Infant DevelopmentNCT06191757
Effect Of Early Intervention Program Applied To Premature Infants
A study testing supported with the developmental support program in people with Infant Development and Patient Comfort, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study was conducted to evaluate the effect of singing a lullaby with compassionate touch on early comfort and later on development of developmental support program in premature infants in the neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages 1 day to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Patient Comfort, Nursing Caries
- What is being tested?
- supported with the developmental support program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2021to 18 Jul 2023
- 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 1 day to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria:Criteria for including babies in the study;
- Premature babies born as singletons at 27-0/7 - 36-6/7 weeks of gestation,
- Premature babies whose corrected age was at the 40th week of gestation (to start the developmental support program)
- Mothers could speak, read and write Turkish were included in the study.
Exclusion Criteria:The exclusion criteria for babies from the study are as follows:
- Those diagnosed with perinatal or neonatal asphyxia, those with congenital anomalies, those with Stage 3-4 intracranial or intraventricular hemorrhage,
- Those who were given sedative opioids and anticonvulsant drugs
- Whose mothers had disabilities in communication (vision, hearing, speech)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Early Intervention Program Applied To Premature Infants In The Neonatal Intensive Care Unit On Comfort And Development
Purpose: This study was conducted to evaluate the effect of singing a lullaby with compassionate touch on early comfort and later on development of developmental support program in premature infants in the neonatal intensive care unit.
H01: Singing a lullaby along with touching in the early stages of premature babies in the neonatal intensive care unit has no effect on the comfort score of the babies.
Read more
H02: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the social emotional skills of premature babies.
H03: Singing lullabies with touch to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the language skills of premature babies.
H04: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the cognitive skills of premature babies.
H05: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the motor skills of premature babies.
Read the detailed description
Materials and Methods: This study is a randomized controlled experimental study. The research was carried out in Aydın Adnan Menderes University Application and Research Hospital Neonatal Intensive Care Unit between 28 November 2021 and 18 July 2022. Premature infants at 330/7 -366/7 weeks of gestation who were hospitalized in the neonatal intensive care unit were included in the sampling. The sample consisted of n=57 premature infants, n=27 in the study group and n=30 in the control group. Data were collected in two stages. In the first stage, mothers sang lullabies to the infants in the study group three times a week and touched them tenderly. In the second stage, developmental support program (GEDEP) was applied to the same infants for three months starting from the 40th week of gestation. The infants in the control group were given routine care. In data collection, Mother and Newborn Descriptive Information Form, Premature Infant Comfort Scale (PICS), Developmental Support Program Evaluation Form, GEDEP user guide form and Sound Decibel Measurement Device were used. Data were evaluated with Chi-square test, Student's t-test and one-way analysis of variance, Mann-Whitney U test and Wilcoxon test. For repeated measurements, dependent groups t test and Wilcoxon signed-rank test were used.
- Being tested
- supported with the developmental support program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supported with the developmental support programBehavioural
Babies were developmentally supported with the developmental support program
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The sample consisted of n=57 premature infants, n=27 in the study group and n=30 in the control group. Data were collected in two stages. In the first stage, mothers sang lullabies to the infants in the study group three times a week and touched them tenderly. In the second stage, developmental support program (GEDEP) was applied to the same infants for three months starting from the 40th week of gestation. The infants in the control group were given routine care. In data collection, Mother and Newborn Descriptive Information Form, Premature Infant Comfort Scale (PICS), Developmental Support Program Evaluation Form, GEDEP user guide form and Sound Decibel Measurement Device were used. Receives: Behavioral: supported with the developmental support program |
| control group | Experimental | The data of the control group were collected in two stages. No intervention was made to the control group by the researcher.
First stage application steps:
* Before starting the application, the Mother and Newborn Information Form (Annex 1) was filled out by the researcher.
* The babies in the control group were cared for and their daily care (hygienic care (oral care, eye care, body care, diaper cleaning, etc.), feeding, taking vital signs, other follow-ups) were carried out by the nurse.
