Infant DevelopmentNCT06436404
Hammock Position and Kangaroo Care
A study testing Hammock intervention and Kangaroo care intervention in people with Infant Development and Premature, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to evaluate the effectiveness of two positions that may have an effect on pain, stress, comfort and physiological parameters in premature infants. Read more about this study
- Who is it for?
- Ages 32 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Premature
- What is being tested?
- Hammock intervention and Kangaroo care intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 20 May 2025
- 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 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants having at least 2 days of inpatient treatment from,
- Infants 32-36+6. being born during the gestational week,
- Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),
- Apgar score above 6 at the 5th minute Infants will included.
Who cannot join
- Infants having at least 2 days of inpatient treatment from,
- Infants 32-36+6. being born during the gestational week,
- Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),
- Apgar score above 6 at the 5th minute Infants will included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Niğde Ömer Halisdemir University
Niğde, Center, 51000
About this study
Official title: Effect of Two Different Positions on Pain, Stress, Comfort and Physiological Parameters of the Premature Infants: Randomized Controlled Trial
This study was planned to evaluate the effectiveness of two positions that may have an effect on pain, stress, comfort and physiological parameters in premature infants.
Read the detailed description
Providing adequate therapeutic positioning in preterms can minimize postural abnormalities and asymmetries associated with prematurity and NICU stay, as well as support the development of spontaneous and functional motor abilities of infants. Studies show that positioning directly affects cardiovascular, respiratory and sleep-wake states. When the literature is examined; Although the vital signs, pain levels and comfort levels of babies in the NICU have been examined in many applications, the number of studies comparing the hammock position and Kangaroo care in preterms is very limited. Therefore, this study will try to determine the effect of hammock position and kangaroo care on the pain, stress, comfort and physiological parameters of the infants. It is thought that the study will provide new data to the literature and lead to many researches.
- Conditions
- Infant Development, Premature
- Being tested
- Hammock intervention, Kangaroo care intervention
- Keywords
- Premature, Pain, Stress, Comfort
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hammock interventionOther
It is a hammock made of 100% cotton fabric that prevents heat loss and has an internal apparatus to support the position, which can be adapted to the incubator by the researchers.
Kangaroo care interventionOther
In the clinic, the baby will receive kangaroo care with his mother in a quiet room with reduced lighting.
| Study group | Role | What they receive |
|---|---|---|
| Hammock position group | Experimental | A hammock inside the incubator, developed by researchers to prevent heat loss and support posture, will be used. Receives: Other: Hammock intervention |
| Kangaroo care group | Experimental | Kangaroo care will be applied to these preterm infants. Receives: Other: Kangaroo care intervention |
| Contol group | No intervention | The group will not receive any other intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the descriptive characteristics of babies
1- Infant Introductory Form: The form includes introductory information about the baby (Postnatal day, gestational age, birth weight (g), weight on the day of the intervention, type of birth, gender, postnatal age, physiological weight loss, feeding style, 1st and 5th minute Apgar score, maternal age. It consists of questions containing).
Measured: 1 hour
Hammock position and Kangaroo care increase comfort level in preterm infants
2- The COMFORT-behavior scale (COMFORTneo): It is a Likert-type scale developed to be used in evaluating the sedation and comfort needs, pain and distress of newborns monitored in intensive care. The scale was revised for newborns. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.
Measured: 1 hour
Hammock position and Kangaroo care decrease pain and stress level in preterm infants
3- ALPS-Neo "Newborn Pain and Stress Assessment Scale": The scale was developed in 2014 to evaluate pain and stress in premature and term newborns. Measurement is made through observation. As the score obtained increases, stress and pain increase.
Measured: 1 hour
Secondary outcomes (1)
Hammock position and Kangaroo care support physiological stability in premature infants.
