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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231014059712N1

Enrollment

Registered

2023-11-12

Start date

2023-11-13

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children undergoing surgery for congenital heart disease. Congenital malformations of cardiac chambers and connections

Interventions

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 op

Eligibility

Sex/Gender

All

Age

1 Months to 5 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Having Neurogenic Developmental Disorders Hearing Impairment Previous Surgical History

Design outcomes

Primary

Measure	Time frame
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.;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.	—

Measure

Time frame

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.;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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Dalir

Mashhad University of Medical Sciences

dalirz@mums.ac.ir+98 51 3859 1511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026