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

Sponsor

Mehmet Akif Ersoy University (Other)

Overall Status

Completed

CT.gov ID

NCT04692584

Collaborator

(none)

Enrollment

Location

Arms

5.8

Actual Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Anxiety	Behavioral: The Lullaby Group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 4, 2020

Actual Primary Completion Date :

Aug 28, 2020

Actual Study Completion Date :

Aug 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: The Lullaby Group 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.
No Intervention: Control Group 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: The Lullaby Group

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.

No Intervention: Control Group

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.

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 2 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burdur Mehmet Akif Ersoy University	Burdur		Turkey

Sponsors and Collaborators

Mehmet Akif Ersoy University

Investigators

Study Director: Emine EFE, Prof.Dr., Akdeniz University, Department of Child Health and Disease Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pınar BEKAR, Assistant Professor, Mehmet Akif Ersoy University

ClinicalTrials.gov Identifier:

NCT04692584

Other Study ID Numbers:

Mehmet Akif Ersoy University

First Posted:

Jan 5, 2021

Last Update Posted:

Dec 3, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pınar BEKAR, Assistant Professor, Mehmet Akif Ersoy University

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Dec 3, 2021