Effects of Mother-Sung Lullabies on Infant Pain and Maternal Anxiety
Primary Purpose
Pain, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Lullaby Group
Sponsored by

About this trial
This is an interventional prevention trial for Pain focused on measuring Anxiety, Pain, Vaccination, Mother, Nursing
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.
Sites / Locations
- Burdur Mehmet Akif Ersoy University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The Lullaby Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Heart Rate
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
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
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).
Full Information
NCT ID
NCT04692584
First Posted
December 22, 2020
Last Updated
November 20, 2021
Sponsor
Mehmet Akif Ersoy University
1. Study Identification
Unique Protocol Identification Number
NCT04692584
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
August 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mehmet Akif Ersoy University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Anxiety, Pain, Vaccination, Mother, Nursing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
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.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Lullaby Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Lullaby Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neonatal Infant Pain Scale (NIPS)
Description
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.
Time Frame
6 MONTHS
Title
State Anxiety Inventory (SAI)
Description
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.
Time Frame
6 MONTHS
Secondary Outcome Measure Information:
Title
Heart Rate
Description
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.
Time Frame
6 MONTHS
Title
Oxygen Saturation
Description
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.
Time Frame
6 MONTHS
Title
Crying duration of babies
Description
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).
Time Frame
6 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine EFE, Prof.Dr.
Organizational Affiliation
Akdeniz University, Department of Child Health and Disease Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Burdur Mehmet Akif Ersoy University
City
Burdur
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35341657
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.
Results Reference
derived
Learn more about this trial
Effects of Mother-Sung Lullabies on Infant Pain and Maternal Anxiety
We'll reach out to this number within 24 hrs