1- Physiological Parameter Tracking Chart The follow-up chart prepared by the researcher is a form in which physiological parameters such as heart rate (min), oxygen saturation (%SpO2), body temperature (°C), respiratory rate (min) are recorded. Measurements will be taken 3 times in total: before, during and after the hammock position and kangaroo care application. A monitor device used in clinical routine will be used to measure physiological parameters.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jan 2025
- Primary completion1 Mar 2025
- Study completion20 May 2025
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 Infant DevelopmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, single-blind parallel design experimental study.In the study, premature infants will be divided into three groups by randomization. Each group will be referred to as A, B or C for convenience. The type of intervention will be determined by drawing lots for A, B and C. For example, A= Hammock Position, B= Kangaroo Care c=Control Group. When applying the hammock position to a group; The other group will receive kangaroo care, while the other group will receive standard care. For randomization, blocks of 3 created for 42 infants and this process done by an independent statistician.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Collaborators
- Selcuk University
- Responsible party
- Sponsor
- Investigators
- Sibel KUCUKOGLU, Ph.D., Study director, Selcuk UniversityHalil DEGIRMENCIOGLU, Md., Principal investigator, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436404
- Sponsor's protocol ID
- He2
- Status last verified
- Dec 2024
- First submitted
- 8 May 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published
Publications
Indyk HE, Woollard DC. Enzymatic determination of free carnitine in milk and infant formulas. J AOAC Int. 1995 Jan-Feb;78(1):69-74.
PubMed 7703730Costa KSF, Fernandes DDS, Paula RAP, Guarda LEDA, Dare MF, Castral TC, Ribeiro LM. Hammock and nesting in preterm infants: randomized controlled trial. Rev Bras Enferm. 2019 Dec;72(suppl 3):96-102. doi: 10.1590/0034-7167-2018-0099. English, Portuguese.
PubMed 31851240Gerull R, Cignacco E, Stoffel L, Sellam G, Nelle M. Physiological parameters after nonpharmacological analgesia in preterm infants: a randomized trial. Acta Paediatr. 2013 Aug;102(8):e368-73. doi: 10.1111/apa.12288. Epub 2013 May 28.
PubMed 23651076Huang CM, Tung WS, Kuo LL, Ying-Ju C. Comparison of pain responses of premature infants to the heelstick between containment and swaddling. J Nurs Res. 2004 Mar;12(1):31-40. doi: 10.1097/01.jnr.0000387486.78685.c5.
PubMed 15136961Schwendener RA, Schott H, Hartmann HR, Supersaxo A, Rubas W, Hengartner H. [Liposomes as carriers of lipophilic cytosine arabinoside and fluorodeoxyuridine derivatives. Their cytostatic effect and possibilities of tumor cell specific therapy]. Onkologie. 1987 Aug;10(4):232-9. doi: 10.1159/000216411. German.
PubMed 2959889
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Positions on Pain, Stress, Comfort and Physiological Parameters of the Premature Infants: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06436404
- Acronym / sponsor ID
- He2
- Conditions
- Infant Development, Premature
- Keywords
- Premature, Pain, Stress, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Collaborators
- Selcuk University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 31 May 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.
This study was planned to evaluate the effectiveness of two positions that may have an effect on pain, stress, comfort and physiological parameters in premature infants.
Detailed description
Providing adequate therapeutic positioning in preterms can minimize postural abnormalities and asymmetries associated with prematurity and NICU stay, as well as support the development of spontaneous and functional motor abilities of infants. Studies show that positioning directly affects cardiovascular, respiratory and sleep-wake states. When the literature is examined; Although the vital signs, pain levels and comfort levels of babies in the NICU have been examined in many applications, the number of studies comparing the hammock position and Kangaroo care in preterms is very limited. Therefore, this study will try to determine the effect of hammock position and kangaroo care on the pain, stress, comfort and physiological parameters of the infants. It is thought that the study will provide new data to the literature and lead to many researches.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled, single-blind parallel design experimental study.In the study, premature infants will be divided into three groups by randomization. Each group will be referred to as A, B or C for convenience. The type of intervention will be determined by drawing lots for A, B and C. For example, A= Hammock Position, B= Kangaroo Care c=Control Group. When applying the hammock position to a group; The other group will receive kangaroo care, while the other group will receive standard care. For randomization, blocks of 3 created for 42 infants and this process done by an independent statistician.
| Arm | Type | Receives |
|---|---|---|
| Hammock position group | Experimental | Other: Hammock interventionA hammock inside the incubator, developed by researchers to prevent heat loss and support posture, will be used. |
| Kangaroo care group | Experimental | Other: Kangaroo care interventionKangaroo care will be applied to these preterm infants. |
| Contol group | No intervention | –The group will not receive any other intervention. |
Who may qualify
- Ages
- 32 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants having at least 2 days of inpatient treatment from,
- Infants 32-36+6. being born during the gestational week,
- Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),
- Apgar score above 6 at the 5th minute Infants will included.