Approximately 10-15 minutes and 20-25 minutes after the care was completed, the baby's responses were evaluated by the researcher with the premature comfort scale.
Second stage: When the babies in the control group reached their first corrected month, developmental evaluations were made by the researcher using the GEDEP evaluation form every four weeks for a total of three months. Receives: Behavioral: supported with the developmental support program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Comfort Scale (PICS),
PICS is a tool that multidimensionally evaluates the behavioral and psychological comfort and pain level of babies. In PBCS, Awakeness, Calmness/Agitation, Respiratory Status (only for those with mechanical ventilation support) or Crying (only for children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate are used to evaluate the baby's comfort level. Seven parameters are used. The scale is a 5-point Likert type scale where each parameter can be scored between 1 (bad) and 5 (good). According to PICS, the baby's comfort is evaluated based on the total score. The highest comfort score of 35 represents the lowest comfort score of 7. The total score determined as the cut-off value of the scale is 17. Babies with a total score of 17 or higher are considered cutoff for comfort level and indicate a need for pain-reducing interventions
Measured: on completion of the study ana average of 1 months
GEDEP (Developmental Support Program) Evaluation Form
It aims to provide a rough assessment of children's cognitive, language/communication, motor, social-emotional and self-care skills in the 0-36 month period. This form contains introductory information such as the child's name, surname, date of birth, age, diagnosis, and parents' names. At the same time, skills in developmental areas included in GEDEP are also included in the form. Skills marked as "cannot do" and/or "partially able" on the form indicate the skills that the child needs to be worked on using GEDEP.
Measured: on completion of the study ana average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start28 Nov 2021
- Primary completion18 Jul 2022
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled experimental study
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, funda güler, Aydin Adnan Menderes University
- Investigators
- hüsniye çalışır, Prof, Study director, study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191757
- Sponsor's protocol ID
- AydınAdnanMenderesUniversıty
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guler F, Calisir H. The Effect of Maternal Lullaby Singing, Affectionate Touch, and a Developmental Support Program on Comfort and Development in Premature Infants: A Randomized Controlled Trial. Nurs Open. 2026 Sep;13(9):e70788. doi: 10.1002/nop2.70788.
PubMed 42677350
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Early Intervention Program Applied To Premature Infants In The Neonatal Intensive Care Unit On Comfort And Development
- ClinicalTrials.gov ID
- NCT06191757
- Acronym / sponsor ID
- AydınAdnanMenderesUniversıty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 5 Jan 2024 (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.
Purpose: This study was conducted to evaluate the effect of singing a lullaby with compassionate touch on early comfort and later on development of developmental support program in premature infants in the neonatal intensive care unit.
H01: Singing a lullaby along with touching in the early stages of premature babies in the neonatal intensive care unit has no effect on the comfort score of the babies.
H02: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the social emotional skills of premature babies.
H03: Singing lullabies with touch to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the language skills of premature babies.
H04: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the cognitive skills of premature babies.
H05: Singing a lullaby along with touching to premature babies in the neonatal intensive care unit in the early period and then applying a developmental support program has no effect on the motor skills of premature babies.
