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

Mehmet Akif Ersoy University

Status: Completed

Conditions: Anxiety; Pain

Treatments: Behavioral: The Lullaby Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04692584

Mehmet Akif Ersoy University

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 2 to 2 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

The Lullaby Group

Experimental group

Description:

In this group, their mothers sang a lullaby during the vaccination process. Each mother touched her baby's hands and body while singing a lullaby and hugged her baby after the procedure.

Treatment:

Behavioral: The Lullaby Group

Control Group

No Intervention group

Description:

In this group, their mothers did not sing a lullaby during the vaccination process. Mothers touched their infant's hands and body and talk to their infants during and after vaccination. Mothers hugged their infant after the procedure.