Clinical trial NCT04692584: Effects of Mother-Sung Lullabies on Infant Pain and Maternal Anxiety
Official title: Effects of Mother-Sung Lullabies on Vaccination-Induced Infant Pain and Maternal Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Anxiety
Pain
Vaccination
Mother
Nursing
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: 6 MONTHS
measure: State Anxiety Inventory (SAI)
timeFrame: 6 MONTHS
Secondary outcomes:
measure: Heart Rate
timeFrame: 6 MONTHS
measure: Oxygen Saturation
timeFrame: 6 MONTHS
measure: Crying duration of babies
timeFrame: 6 MONTHS
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
Study officials:
affiliation: Akdeniz University, Department of Child Health and Disease Nursing
name: Emine EFE, Prof.Dr.
role: STUDY_DIRECTOR
References:
citation: 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.