Preterm BirthNCT04886648
THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
A study testing Music Therapy in people with Preterm Birth, run by TC Erciyes University.
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. Read more about this study
- Who is it for?
- Ages 32 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 14 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Premature babies who do not meet the inclusion criteria.
- -
About this study
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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Music Therapy
- Keywords
- Mother's voice, lullaby, preterm newborn, stress, sleep-wakefulness state
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mother Voıce | Experimental | Premature baby group with mother voıce application. Receives: Behavioral: Music Therapy |
| Lullably | Experimental | Premature baby group with lullably application. Receives: Behavioral: Music Therapy |
| Control | No intervention | Premature baby group with no application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Mar 2014
- Primary completion28 Mar 2014
- Study completion14 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted in a randomized controlled manner.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Deri̇nce Eryuruk, TC Erciyes University
- Investigators
- DİLEK ERYÜRÜK, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886648
- Sponsor's protocol ID
- Eryuruk
- Status last verified
- May 2021
- First submitted
- 5 Apr 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal data will not be shared because it was promised in the study when consent was obtained from the participants.
Publications
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.
PubMed 30826725Peng 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.
PubMed 24092866Liaw 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.
PubMed 23068310Alipour 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.
PubMed 23890458Keith 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.
PubMed 19757875
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE
- ClinicalTrials.gov ID
- NCT04886648
- Acronym / sponsor ID
- Eryuruk
- Conditions
- Preterm Birth
- Keywords
- Mother's voice, lullaby, preterm newborn, stress, sleep-wakefulness state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 28 Mar 2014 (actual)
- Study completion
- 14 Apr 2016 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study will be conducted in a randomized controlled manner.
| Arm | Type | Receives |
|---|---|---|
| Mother Voıce | Experimental | Behavioral: Music TherapyPremature baby group with mother voıce application. |
| Lullably | Experimental | Behavioral: Music TherapyPremature baby group with lullably application. |
| Control | No intervention | –Premature baby group with no application |
Who may qualify
- Ages
- 32 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (2 listed)
- Premature babies who do not meet the inclusion criteria.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Therapy | Behavioural | Lullably, Mother Voıce |
Primary outcome
Newborn Stress Evaluation Form (NSEF)
Time frame: NSEF was measured on days 1 through 5, which had a 5-day application period.
NSEF, there is no stress indicator '0', mild stress indicators' 1 ', moderate stress indicators' 2', and severe stress indicators'. It is scored as 3.
1 secondary outcome
Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF)
Time frame: NSWEF NSEF was measured on days 1 through 5, which had a 5-day application period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Results publication: PubMed 30826725Robertson 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.
- Results publication: PubMed 24092866Peng 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.
- Results publication: PubMed 23068310Liaw 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.
- Results publication: PubMed 23890458Alipour 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.
- Results publication: PubMed 19757875Keith 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.
- Individual participant dataSharing planned: No. Personal data will not be shared because it was promised in the study when consent was obtained from the participants.
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DİLEK ERYÜRÜK principal investigator
Study Principal Investigator
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Preterm Birth, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Stress Evaluation Form (NSEF) (time frame: NSEF was measured on days 1 through 5, which had a 5-day application period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886648, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.