Nurse's RoleNCT05697653
Effect of Skin to Skin Contact on Sucking Efficiency of Newborns and Breastfeeding Self Efficacy of Mothers in Cesarean Deliveries
A study testing Skin-to-Skin contact. in people with Nurse's Role and Breastfeeding, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Due to the separation of the mother and the baby after the cesarean section, initiation of breastfeeding by the mother of the newborn in the first hour of life is delayed. The rate of cesarean section in Turkey has increased to 52%, according to the 2019 data of the Center for Disease Control and Prevention, the rate… Read more about this study
- Who is it for?
- Ages 1 hour to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Breastfeeding
- What is being tested?
- Skin-to-Skin contact.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2019to 5 May 2021
- 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 hour to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mothers;
- Planning of cesarean section with spinal anesthesia
- Being between the ages of 18- 45
- Having a singleton pregnancy
- Gestational week is between 37-40 weeks
- Absence of any known health problems (diabetes, gestational diabetes, hypertension, preeclampsia, renal failure, cardiac problems, psychiatric disorders, etc.)
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- Agreeing to participate in the study
- Before the skin-to-skin contact procedure, their general condition and vital signs should be checked to be stable
- Being a resident of Kütahya
- Newborns (0-28 days);
- Gestational age between 37-40 weeks
- Birth weight between 2500-4500 g
- 1.-5. minute Apgar Score ≥ 7
- Absence of any health problems, anomalies or congenital diseases
- Absence of obstacles to sucking such as frenulum (tongue-tie) or palate problem
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Due to the separation of the mother and the baby after the cesarean section, initiation of breastfeeding by the mother of the newborn in the first hour of life is delayed. The rate of cesarean section in Turkey has increased to 52%, according to the 2019 data of the Center for Disease Control and Prevention, the rate of cesarean section has increased to 31.7% in the world and up to 65% in the USA. It has been reported in the literature that cesarean deliveries are performed with general, spinal and epidural anesthesia types, and the Apgar scores of newborns after cesarean section performed with spinal and epidural anesthesia are high. In this context, the nurse has a key role in initiating and maintaining breastfeeding after early SSC between the mother and the newborn within the first hour following the cesarean section performed with spinal anesthesia. In the literature, there are studies reporting that skin-to-skin contact applied after normal delivery increases the sucking success of newborns, the successful breastfeeding rate, and the rate of exclusive breastfeeding. There are studies examining the effect of early skin-to-skin contact applied after cesarean section on the suckling success of the newborn and only breastfeeding. Breastfeeding self-efficacy refers to a woman's confidence in her ability to breastfeed her baby. It is reported in the literature that skin-to-skin contact and only breastfeeding education have an effect on breastfeeding self-efficacy.
Read the detailed description
Type of the research: The research was conducted in a randomized controlled experimental type. Mothers and newborns who met the inclusion criteria were randomly selected by tossing a coin and assigned to the intervention or control groups. The data were collected by the researcher by face-to-face interview method.
Independent variable: Skin-to-skin contact. Dependent variables: Sucking efficacy of newborns and breastfeeding self-efficacy of mothers.
Research Hypotheses; H1: Skin-to-skin contact applied after cesarean deliveries performed with spinal anesthesia has an effect on the sucking efficiency of newborns.
H2: Skin-to-skin contact applied after cesarean section with spinal anesthesia has an effect on breastfeeding self-efficacy of mothers
It was performed with a total of 72 women and newborns (37 interventions, 35 control groups) who had a cesarean section with spinal anesthesia in a Training and Research Hospital Gynecology Service in the West of Turkey.
Data were collected using the "Newborn and Parent Information Form", "Breastfeeding Self-Efficacy Short Form Scale" and "LATCH Scale".
- Conditions
- Nurse's Role, Breastfeeding
- Being tested
- Skin-to-Skin contact.
- Keywords
- skin-to-skin contact, cesarean, newborn, breastfeeding self-efficacy
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-Skin contact.Behavioural
Skin to skin contact: It is the laying of the newborn in the prone position on the mother's bare chest with only a diaper on.
| Study group | Role | What they receive |
|---|---|---|
| intervention group (skin-to-skin contact group) | Experimental | skin-to-skin contact: It is the laying of the newborn in the prone position on the mother's bare chest area with only a diaper on. Receives: Behavioral: Skin-to-Skin contact. |
| control group | No intervention | The routine applications of the hospital were applied to the pregnant women in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of skin-to-skin contact on breastfeeding self efficacy of mothers
"Breastfeeding Self-Efficacy Scale Short Form" was used to determine mothers' breastfeeding self-efficacy.
A high score from the scale indicates that the mother's breastfeeding self-efficacy is high.
Measured: through study completion, an average of 1 year
The effect of skin-to-skin contact on breastfeeding success of mothers and sucking success of newborns.
"LATCH Breastfeeding Diagnostic Scale" was used to determine the effect of skin-to-skin contact on breastfeeding success of mothers and breastfeeding success of newborns. A high score from the scale shows that mothers have good breastfeeding success and newborns have good sucking success.
