Kangaroo CareNCT06320587
The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs
A study testing Kangaroo care practice by both mother and father and Kangaroo care practice only mother in people with Kangaroo Care and Fathers, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby. Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Kangaroo Care, Fathers, Mother-Infant Interaction
- What is being tested?
- Kangaroo care practice by both mother and father and Kangaroo care practice only mother
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 30 May 2024
- 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 28 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents who volunteered to participate in the research
- Parents who are Turkish citizens and speak Turkish
- Preterm baby born between 28-37 weeks staying in the neonatal intensive care unit
- The mother and father do not have any obstacles in taking care of the kangaroo.
- Mothers and fathers who can come to the hospital regularly on the specified days will be included in the study.
Who cannot join
- Not volunteering to participate in the research
- Parent's inability to speak Turkish
- Presence of a life-threatening major malformation or serious perinatal complication in the premature baby
- Babies with umbilical catheters and central venous catheters will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Meryem Büşra Borazan contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, 06170
Gönül Kurt, Assoc.prof., 90(312)304 ext. 3934, gonul.kurt@sbu.edu.tr
Meryem Büşra Borazan, busrabrzn.bb@gmail.com
About this study
Official title: Determination of the Effect of Kangaroo Care Applied to Premature Newborns by Their Parents on the Newborn's Vital Signs, Parents' Perceived Parenting Self-Efficacy Level and Infant Attachment
This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby.
Read the detailed description
The research is a randomized controlled trial and an experimental research design will be used. The research will be carried out with two groups as experimental (newborns given kangaroo care by both mother and father) and control (newborns given kangaroo care only by the mother) groups.
- Conditions
- Kangaroo Care, Fathers, Mother-Infant Interaction, Premature Infant
- Being tested
- Kangaroo care practice by both mother and father, Kangaroo care practice only mother
- Keywords
- kangaroo care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo care practice by both mother and fatherOther
In this group, kangaroo care will be done by both mother and father. Mothers used the Mother-Infant Attachment Scale and the Perceived Maternal Parenting Self-Efficacy Scale as pretests; Fathers will also complete the Postpartum Father-Infant Attachment Survey and the Perceived Father Parenting Self-Efficacy Form. Mothers and fathers in the application group will be provided with kangaroo care for 45 minutes, 2 days a week for 5 weeks. The baby's vital signs will be monitored 30 minutes before each kangaroo care, at the 15th minute of each kangaroo care, and 30 minutes after the kangaroo care, and will be recorded on the Kangaroo Care Monitoring Form. After kangaroo care was completed at the end of 5 weeks, mothers used the Mother-Baby Attachment Scale and the Perceived Mother Parenting Self-Efficacy Scale as posttests; Postnatal Father-Infant Attachment Questionnaire and Perceived Father Parenting Self-Efficacy Form will be filled out by fathers.
Kangaroo care practice only motherOther
In the control group, only the mother will care for the kangaroo. The application will be similar to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Newborns in this group will be given kangaroo care by both their mother and father. Receives: Other: Kangaroo care practice by both mother and father |
| Control group | Placebo comparator | Newborns in this group will be given kangaroo care by only the mother. Receives: Other: Kangaroo care practice only mother |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-To-Infant Bonding Scale
It will be applied to evaluate the mother's attachment level to her baby. The lowest score that can be obtained from the scale is 0 and the highest score is 24. The higher the score from the scale, the more it indicates a mother-infant attachment problem.
Measured: It is designed to be applied from the first day after birth. It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
Perceived Mother Parenting Self-Efficacy Scale
It will be applied to measure mothers' perceived parenting self-efficacy. The scale consists of 3 sub-dimensions. These; care procedures, the belief in developing positive baby behaviors, the belief in recognizing the baby's behavior, and mother-baby interaction. The lowest score that can be obtained from the scale is 18 and the highest score is 72.As the score obtained increases, the degree of self-efficacy in mothers increases.
Measured: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
Postnatal Paternal-Infant Attachment Questionnaire
It will be applied to measure fathers' attachment levels to their babies. The lowest score that can be obtained from the scale is 18 and the highest score is 90.A high score from the scale indicates high bonding.
Measured: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
Perceived Father Parenting Self-Efficacy Form
It is aimed to determine the change in fathers' perceived parenting self-efficacy levels. The lowest score that can be obtained from the form is 0 and the highest score is 10. As the score increases, the degree of self effiacy in father increases.
Measured: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
Physiological parameters of the premature infant: peak heart rate (BPM)
It shows heart rate per minute of the infant. The normal peak heart rate should be between 100-160 BPM.
Measured: Change from baseline at 5 weeks.
Physiological parameters of the premature infant: oxygen saturation (%)
Oxygen saturation measures the percentage of oxyhemoglobin in the blood. The normal oxygen saturation should be between % 88 - % 100.
Measured: Change from baseline at 5 weeks.
Physiological parameters of the premature infant: body temperature (°C)
It shows body temperature of the infant. The normal body temperature of premature babies should be between 36,5 °C and 37,4 °C.
Measured: Change from baseline at 5 weeks.
Physiological parameters of the premature infant:Respiration rate (RPM)
It shows respiratory rate per minute of the infants. The normal respiratory rate of premature babies should be in the range of 40-60 RPM.
Measured: Change from baseline at 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Feb 2024
- Primary completion30 Mar 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kangaroo CareStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gönül Kurt, Assoc.Prof, Principal investigator, Gülhane Sağlık Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320587
- Sponsor's protocol ID
- AEŞH-EK1-2023-508
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Kangaroo Care Applied to Premature Newborns by Their Parents on the Newborn's Vital Signs, Parents' Perceived Parenting Self-Efficacy Level and Infant Attachment
- ClinicalTrials.gov ID
- NCT06320587
- Acronym / sponsor ID
- AEŞH-EK1-2023-508
- Conditions
- Kangaroo Care, Fathers, Mother-Infant Interaction, Premature Infant
- Keywords
- kangaroo care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 20 Mar 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 determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby.
