THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE

Preterm Birth Clinical Trial

Official title:

THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04886648
• Other study ID #: Eryuruk
• Status: Completed
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: April 14, 2016

Study information

• Verified date: May 2021
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was planned in a randomized controlled manner in order to evaluate the effect of mother's voice and lullaby on stress and sleep-wake situations of premature babies.

Description:

Objective:This randomized controlled study was carried out to evaluate the effect of mother's voice and lullaby on preterm infants' stress and sleeping-waking states.

Study design:The study was carried out in a newborn unit in a public hospital in Turkey. In this study, 90 preterm newborn were divided into three groups equally as mother's voice (n=30), lullaby (n=30) and control groups (n=30). Data were obtained by Mother and Newborn Identification Form, Newborn Stress Evaluation Form (NSEF) and Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF). On the 1st, 3rd and 5th days of the study; Newborns' NSEF and NSWEF scores at pre-, post-study and on the fifth minutes were evaluated. Data were evaluated by using descriptive statistics, homogeneity tests, chi-square, intra-class correlation coefficent, two way of analysis on repeated measures, generalized linear model, pearson correlation analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 14, 2016
• Est. primary completion date: March 28, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Months to 36 Months

Eligibility

Inclusion Criteria:

• 32 0/6 -36 6 weeks of gestation

• Not connected to respiratory support device

• No surgical intervention

• Not receiving medical treatment other than appropriate vitamin supplements and antibiotic treatments

• Does not have a congenital or acquired malformation related to hearing,

• Can tolerate enterally given food (no NEC, digestive system and chromosomal abnormalities)

• The mother is at least a primary school graduate

• Diabetic mother without a baby • SGA and no IUGR

Exclusion Criteria:

Premature babies who do not meet the inclusion criteria.

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Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Music Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

References & Publications (5)

Alipour Z, Eskandari N, Ahmari Tehran H, Eshagh Hossaini SK, Sangi S. Effects of music on physiological and behavioral responses of premature infants: a randomized controlled trial. Complement Ther Clin Pract. 2013 Aug;19(3):128-32. doi: 10.1016/j.ctcp.20 — View Citation

Keith DR, Russell K, Weaver BS. The effects of music listening on inconsolable crying in premature infants. J Music Ther. 2009 Fall;46(3):191-203. — View Citation

Liaw JJ, Yang L, Lee CM, Fan HC, Chang YC, Cheng LP. Effects of combined use of non-nutritive sucking, oral sucrose, and facilitated tucking on infant behavioural states across heel-stick procedures: a prospective, randomised controlled trial. Int J Nurs — View Citation

Peng NH, Chen LL, Li TC, Smith M, Chang YS, Huang LC. The effect of positioning on preterm infants' sleep-wake states and stress behaviours during exposure to environmental stressors. J Child Health Care. 2014 Dec;18(4):314-25. doi: 10.1177/13674935134966 — View Citation

Robertson AM, Detmer MR. The Effects of Contingent Lullaby Music on Parent-Infant Interaction and Amount of Infant Crying in the First Six Weeks of Life. J Pediatr Nurs. 2019 May - Jun;46:33-38. doi: 10.1016/j.pedn.2019.02.025. Epub 2019 Feb 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate	During the study heart rate was recorded with the help of a pulsioxymeter.	Heart rate was measured on days 1 through 5, which had a 5-day application period.
Other	Respiratory Rate	During the study, the number of respiration of preterm newborns was counted.	Respiratory rate was measured on days 1 through 5, which had a 5-day application period.
Other	Oxygen Saturation	During the study, oxygen saturation was recorded with the help of a pulsioxymeter.	Oxygen saturation was measured on days 1 through 5, which had a 5-day application period.
Primary	Newborn Stress Evaluation Form (NSEF)	NSEF, there is no stress indicator '0', mild stress indicators' 1 ', moderate stress indicators' 2', and severe stress indicators'. It is scored as 3.	NSEF was measured on days 1 through 5, which had a 5-day application period.
Secondary	Newborn Sleeping-Waking State Evaluation Form (NSWEF)	The evaluation of the newborn status was carried out under the main headings of sleep and waking behaviors. Sleep behavior; deep sleep, light sleep and drowsy. Waking behavior is grouped under the headings of awake (extremely awake and eyelids awake), active awake and crying. As a result of the evaluation, it was decided that the behaviors of the newborn were in an organized or disorganized range, and the form was marked and scoring was created for the conditions starting from the deep sleep state to disorganized crying. In the evaluation of the data; The interpretation was made according to the state score of the newborn. It was interpreted that as the YUUDF score decreased, the sleep state of the newborns increased, and as the YUUDF score increased, the wakefulness and crying status of the newborns increased.	NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.