing regulations. Zahra Sadegh Al-Hosseini Sadeghhz992@mums.ac.ir How to obtain: The applicant should send an email to the responsible author and register his request. After verifying the correctness of the information of the mentioned person, the required content will be provided to him by mentioning the source. Comments:
public Zahra Dalir
Educational Complex of Shahid Dr. Kharazmi, University Campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 dalirz@mums.ac.ir Mashhad University of Medical Sciences scientific Zahra Sadegh al-Hosseini
No. 57, Soroush 11, Farhang 10, Farhang Blvd., Jalal Al-Ahmad
Mashhad Iran (Islamic Republic of) 9188875816 +98 51 3606 8913 sadeghhz992@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Mother's Consent to Participate in the Research Child Undergoing Surgery for Congenital Heart Disease The Age of the Child is Between 2 Months and 5 Years 1 month 5 years Both Having Neurogenic Developmental Disorders Hearing Impairment Previous Surgical History Q20 Congenital malformations of cardiac chambers and connections Treatment - Other Treatment - Other Intervention group: in this group, in addition to the routine medical treatment, the mother's recorded voice next to the child's ear using a mobile phone, when the child entered the open-heart ICU, and then every two hours up to 6 hours, and then every four hours. It is played for up to 24 hours (or until the mother is in the ICU). The level of pain and physiological indicators (heart rate, respiration, systolic/diastolic blood pressure, SaO2) at the time of admission to the ICU (baseline data), before the start of each intervention and also 15 minutes after each time playing the sound using a behavioral scale. Adjusted pain FLACC (face, legs, activity, crying and consolation) is measured and the values of physiological indicators are measured using the monitoring available in the open heart ICU department and recorded in the relevant form. Control group: In this group, the usual care, which includes routine drug therapy, is performed. These drugs include Dexmedetomidine: 0.2-0.5 mcg/kg/h, Fentanyl: 2-0.5 mcg/kg/h, Midazolam. : 0.5 mcg/kg/min, Ceftazidime: 30-50 mg/kg q8h, Vancomycin: 10mg/kg, Magnesium Sulfate: 15-50mg/kg q4-6h, Potassium Chloride: 0.5meq/kg/h, every 12 hours. Pain scale and physiological indicators are measured at the same time as the intervention group. Intensity of Pain. Timepoint: Pain Intensity is Measured at the Time of Entering the ICU (Baseline Data), Before the Start of each Intervention and also 15 Minutes after each Time the Mother's Voice is Played. Method of measurement: FLACC Modified Behavioral Pain Scale (Face, Legs, Activity, Cry, Consolability). Heart Rate. Timepoint: Heart Rate is Measured at the Time of Entering the ICU (Baseline Data), Before the Start of each Intervention and also 15 Minutes after each Time the Mother's Voice is Played Using the Monitoring Device in the Ward. Method of measurement: This variable is recorded as number per minute (heart rate and breathing) using "SADAT" Cardiac Monitoring Device. Respiration. Timepoint: Respiration is Measured at the Time of Entering the ICU (Baseline Data), Before the Start of each Intervention and also 15 Minutes after each Time the Mother's Voice is Played Using the Monitoring Device in the Ward. Method of measurement: This variable is recorded as numbers per minute using the "SADAT" Cardiac Monitoring device. Systolic/Diastolic Blood Pressure. Timepoint: Systolic/Diastolic Blood Pressure is Measured at the Time of Entering the ICU (Baseline Data), Before the Start of each Intervention and also 15 Minutes after each Time the Mother's Voice is Played Using the Monitoring Device in the Ward. Method of measurement: This variable is measured and recorded by the Oscillometric Method by tying the Sphygmomanometer Cuff to the child's arm using a Cardiac Monitoring Device, and its unit is Millimeters of Mercury. Oxygen saturation (SpO2). Timepoint: SPO2 is Measured at the Time of Entering the ICU (Baseline Data), Before the Start of each Intervention and also 15 Minutes after each Time the Mother's Voice is Played Using the Monitoring Device in the Ward. Method of measurement: This variable is controlled and recorded by connecting the Pulse Oximetry Probe to the child's leg by a Heart Monitoring Device, which is shown as a Percentage. Mashhad University of Medical Sciences Approved 2023-08-15 Ethics Committee of Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences Educational Complex of Shahid Dr. Kharazmi, University Campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)