The Effect Of Lullaby Records Sung By The Parent's During Newborn Care On Newborn's

• Sponsor: Kocaeli University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04942587
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 3
• Actual Duration (Months): 9.7
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes. The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes. Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care. The data was evaluated in SPSS 21.0 program with convenient statistical methods.İt is detected that heart rate, respiration rateand comfort behiavour scores of the newborns who listen to lullaby in the mother's voice are low compared to the newborns listening to lullaby in the father's voice and those in the control group .

Condition or Disease	Intervention/Treatment	Phase
Comforf, Procedural (During Newborn Care İn Newborn's); Physiological Parameters During Newborn Care İn Newborn's	Behavioral: LISTENING TO THE RECORDINGS SAYING BY PARENTS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect Of Lullaby Records Sung By The Parent's During Newborn Care On Newborn's And Physical Parameters In Newborn Intensive Care Unit
• Actual Study Start Date: Apr 1, 2018
• Actual Primary Completion Date: Apr 5, 2018
• Actual Study Completion Date: Jan 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mother's voices Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes. The baby was made listen to the lullaby recorded in the voice of mother's starting with, during and after the care for 10 minutes. Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.	Behavioral: LISTENING TO THE RECORDINGS SAYING BY PARENTS; The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
Experimental: father's voices group Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes. The baby was made listen to the lullaby recorded in the voice of father's starting with, during and after the care for 10 minutes. Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.	Behavioral: LISTENING TO THE RECORDINGS SAYING BY PARENTS; The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
No Intervention: control group Standard nursing care including, eye, mouth, nose, diaper change, skin care with baby oil and nurturing was applied respectively to the study groups for approximately 20 minutes.Heart rate, saturation, respiration rate and comfort behiavour scores of the newborn was measured 1 minutes before, during and 15 minutes after the care.

Outcome Measures

Primary Outcome Measures

1. The effect of lullaby records sung by the parent's during newborn care on newborns comfort in newborn intensive care unit. [35 minute]

   Newborn comfort behavior scale was used for determinain Comfort behiavour scores in this research. Scale got 0 to 35 points (0 (Good) to 35 (Bad).

2. The effect of lullaby records sung by the parent's during newborn care on newborns on the heart beat in newborn intensive care unit. [35 minute]

   heart beat- bpm

3. The effect of lullaby records sung by the parent's during newborn care on newborns on the respiration rate in newborn intensive care unit. [35 minute]

   respiration rate

4. The effect of lullaby records sung by the parent's during newborn care on newborns on the SpO2 in newborn intensive care unit. [35 minute]

   ects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing SpO2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Weeks to 37 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Premature babies at 30-37 weeks of gestation,

• There is no congenital anomaly affecting respiration and spontaneous respiration,

• No intubation,

• Absence of congenital or acquired malfarmation related to hearing,

• Absence of hyperbilirubinemia requiring exchange transfusion,

• Absence of intrauterine infection (rubella, syphilis, toxoplasma),

• Absence of intracranial bleeding,

• No sedative, opioid and anticonvulsant drugs were given before/during the study,

• Parents' consent to participate in the study,

Exclusion Criteria:

• Having a diagnosis of asphyxia,

• Congenital hearing problems in family members,

• Intubating the baby after starting the research,

• Parents have a speech impediment,

• Parents have psychological problems,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kocaeli Hospital	Kocaeli	Izmit	Turkey	41000

Sponsors and Collaborators

• Kocaeli University

Investigators

• Principal Investigator: Duygu Akyüz, [e-mail]
• Principal Investigator: Gülzade Uysal, gü[e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duygu Akyuz, Principal Investigator, Kocaeli University
• ClinicalTrials.gov Identifier: NCT04942587
• Other Study ID Numbers: KÜ GOKAEK 2018/90
• First Posted: Jun 28, 2021
• Last Update Posted: Jun 29, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duygu Akyuz, Principal Investigator, Kocaeli University: Mother's voice; Father's voice; Lullaby; Comfort; Physiological Parameters

Study Results

No Results Posted as of Jun 29, 2021