The name of the "LATCH Breastfeeding Diagnostic Scale" consists of the English initials of the 5 assessment criteria; [L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)].
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start18 Nov 2019
- Primary completion13 Mar 2020
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention group and control group, randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697653
- Sponsor's protocol ID
- Nursing123
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 4 Apr 2023
- 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skin to Skin Contact on Sucking Efficiency of Newborns and Breastfeeding Self Efficacy of Mothers in Cesarean Deliveries
- ClinicalTrials.gov ID
- NCT05697653
- Acronym / sponsor ID
- Nursing123
- Conditions
- Nurse's Role, Breastfeeding
- Keywords
- skin-to-skin contact, cesarean, newborn, breastfeeding self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 26 Jan 2023 (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.
Due to the separation of the mother and the baby after the cesarean section, initiation of breastfeeding by the mother of the newborn in the first hour of life is delayed. The rate of cesarean section in Turkey has increased to 52%, according to the 2019 data of the Center for Disease Control and Prevention, the rate of cesarean section has increased to 31.7% in the world and up to 65% in the USA. It has been reported in the literature that cesarean deliveries are performed with general, spinal and epidural anesthesia types, and the Apgar scores of newborns after cesarean section performed with spinal and epidural anesthesia are high. In this context, the nurse has a key role in initiating and maintaining breastfeeding after early SSC between the mother and the newborn within the first hour following the cesarean section performed with spinal anesthesia. In the literature, there are studies reporting that skin-to-skin contact applied after normal delivery increases the sucking success of newborns, the successful breastfeeding rate, and the rate of exclusive breastfeeding. There are studies examining the effect of early skin-to-skin contact applied after cesarean section on the suckling success of the newborn and only breastfeeding. Breastfeeding self-efficacy refers to a woman's confidence in her ability to breastfeed her baby. It is reported in the literature that skin-to-skin contact and only breastfeeding education have an effect on breastfeeding self-efficacy.
Detailed description
Type of the research: The research was conducted in a randomized controlled experimental type. Mothers and newborns who met the inclusion criteria were randomly selected by tossing a coin and assigned to the intervention or control groups. The data were collected by the researcher by face-to-face interview method.
Independent variable: Skin-to-skin contact. Dependent variables: Sucking efficacy of newborns and breastfeeding self-efficacy of mothers.
Research Hypotheses; H1: Skin-to-skin contact applied after cesarean deliveries performed with spinal anesthesia has an effect on the sucking efficiency of newborns.
H2: Skin-to-skin contact applied after cesarean section with spinal anesthesia has an effect on breastfeeding self-efficacy of mothers
It was performed with a total of 72 women and newborns (37 interventions, 35 control groups) who had a cesarean section with spinal anesthesia in a Training and Research Hospital Gynecology Service in the West of Turkey.
Data were collected using the "Newborn and Parent Information Form", "Breastfeeding Self-Efficacy Short Form Scale" and "LATCH Scale".
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention group and control group, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| intervention group (skin-to-skin contact group) | Experimental | Behavioral: Skin-to-Skin contact.skin-to-skin contact: It is the laying of the newborn in the prone position on the mother's bare chest area with only a diaper on. |
| control group | No intervention | –The routine applications of the hospital were applied to the pregnant women in the control group. |
Who may qualify
- Ages
- 1 hour to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Mothers;
- Planning of cesarean section with spinal anesthesia
- Being between the ages of 18- 45
- Having a singleton pregnancy
- Gestational week is between 37-40 weeks
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 |
|---|---|---|
| Skin-to-Skin contact.Skin to skin contact: It is the laying of the newborn in the prone position on the mother's bare chest with only a diaper on. | Behavioural | intervention group (skin-to-skin contact group) |
Primary outcome
The effect of skin-to-skin contact on breastfeeding self efficacy of mothers
Time frame: through study completion, an average of 1 year
"Breastfeeding Self-Efficacy Scale Short Form" was used to determine mothers' breastfeeding self-efficacy. A high score from the scale indicates that the mother's breastfeeding self-efficacy is high.
The effect of skin-to-skin contact on breastfeeding success of mothers and sucking success of newborns.
Time frame: through study completion, an average of 1 year
"LATCH Breastfeeding Diagnostic Scale" was used to determine the effect of skin-to-skin contact on breastfeeding success of mothers and breastfeeding success of newborns. A high score from the scale shows that mothers have good breastfeeding success and newborns have good sucking success. The name of the "LATCH Breastfeeding Diagnostic Scale" consists of the English initials of the 5 assessment criteria; [L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)].
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 4 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin-to-Skin contact. in people with Nurse's Role and Breastfeeding, run by Kutahya Health Sciences 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 15 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 4 Apr 2023. 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?
The effect of skin-to-skin contact on breastfeeding self efficacy of mothers (time frame: through study completion, an average of 1 year). 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?
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 4 Apr 2023.