Back to resultsEffect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection
Primary Purpose
Pain, Infant, Newborn, Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Listening the maternal heart sound during the invasive interventions
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Pain, Newborn, Non-Drug Pain Management
Eligibility Criteria
Inclusion Criteria:
- Gestational age of 38-41 weeks,
- Chronological age of 2-28 days,
- Without any physical, metabolic or genetic disease,
- Newborns who did not use any analgesic drugs before the procedure
Exclusion Criteria:
- Newborns whose heel blood cannot be taken at once
Sites / Locations
- Pendik Mehmet Oguz Family Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Experimental Group
Arm Description
Routine heel blood was taken from the control group. At the same time, the behaviors of newborns were recorded on camera throughout the procedure. At the end of the study, the camera recording was watched and scored by two midwives who had training in the Neonatal Pain Scale.
The newborns in the experimental group listened to the recorded heart sounds of their mothers for 1 minute before the heel blood procedure, during the procedure and for 1 minute after the procedure. At the same time, the behaviors of newborns were recorded on camera throughout the procedure. At the end of the study, the camera recording was monitored and scored by two midwives trained in the Neonatal Pain Scale.
Outcomes
Primary Outcome Measures
The Newborn Infant Pain Scale (NIPS)
The Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain.
Secondary Outcome Measures
Full Information
NCT ID
NCT05520164
First Posted
August 25, 2022
Last Updated
August 31, 2022
Sponsor
Saglik Bilimleri Universitesi
Collaborators
Pendik District Health Directorate
1. Study Identification
Unique Protocol Identification Number
NCT05520164
Brief Title
Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection
Official Title
Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi
Collaborators
Pendik District Health Directorate
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
This study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.
Detailed Description
The randomized controlled and experimental study was conducted with 60 newborns applied to a public family health center for heel blood collection. The infants in the experimental group (n=30) were listened to the maternal heart sound before, during, and after the heel blood collection procedure, and routine blood collection was applied to the control group (n=30). Newborn Information Form and Newborn Infant Pain Scale (NIPS) were used to collect data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Infant, Newborn, Disease
Keywords
Pain, Newborn, Non-Drug Pain Management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a randomized controlled trial.
Masking
Outcomes Assessor
Masking Description
The two separate clinicians conducting the assessment were masked to allow for impartiality.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine heel blood was taken from the control group. At the same time, the behaviors of newborns were recorded on camera throughout the procedure. At the end of the study, the camera recording was watched and scored by two midwives who had training in the Neonatal Pain Scale.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The newborns in the experimental group listened to the recorded heart sounds of their mothers for 1 minute before the heel blood procedure, during the procedure and for 1 minute after the procedure. At the same time, the behaviors of newborns were recorded on camera throughout the procedure. At the end of the study, the camera recording was monitored and scored by two midwives trained in the Neonatal Pain Scale.
Intervention Type
Other
Intervention Name(s)
Listening the maternal heart sound during the invasive interventions
Intervention Description
Heart sounds of the newborns' own mothers were recorded on the voice recorder with the help of a hand doppler device. This sound was listened by the newborns in the experimental group during the heel blood procedure.
Primary Outcome Measure Information:
Title
The Newborn Infant Pain Scale (NIPS)
Description
The Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain.
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Gestational age of 38-41 weeks,
Chronological age of 2-28 days,
Without any physical, metabolic or genetic disease,
Newborns who did not use any analgesic drugs before the procedure
Exclusion Criteria:
Newborns whose heel blood cannot be taken at once
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sümeyye KOSE, Phd Student
Organizational Affiliation
Pendik District Health Directorate
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Besey OREN, Associate Prof
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Director
Facility Information:
Facility Name
Pendik Mehmet Oguz Family Health Center
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://doi.org/10.5430/jnep.v5n4p32
Description
Effect of interactive distraction versus cutaneous stimulation for venipuncture pain relief in school age children.
URL
https://doi.org/10.1016/j.ctcp.2017.05.008
Description
Effect of inhalation aromatherapy with lavender essence on pain associated with intravenous catheter insertion in preschool children: a quasi-experimental study. Com
URL
https://doi.org/10.1089/acm.2020.0327
Description
Pain control with lavender oil in premature infants: a double-blind randomized controlled study. The Journal of Alternative and Complementary Medicine, 27(2), 136-141.
Learn more about this trial
Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection
We'll reach out to this number within 24 hrs