Detailed description
The research is a randomized controlled trial and an experimental research design will be used. The research will be carried out with two groups as experimental (newborns given kangaroo care by both mother and father) and control (newborns given kangaroo care only by the mother) groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Kangaroo care practice by both mother and fatherNewborns in this group will be given kangaroo care by both their mother and father. |
| Control group | Placebo comparator | Other: Kangaroo care practice only motherNewborns in this group will be given kangaroo care by only the mother. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parents who volunteered to participate in the research
- Parents who are Turkish citizens and speak Turkish
- Preterm baby born between 28-37 weeks staying in the neonatal intensive care unit
- The mother and father do not have any obstacles in taking care of the kangaroo.
- Mothers and fathers who can come to the hospital regularly on the specified days will be included in the study.
Key exclusion criteria (4 listed)
- Not volunteering to participate in the research
- Parent's inability to speak Turkish
- Presence of a life-threatening major malformation or serious perinatal complication in the premature baby
- Babies with umbilical catheters and central venous catheters will not be included in the study.
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 |
|---|---|---|
| Kangaroo care practice by both mother and fatherIn this group, kangaroo care will be done by both mother and father. Mothers used the Mother-Infant Attachment Scale and the Perceived Maternal Parenting Self-Efficacy Scale as pretests; Fathers will also complete the Postpartum Father-Infant Attachment Survey and the Perceived Father Parenting Self-Efficacy Form. Mothers and fathers in the application group will be provided with kangaroo care for 45 minutes, 2 days a week for 5 weeks. The baby's vital signs will be monitored 30 minutes before each kangaroo care, at the 15th minute of each kangaroo care, and 30 minutes after the kangaroo care, and will be recorded on the Kangaroo Care Monitoring Form. After kangaroo care was completed at the end of 5 weeks, mothers used the Mother-Baby Attachment Scale and the Perceived Mother Parenting Self-Efficacy Scale as posttests; Postnatal Father-Infant Attachment Questionnaire and Perceived Father Parenting Self-Efficacy Form will be filled out by fathers. | Other | Experimental group |
| Kangaroo care practice only motherIn the control group, only the mother will care for the kangaroo. The application will be similar to the experimental group. | Other | Control group |
Primary outcome
Mother-To-Infant Bonding Scale
Time frame: It is designed to be applied from the first day after birth. It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
It will be applied to evaluate the mother's attachment level to her baby. The lowest score that can be obtained from the scale is 0 and the highest score is 24. The higher the score from the scale, the more it indicates a mother-infant attachment problem.
Perceived Mother Parenting Self-Efficacy Scale
Time frame: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
It will be applied to measure mothers' perceived parenting self-efficacy. The scale consists of 3 sub-dimensions. These; care procedures, the belief in developing positive baby behaviors, the belief in recognizing the baby's behavior, and mother-baby interaction. The lowest score that can be obtained from the scale is 18 and the highest score is 72.As the score obtained increases, the degree of self-efficacy in mothers increases.
Postnatal Paternal-Infant Attachment Questionnaire
Time frame: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
It will be applied to measure fathers' attachment levels to their babies. The lowest score that can be obtained from the scale is 18 and the highest score is 90.A high score from the scale indicates high bonding.
Perceived Father Parenting Self-Efficacy Form
Time frame: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.
It is aimed to determine the change in fathers' perceived parenting self-efficacy levels. The lowest score that can be obtained from the form is 0 and the highest score is 10. As the score increases, the degree of self effiacy in father increases.
Physiological parameters of the premature infant: peak heart rate (BPM)
Time frame: Change from baseline at 5 weeks.
It shows heart rate per minute of the infant. The normal peak heart rate should be between 100-160 BPM.
Physiological parameters of the premature infant: oxygen saturation (%)
Time frame: Change from baseline at 5 weeks.
Oxygen saturation measures the percentage of oxyhemoglobin in the blood. The normal oxygen saturation should be between % 88 - % 100.
Physiological parameters of the premature infant: body temperature (°C)
Time frame: Change from baseline at 5 weeks.
It shows body temperature of the infant. The normal body temperature of premature babies should be between 36,5 °C and 37,4 °C.
Physiological parameters of the premature infant:Respiration rate (RPM)
Time frame: Change from baseline at 5 weeks.
It shows respiratory rate per minute of the infants. The normal respiratory rate of premature babies should be in the range of 40-60 RPM.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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Low Birth Weight, Kangaroo Mother Care
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The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy
Procedural Pain, Neonatal Hyperbilirubinemia
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The Effect of the Side Kangaroo Position in Newborns Undergoing Noninvasive Mechanical Ventilation
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Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
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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.
Meryem Büşra Borazan contact
Gönül Kurt, Assoc.Prof principal investigator
Gülhane Sağlık Bilimleri 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 Kangaroo care practice by both mother and father and Kangaroo care practice only mother in people with Kangaroo Care and Fathers, run by Saglik Bilimleri Universitesi 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 5 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: status not confirmed, as of the sponsor's last update on 20 Mar 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gönül Kurt, Assoc.Prof (90(312)304 ext. 3934, gonul.kurt@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-To-Infant Bonding Scale (time frame: It is designed to be applied from the first day after birth. It will be filled in before kangaroo care and after 5 weeks of kangaroo care.). The study lists 8 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 20 Mar 2024.