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

Not Applicable

Completed

• Conditions: Pain; Anxiety
• Interventions: Behavioral: The Lullaby Group

• Registration Number: NCT04692584
• Lead Sponsor: Mehmet Akif Ersoy University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-03-04
• Primary Completion: 2020-08-28
• Study Completion: 2020-08-28
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-11-20
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Lullaby Group	The Lullaby Group	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.

Primary Outcome Measures

Name	Time	Method
State Anxiety Inventory (SAI)	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.
Neonatal Infant Pain Scale (NIPS)	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.

Secondary Outcome Measures

Name	Time	Method
Oxygen Saturation	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.
Heart Rate	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.
Crying duration of babies	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).

Trial Locations

Locations (1)

Burdur Mehmet Akif Ersoy University; 🇹🇷 Burdur, Turkey