Clinical trial NCT04886648: THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
Official title: THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Mother's voice
lullaby
preterm newborn
stress
sleep-wakefulness state
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 90
Sex: ALL
Minimum age (years): 32
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted in a randomized controlled manner.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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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Primary outcomes:
measure: Newborn Stress Evaluation Form (NSEF)
timeFrame: NSEF was measured on days 1 through 5, which had a 5-day application period.
Secondary outcomes:
measure: Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF)
timeFrame: NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.
Other outcomes:
measure: Heart Rate
timeFrame: Heart rate was measured on days 1 through 5, which had a 5-day application period.
measure: Respiratory Rate
timeFrame: Respiratory rate was measured on days 1 through 5, which had a 5-day application period.
measure: Oxygen Saturation
timeFrame: Oxygen saturation was measured on days 1 through 5, which had a 5-day application period.
Locations:
Study officials:
affiliation: Study Principal Investigator
name: DİLEK ERYÜRÜK
role: PRINCIPAL_INVESTIGATOR
References:
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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: 10.1177/1367493513496665. Epub 2013 Oct 3.
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 Stud. 2013 Jul;50(7):883-94. doi: 10.1016/j.ijnurstu.2012.08.021. Epub 2012 Oct 12.
citation: 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.2013.02.007. Epub 2013 May 9.
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. doi: 10.1093/jmt/46.3.191.