PretermNCT06204146
The Effect of Massage on Growth And Stress And Stress ,Department of Nursing,
A study testing massage in people with Preterm, run by EMİNE SARIKAMIŞ KALE at 1 site in Turkey (Türkiye).
Trial summary
The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress. While the population of the research is preterm infants at the neonatal intensive care unit of a Medicalpark Batman Hospital between January 2018 and February 2019, the sample is 60 preterm… Read more about this study
- Who is it for?
- Ages 27 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm
- What is being tested?
- massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2017to 10 Jul 2019
- 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 27 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age at birth below 36 weeks + 6 days, Body weight over 1000 g, Do not have any diseases or congenital disorders, Babies who are allowed to be massaged by the NICU's neonatologist was determined as .
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Massage Applied to Preterm Infants On Growth and Stress
The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress. While the population of the research is preterm infants at the neonatal intensive care unit of a Medicalpark Batman Hospital between January 2018 and February 2019, the sample is 60 preterm infants suitable for inclusion criteria. Research data was collected using Preterm Infant Information Form, Preterm Follow-up Form and Newborn Stress Scale. While massage was applied to the infants in the experimental group three times daily for 10 days, the control group received the usual care. Weight, length and head circumference of infants in both experimental and control group were measured by the researcher on 1., 5. and 10. days. In order to evaluate stess level of the massage applied infants, camera records of the infants were taken 15 minutes before and after the massage on 1., 5. and 10. days. Camera records of the infants in the control group were also taken at the same time with those in the experimental group. Camera records were watched and stress level of the infants were evaluated by two observers blind to the research. The data analyses were carried out using In-class Correlation, Frequency, Levene, Two-Way ANOVA for Mixed Measured, Repeated ANOVA tests
Read the detailed description
The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress
- Conditions
- Preterm
- Being tested
- massage
- Keywords
- preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageBehavioural
stressn level and preterm growth
| Study group | Role | What they receive |
|---|---|---|
| massage | Experimental | massage was applied to the infants in the experimental group three times daily for 10 days, Receives: Behavioral: massage |
| control | No intervention | the control group received the usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
physiological parameter is analyzed, it is observed first day and ten day the baby weight
Measured: 10 days
length
physiological is analyzed, it is observed first day and ten day the baby length
Measured: 10 days
head circumference
physiological parameter is analyzed, it is observed first day and ten day the baby head circumference
Measured: 10 days
newborn stres scale
it is an assessment tool developed to evaluate the stress level of newborn. 0-2 point each item min max 16point each subscale
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start24 May 2017
- Primary completion7 Jun 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMİNE SARIKAMIŞ KALE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, EMİNE SARIKAMIŞ KALE, Hasan Kalyoncu University
- Investigators
- emine sarıkamış kale, MSc, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204146
- Sponsor's protocol ID
- 2017/015
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage Applied to Preterm Infants On Growth and Stress
- ClinicalTrials.gov ID
- NCT06204146
- Acronym / sponsor ID
- 2017/015
- Conditions
- Preterm
- Keywords
- preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EMİNE SARIKAMIŞ KALEUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 12 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.
The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress. While the population of the research is preterm infants at the neonatal intensive care unit of a Medicalpark Batman Hospital between January 2018 and February 2019, the sample is 60 preterm infants suitable for inclusion criteria. Research data was collected using Preterm Infant Information Form, Preterm Follow-up Form and Newborn Stress Scale. While massage was applied to the infants in the experimental group three times daily for 10 days, the control group received the usual care. Weight, length and head circumference of infants in both experimental and control group were measured by the researcher on 1., 5. and 10. days. In order to evaluate stess level of the massage applied infants, camera records of the infants were taken 15 minutes before and after the massage on 1., 5. and 10. days. Camera records of the infants in the control group were also taken at the same time with those in the experimental group. Camera records were watched and stress level of the infants were evaluated by two observers blind to the research. The data analyses were carried out using In-class Correlation, Frequency, Levene, Two-Way ANOVA for Mixed Measured, Repeated ANOVA tests
Detailed description
The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| massage | Experimental | Behavioral: massagemassage was applied to the infants in the experimental group three times daily for 10 days, |
| control | No intervention | –the control group received the usual care |
Who may qualify
- Ages
- 27 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age at birth below 36 weeks + 6 days, Body weight over 1000 g, Do not have any diseases or congenital disorders, Babies who are allowed to be massaged by the NICU's neonatologist was determined as .
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| massagestressn level and preterm growth | Behavioural | massage |
Primary outcome
Weight
Time frame: 10 days
physiological parameter is analyzed, it is observed first day and ten day the baby weight
length
Time frame: 10 days
physiological is analyzed, it is observed first day and ten day the baby length
head circumference
Time frame: 10 days
physiological parameter is analyzed, it is observed first day and ten day the baby head circumference
newborn stres scale
Time frame: 10 days
it is an assessment tool developed to evaluate the stress level of newborn. 0-2 point each item min max 16point each subscale
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 10 Dec 2025.
Related trials for Preterm
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.
emine sarıkamış kale, MSc principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage in people with Preterm, run by EMİNE SARIKAMIŞ KALE 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?
The sponsor lists 1 inclusion and 1 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 10 Dec 2025. 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?
Weight (time frame: 10 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.