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

NCT04886648 | Completed

• 1 other identifier: Eryuruk
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preterm Birth

Keywords

Mother's voice; lullaby; preterm newborn; stress; sleep-wakefulness state

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF)

  NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.

Other Outcomes (3)

• Heart Rate

  Heart rate was measured on days 1 through 5, which had a 5-day application period.

• Respiratory Rate

  Respiratory rate was measured on days 1 through 5, which had a 5-day application period.

• Oxygen Saturation

  Oxygen saturation was measured on days 1 through 5, which had a 5-day application period.

Study Arms (3)

Mother Voıce

EXPERIMENTAL

Premature baby group with mother voıce application.

Behavioral: Music Therapy

Lullably

EXPERIMENTAL

Premature baby group with lullably application.

Behavioral: Music Therapy

Control

NO INTERVENTION

Premature baby group with no application

Interventions

Music Therapy BEHAVIORAL

Lullably; Mother Voıce

Eligibility Criteria

• Age: 32 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• /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

Sponsors & Collaborators

• TC Erciyes University: lead

Related Publications (5)

• 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.

  PMID: 30826725 RESULT

• 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.

  PMID: 24092866 RESULT

• 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.

  PMID: 23068310 RESULT

• 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.

  PMID: 23890458 RESULT

• 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.

  PMID: 19757875 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• DİLEK ERYÜRÜK

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Video footage in the study was made by three experts. Experts blindly evaluated the groups to which the videos they evaluated belonged to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be conducted in a randomized controlled manner.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: May 14, 2021
• Study Start: March 1, 2014
• Primary Completion: March 28, 2014
• Study Completion: April 14, 2016
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share