Infant, NewbornHalf swaddlingNCT06750796
The Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality, Depression
A study testing The Half Swaddling Application in people with Infant, Newborn and Maternal Outcome, run by Tanta University at 1 site in Turkey (Türkiye).
Trial summary
In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn, Maternal Outcome
- What is being tested?
- The Half Swaddling Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2023to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old,
- Term birth (single birth over 37 weeks),
- After an uncomplicated pregnancy process, the delivery was completed by normal vaginal or cesarean delivery method,
- Not using cigarettes, alcohol and stimulants,
- BMI<30,
- Not working on night shift,
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- Stable vital signs,
- Those who have not received infertility treatment,
- Do not have a chronic disease (such as hypertension, diabetes mellitus),
- Not experiencing serious depression, anxiety and stress,
- Not having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.),
- No serious maternal complications,
- Mothers who volunteered to participate in the study will be included in the study.
- For baby;
- Birth weight over 2500 g,
- Stable vital signs,
- APGAR score above 7,
- No serious neonatal complications,
- Midwives without congenital malformations will be included in the study.
Who cannot join
- under 18 years old,
- Preterm birth (under 37 weeks and/or multiple births),
- Incomplete delivery by normal vaginal or cesarean delivery method after a complicated pregnancy process,
- Using cigarettes, alcohol and stimulants,
- BMI>30,
- Working night shift,
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- No stable vital signs,
- Having received infertility treatment,
- Having a chronic disease (such as hypertension, diabetes mellitus),
- Experiencing severe depression, anxiety and stress,
- Having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.),
- Serious maternal complication,
- Mothers who do not volunteer to participate in the study will not be included in the study.
- For baby;
- Birth weight of 2500 g and below,
- No stable vital signs,
- APGAR score below 7,
- Serious neonatal complication,
- Babies with congenital malformations will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trakya University
Edirne, None Selected, 22030
About this study
Official title: The Effect of Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality and Postpartum Depression in Term Infants
In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression.
Read the detailed description
In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression. half swaddling; Half swaddling applied to a newborn baby makes the baby feel completely safe as if they are still in the womb. After laying the soft fabric or baby blanket, it will be placed in the supine position. It is swaddling in a way that does not restrict the movement of the baby's arms and legs too much. n=128 (64=control, 64=half swaddling group) mothers and babies who volunteered to participate in the study will be randomized into two groups as case and control. In the half stock group; From the 1st to the 3rd month, half swaddling will be done 15 minutes before each sleep during the day. 0 (first meeting), 1, 2 and 3 months will be interviewed by phone for follow-up purposes.
- Conditions
- Infant, Newborn, Maternal Outcome
- Being tested
- The Half Swaddling Application
- Keywords
- Infant, half swaddling, maternal sleep quality, postpartum depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Half Swaddling ApplicationBehavioural
Half swaddling application in term babies
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The group that will not be treated with half swaddling Receives: Behavioral: The Half Swaddling Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months
Measured: Postpartum first 3 months
Pittsburgh Sleep Quality Index
Measured: up to 3 months
Edinburgh Postnatal Depression Scale
Measured: up to 3 months
Short Infant Sleep Routine Questionnaire
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start18 May 2023
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
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, NewbornStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Non-randomised
- Intervention model
- Single group
- Model description
- In this study, n=128 (64=control, 64=half swaddling group) mothers and infants who volunteered to participate in the study will be conducted in two groups as case and control, randomly.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Kahyaoglu Sut, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750796
- Sponsor's protocol ID
- Prospective controlled study
- Acronym
- Half swaddling
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For data privacy
Publications
Sobaihi M, Banjari MA, Alahmadi TS. Implementation of Safe Sleep Practice Recommendations for Infants in Inpatient Wards. Cureus. 2020 Oct 25;12(10):e11155. doi: 10.7759/cureus.11155.
PubMed 33251063
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality and Postpartum Depression in Term Infants
- ClinicalTrials.gov ID
- NCT06750796
- Acronym / sponsor ID
- Half swaddling / Prospective controlled study
- Conditions
- Infant, Newborn, Maternal Outcome
- Keywords
- Infant, half swaddling, maternal sleep quality, postpartum depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 27 Dec 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.
In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression.
Detailed description
In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression. half swaddling; Half swaddling applied to a newborn baby makes the baby feel completely safe as if they are still in the womb. After laying the soft fabric or baby blanket, it will be placed in the supine position. It is swaddling in a way that does not restrict the movement of the baby's arms and legs too much. n=128 (64=control, 64=half swaddling group) mothers and babies who volunteered to participate in the study will be randomized into two groups as case and control. In the half stock group; From the 1st to the 3rd month, half swaddling will be done 15 minutes before each sleep during the day. 0 (first meeting), 1, 2 and 3 months will be interviewed by phone for follow-up purposes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study, n=128 (64=control, 64=half swaddling group) mothers and infants who volunteered to participate in the study will be conducted in two groups as case and control, randomly.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Behavioral: The Half Swaddling ApplicationThe group that will not be treated with half swaddling |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 18-45 years old,
- Term birth (single birth over 37 weeks),
- After an uncomplicated pregnancy process, the delivery was completed by normal vaginal or cesarean delivery method,
- Not using cigarettes, alcohol and stimulants,
- BMI<30,
Key exclusion criteria (19 listed)
- under 18 years old,
- Preterm birth (under 37 weeks and/or multiple births),
- Incomplete delivery by normal vaginal or cesarean delivery method after a complicated pregnancy process,
- Using cigarettes, alcohol and stimulants,
- BMI>30,
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 |
|---|---|---|
| The Half Swaddling ApplicationHalf swaddling application in term babies | Behavioural | Control group |
Primary outcome
Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months
Time frame: Postpartum first 3 months
Pittsburgh Sleep Quality Index
Time frame: up to 3 months
Edinburgh Postnatal Depression Scale
Time frame: up to 3 months
Short Infant Sleep Routine Questionnaire
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 33251063Sobaihi M, Banjari MA, Alahmadi TS. Implementation of Safe Sleep Practice Recommendations for Infants in Inpatient Wards. Cureus. 2020 Oct 25;12(10):e11155. doi: 10.7759/cureus.11155.
- Swaddling: Is it Safe for Your Baby?Link provided by the sponsor.
- Individual participant dataSharing planned: No. For data privacy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Half Swaddling Application in people with Infant, Newborn and Maternal Outcome, run by Tanta 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 19 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 27 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Kahyaoglu Sut, 1. (05337662979 ext. +90, haticesut@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months (time frame: Postpartum first 3 months). 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?
On the ClinicalTrials.gov record for NCT06750796, 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 27 Dec 2024.