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

NCT ID: NCT04692584

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-04

Study Completion Date

2020-08-28

Brief Summary

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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

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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.

Conditions

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Pain Anxiety

Keywords

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Anxiety Pain Vaccination Mother Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

The Lullaby Group

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mehmet Akif Ersoy University

OTHER

Sponsor Role lead

Responsible Party

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Pınar BEKAR

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine EFE, Prof.Dr.

Role: STUDY_DIRECTOR

Akdeniz University, Department of Child Health and Disease Nursing

Locations

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Burdur Mehmet Akif Ersoy University

Burdur, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 35341657 (View on PubMed)

Other Identifiers

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Mehmet Akif Ersoy University

Identifier Type: -

Identifier Source: org_study_id