Key exclusion criteria (4 listed)
- Infants having at least 2 days of inpatient treatment from,
- Infants 32-36+6. being born during the gestational week,
- Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),
- Apgar score above 6 at the 5th minute Infants will included.
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 |
|---|---|---|
| Hammock interventionIt is a hammock made of 100% cotton fabric that prevents heat loss and has an internal apparatus to support the position, which can be adapted to the incubator by the researchers. | Other | Hammock position group |
| Kangaroo care interventionIn the clinic, the baby will receive kangaroo care with his mother in a quiet room with reduced lighting. | Other | Kangaroo care group |
Primary outcome
Determining the descriptive characteristics of babies
Time frame: 1 hour
1- Infant Introductory Form: The form includes introductory information about the baby (Postnatal day, gestational age, birth weight (g), weight on the day of the intervention, type of birth, gender, postnatal age, physiological weight loss, feeding style, 1st and 5th minute Apgar score, maternal age. It consists of questions containing).
Hammock position and Kangaroo care increase comfort level in preterm infants
Time frame: 1 hour
2- The COMFORT-behavior scale (COMFORTneo): It is a Likert-type scale developed to be used in evaluating the sedation and comfort needs, pain and distress of newborns monitored in intensive care. The scale was revised for newborns. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.
Hammock position and Kangaroo care decrease pain and stress level in preterm infants
Time frame: 1 hour
3- ALPS-Neo "Newborn Pain and Stress Assessment Scale": The scale was developed in 2014 to evaluate pain and stress in premature and term newborns. Measurement is made through observation. As the score obtained increases, stress and pain increase.
1 secondary outcome
Hammock position and Kangaroo care support physiological stability in premature infants.
Time frame: 1 hour
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 25 May 2025.
- Background: PubMed 7703730Indyk HE, Woollard DC. Enzymatic determination of free carnitine in milk and infant formulas. J AOAC Int. 1995 Jan-Feb;78(1):69-74.
- Background: PubMed 31851240Costa KSF, Fernandes DDS, Paula RAP, Guarda LEDA, Dare MF, Castral TC, Ribeiro LM. Hammock and nesting in preterm infants: randomized controlled trial. Rev Bras Enferm. 2019 Dec;72(suppl 3):96-102. doi: 10.1590/0034-7167-2018-0099. English, Portuguese.
- Background: PubMed 23651076Gerull R, Cignacco E, Stoffel L, Sellam G, Nelle M. Physiological parameters after nonpharmacological analgesia in preterm infants: a randomized trial. Acta Paediatr. 2013 Aug;102(8):e368-73. doi: 10.1111/apa.12288. Epub 2013 May 28.
- Background: PubMed 15136961Huang CM, Tung WS, Kuo LL, Ying-Ju C. Comparison of pain responses of premature infants to the heelstick between containment and swaddling. J Nurs Res. 2004 Mar;12(1):31-40. doi: 10.1097/01.jnr.0000387486.78685.c5.
- Background: PubMed 2959889Schwendener RA, Schott H, Hartmann HR, Supersaxo A, Rubas W, Hengartner H. [Liposomes as carriers of lipophilic cytosine arabinoside and fluorodeoxyuridine derivatives. Their cytostatic effect and possibilities of tumor cell specific therapy]. Onkologie. 1987 Aug;10(4):232-9. doi: 10.1159/000216411. German.
- Individual participant dataSharing planned: No. It will be shared after the article is published
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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.
Sibel KUCUKOGLU, Ph.D. study director
Selcuk University
Halil DEGIRMENCIOGLU, Md. principal investigator
Nigde Omer Halisdemir 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 Hammock intervention and Kangaroo care intervention in people with Infant Development and Premature, run by Nigde Omer Halisdemir 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?
The sponsor lists 4 inclusion and 4 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 25 May 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?
Determining the descriptive characteristics of babies (time frame: 1 hour). The study lists 3 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 NCT06436404, 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 25 May 2025.