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Completed

NCT Number: NCT04692584

Effects of Mother-Sung Lullabies on Infant Pain and Maternal Anxiety

Childhood pain can cause long-term and psychologically harmful effects. Music can reduce pain and anxiety. This study aimed to investigate the effects of the mother-sung lullaby during vaccine administration on vaccine-induced pain in babies and anxiety in mothers.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 month–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burdur Mehmet Akif Ersoy University

Burdur, Turkey (Türkiye)

About this study

This study aimed to investigate the effects of the mother-sung lullaby during vaccine administration on vaccine-induced pain in babies and anxiety in mothers. Two family health centers in Turkey between March 4, 2020, and August 28, 2020. A total of 60 babies who received the Bacille Calmette-Guérin vaccine and their mothers.These babies were randomly assigned to one of two groups, including 30 babies in the lullaby group and 30 babies in the control group. Data on descriptive information for all babies and mothers were collected through face-to-face interviews with the mothers before vaccination. Heart rate, oxygen saturation, and crying duration were measured in all babies. Heart rate and oxygen saturation of the babies were recorded using a pulse oximeter during and after vaccine administration. The crying time, measured for up to 30 seconds after vaccination, was recorded as the total cry time (using video seconds). The pain score was evaluated by two observers using the Neonatal Infant Pain Scale, based on video recordings obtained during and after vaccine administration. In addition, mothers' anxiety scores were measured using the "State Anxiety Inventory," both before and after vaccination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gestational age of 37-42 weeks
  • postnatal age at full two month
  • receiving the Bacille Calmette-Guérin vaccine
  • birth weight of 2500 gr or higher
  • no congenital anomalies
  • stable general condition
  • not taking any pain medication before vaccination
  • mothers were required to be older than 18 years and agree to participate in the study

Exclusion criteria

  • taking analgesic medication within 4 hours before the procedure
  • parents not willing to participate in research.

Treatment and study plan

The Lullaby Group

Behavioral

Approximately 15 seconds before the vaccination, each baby's mother began to sing a lullaby. Infant's mother continued to sing lullabies until all the vaccinations, which were given immediately after the BCG vaccination, were completed. Each mother touched her baby's hands and body while singing a lullaby and hugged her baby after the procedure. All the mothers sang the same lullaby, "Sleep and Grow". Mothers were reminded of the words to the lullaby before vaccine administration.

Primary outcomes

  1. Neonatal Infant Pain Scale (NIPS)

    Time frame: 6 MONTHS

    Neonatal Infant Pain Scale (NIPS) was used for the pain assessment. The NIPS consists of 6 behavioral sections, including facial expression, crying, breathing pattern, arm and leg movements, and wakefulness. Although 2 point values (0-1 point) can be scored for behaviors other than crying, 3 point values (0-1-2 points) are scored for crying. The total score ranges from 0 to 7, with higher scores indicated increased pain intensity.

  2. State Anxiety Inventory (SAI)

    Time frame: 6 MONTHS

    The SAI was used in this study, which can be used to determines how an individual feels at a certain time and under certain conditions. The SAI consists of 20 questions, with scores ranging from 20-80. A high score indicates high anxiety, whereas a low score indicates low anxiety. The State Anxiety Inventory was used to determine the anxiety levels of the mothers before and after the vaccine administration.

Secondary outcomes

  1. Heart Rate

    Time frame: 6 MONTHS

    Heart rate of the babies were recorded using a pulse oximeter placed on the right or left foot or hand of each baby before the intervention. Heart rate levels were recorded during and after vaccination.

  2. Oxygen Saturation

    Time frame: 6 MONTHS

    Oxygen saturation of the babies were recorded using a pulse oximeter placed on the right or left foot or hand of each baby before the intervention. Oxygen saturation levels were recorded during and after vaccination.

  3. Crying duration of babies

    Time frame: 6 MONTHS

    The crying time was expressed in seconds. The cry time measured up to 30 seconds after vaccination was the total cry time (using video seconds).

Sponsors and collaborators

Lead sponsor

Mehmet Akif Ersoy University

Other

Registry information

Official study title

Effects of Mother-Sung Lullabies on Vaccination-Induced Infant Pain and Maternal Anxiety

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2021
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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