Detailed description
Materials and Methods: This study is a randomized controlled experimental study. The research was carried out in Aydın Adnan Menderes University Application and Research Hospital Neonatal Intensive Care Unit between 28 November 2021 and 18 July 2022. Premature infants at 330/7 -366/7 weeks of gestation who were hospitalized in the neonatal intensive care unit were included in the sampling. The sample consisted of n=57 premature infants, n=27 in the study group and n=30 in the control group. Data were collected in two stages. In the first stage, mothers sang lullabies to the infants in the study group three times a week and touched them tenderly. In the second stage, developmental support program (GEDEP) was applied to the same infants for three months starting from the 40th week of gestation. The infants in the control group were given routine care. In data collection, Mother and Newborn Descriptive Information Form, Premature Infant Comfort Scale (PICS), Developmental Support Program Evaluation Form, GEDEP user guide form and Sound Decibel Measurement Device were used. Data were evaluated with Chi-square test, Student's t-test and one-way analysis of variance, Mann-Whitney U test and Wilcoxon test. For repeated measurements, dependent groups t test and Wilcoxon signed-rank test were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: supported with the developmental support programThe sample consisted of n=57 premature infants, n=27 in the study group and n=30 in the control group. Data were collected in two stages. In the first stage, mothers sang lullabies to the infants in the study group three times a week and touched them tenderly. In the second stage, developmental support program (GEDEP) was applied to the same infants for three months starting from the 40th week of gestation. The infants in the control group were given routine care. In data collection, Mother and Newborn Descriptive Information Form, Premature Infant Comfort Scale (PICS), Developmental Support Program Evaluation Form, GEDEP user guide form and Sound Decibel Measurement Device were used. |
| control group | Experimental | Behavioral: supported with the developmental support programThe data of the control group were collected in two stages. No intervention was made to the control group by the researcher. First stage application steps: * Before starting the application, the Mother and Newborn Information Form (Annex 1) was filled out by the researcher. * The babies in the control group were cared for and their daily care (hygienic care (oral care, eye care, body care, diaper cleaning, etc.), feeding, taking vital signs, other follow-ups) were carried out by the nurse. Approximately 10-15 minutes and 20-25 minutes after the care was completed, the baby's responses were evaluated by the researcher with the premature comfort scale. Second stage: When the babies in the control group reached their first corrected month, developmental evaluations were made by the researcher using the GEDEP evaluation form every four weeks for a total of three months. |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| supported with the developmental support programBabies were developmentally supported with the developmental support program | Behavioural | control group, experimental group |
Primary outcome
Premature Infant Comfort Scale (PICS),
Time frame: on completion of the study ana average of 1 months
PICS is a tool that multidimensionally evaluates the behavioral and psychological comfort and pain level of babies. In PBCS, Awakeness, Calmness/Agitation, Respiratory Status (only for those with mechanical ventilation support) or Crying (only for children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate are used to evaluate the baby's comfort level. Seven parameters are used. The scale is a 5-point Likert type scale where each parameter can be scored between 1 (bad) and 5 (good). According to PICS, the baby's comfort is evaluated based on the total score. The highest comfort score of 35 represents the lowest comfort score of 7. The total score determined as the cut-off value of the scale is 17. Babies with a total score of 17 or higher are considered cutoff for comfort level and indicate a need for pain-reducing interventions
GEDEP (Developmental Support Program) Evaluation Form
Time frame: on completion of the study ana average of 3 months
It aims to provide a rough assessment of children's cognitive, language/communication, motor, social-emotional and self-care skills in the 0-36 month period. This form contains introductory information such as the child's name, surname, date of birth, age, diagnosis, and parents' names. At the same time, skills in developmental areas included in GEDEP are also included in the form. Skills marked as "cannot do" and/or "partially able" on the form indicate the skills that the child needs to be worked on using GEDEP.
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 18 Jan 2024.
- Derived from this study: PubMed 42677350Guler F, Calisir H. The Effect of Maternal Lullaby Singing, Affectionate Touch, and a Developmental Support Program on Comfort and Development in Premature Infants: A Randomized Controlled Trial. Nurs Open. 2026 Sep;13(9):e70788. doi: 10.1002/nop2.70788.
- Individual participant dataSharing planned: No
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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.
hüsniye çalışır, Prof study director
study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supported with the developmental support program in people with Infant Development and Patient Comfort, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Premature Infant Comfort Scale (PICS), (time frame: on completion of the study ana average of 1 months). The study lists 2 primary outcomes in all. 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 NCT06191757, which also lists 1 linked publication.
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 18 Jan 2024; AzTrials last refreshed its copy on 3 Nov 2026.