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

NCT04692584 | Completed

• 1 other identifier: Mehmet Akif Ersoy University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

Anxiety; Pain; Vaccination; Mother; Nursing

Outcome Measures

Primary Outcomes (2)

• Neonatal Infant Pain Scale (NIPS)

  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.

  6 MONTHS

• State Anxiety Inventory (SAI)

  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.

  6 MONTHS

Secondary Outcomes (3)

• Heart Rate

  6 MONTHS

• Oxygen Saturation

  6 MONTHS

• Crying duration of babies

  6 MONTHS

Study Arms (2)

The Lullaby Group

EXPERIMENTAL

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.

Behavioral: The Lullaby Group

Control Group

NO INTERVENTION

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.

Interventions

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.

The Lullaby Group

Eligibility Criteria

• Age: 2 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, Turkey (Türkiye)

Location

Related Publications (1)

• Bekar P, Efe E. Effects of mother-sung lullabies on vaccination-induced infant pain and maternal anxiety: A randomized controlled trial. J Pediatr Nurs. 2022 Jul-Aug;65:e80-e86. doi: 10.1016/j.pedn.2022.03.003. Epub 2022 Mar 25.

  PMID: 35341657 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Emine EFE, Prof.Dr.

  Akdeniz University, Department of Child Health and Disease Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The video recordings were evaluated by two academicians in the field of child health and disease nursing, including a researcher and a research assistant with a doctorate in child health and disease nursing who were not blinded to the group assignment. For each assessment, the observers watched the videos of the babies and conducted NIPS assessments during and after the intervention. These observers were blinded to the other's observations and did not discuss the scores.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This was an experimental, randomized controlled study. These babies were randomly assigned to one of two groups, including 30 babies in the lullaby group and 30 babies in the control group. Randomization was performed using a sealed envelope method. The video recordings were evaluated by two academicians in the field of child health and disease nursing, including a researcher and a research assistant with a doctorate in child health and disease nursing who were not blinded to the group assignment. These observers were blinded to the other's observations and did not discuss the scores.

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 5, 2021
• Study Start: March 4, 2020
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: December 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)