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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04692584
Enrollment
60
Registered
2021-01-05
Start date
2020-03-04
Completion date
2020-08-28
Last updated
2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain

Keywords

Anxiety, Pain, Vaccination, Mother, Nursing

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.

Interventions

BEHAVIORALThe 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.

Sponsors

Mehmet Akif Ersoy University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

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.

Eligibility

Sex/Gender
ALL
Age
2 Months to 2 Months
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.

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Infant Pain Scale (NIPS)6 MONTHSNeonatal 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 MONTHSThe 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

MeasureTime frameDescription
Heart Rate6 MONTHSHeart 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 Saturation6 MONTHSOxygen 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 babies6 MONTHSThe crying time was expressed in seconds. The cry time measured up to 30 seconds after vaccination was the total cry time (using video seconds).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026