Infant, Premature, DiseasesNCT04741672
Home Support for Mothers Whose Premature Infants
A study testing Providing guidance after discharge routine procedure and calling one week after discharge. and Discharge routine procedure. in people with Infant, Premature, Diseases and Mothers, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Premature births are a challenging process for parents in many ways. Especially after the treatment and care in the hospital, they are concerned about whether they will be able to provide adequate care for their baby at home. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Diseases, Mothers
- What is being tested?
- Providing guidance after discharge routine procedure and calling one week after discharge. and Discharge routine procedure.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2021to 1 Aug 2022
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The infant was born prematurely (37 weeks of gestation + 6 days earlier),
- Does not have advanced congenital anomalies in the baby,
- Who will carry out the primary care of the infant at home,
- Reading and writing,
- Can speak and understand Turkish,
- Mothers who agreed to participate in the study
Who cannot join
- Incomplete filling of the forms
- Mothers who previously had training in newborn care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Support for Mothers Whose Premature Infants Discharged From the Neonatal Intensive Care Unit: A Randomized Controlled Study
Premature births are a challenging process for parents in many ways. Especially after the treatment and care in the hospital, they are concerned about whether they will be able to provide adequate care for their baby at home. The aim of this study is to examine the effect of the guide and telephone support given to mothers whose premature infants were discharged from the neonatal intensive care unit on the perceived maternal self-efficacy and state anxiety levels.
Read the detailed description
The study was planned as a randomized controlled trial with a single blind, pretest-posttest design. This study will be conducted between February 2021 and March 2022 with premature infants mothers. The sample of the study will be mothers (n = 102) of premature infants discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit. 51 mothers participating in the study will be given a premature infant home care guide after the discharge routine procedures are completed. In addition, mothers will be given an appointment for a phone call a week later. No intervention will be applied to the other 51 mothers after their discharge routine. Data will be collected by Mother-Infant Descriptive Information Form, Perceived Maternity Self-Efficacy Scale (PMSES), State Anxiety Inventory (SAI). Data will be collected with forms and scales immediately after discharge (pre-test) and in the 4th week after discharge (post-test). Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University. It is predicted that the new information obtained from the research data will guide the education of premature infant mothers and new researches.
- Conditions
- Infant, Premature, Diseases, Mothers
- Being tested
- Providing guidance after discharge routine procedure and calling one week after discharge., Discharge routine procedure.
- Keywords
- Infant, Mothers
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing guidance after discharge routine procedure and calling one week after discharge.Behavioural
Guidance will be given to mothers after routine discharge. After one week, she will be called by phone and her questions about infant care will be answered.
Discharge routine procedure.Behavioural
Discharge routine procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Providing guidance and calling after discharge routine procedure. Receives: Behavioral: Providing guidance after discharge routine procedure and calling one week after discharge.; Behavioral: Discharge routine procedure. |
| Control group | Experimental | Discharge routine procedure. Receives: Behavioral: Discharge routine procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Maternity Self-Efficacy Scale
The scale, valid and reliable in our country by Kadiroglu (2018), has 19 items and three sub-dimensions.A minimum of 19 and a maximum of 76 points can be obtained on the scale.
Measured: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)
State Anxiety Inventory
The scale was developed to measure what has been felt for the last 7 days. It is a Likert-type scale consisting of 20 items and graded between 1 and 4. The scores obtained from the scale range from 20 to 80.
Measured: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start22 Feb 2021
- Primary completion1 Mar 2022
- Study completion1 Aug 2022
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, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was pretest-posttest design, randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Akcan, Akdeniz University
- Investigators
- Arzu Akcan, PhD, Study director, Akdeniz UniverstiyEzgi Boz, Postgraduate, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741672
- Sponsor's protocol ID
- 19113
- Status last verified
- Jul 2023
- First submitted
- 25 Jan 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SY, Chau JPC, Choi KC, Lo SHS. Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial. BMC Pediatr. 2019 Nov 4;19(1):402. doi: 10.1186/s12887-019-1794-y.
PubMed 31684903
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Support for Mothers Whose Premature Infants Discharged From the Neonatal Intensive Care Unit: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04741672
- Acronym / sponsor ID
- 19113
- Conditions
- Infant, Premature, Diseases, Mothers
- Keywords
- Infant, Mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 5 Feb 2021 (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.
Premature births are a challenging process for parents in many ways. Especially after the treatment and care in the hospital, they are concerned about whether they will be able to provide adequate care for their baby at home. The aim of this study is to examine the effect of the guide and telephone support given to mothers whose premature infants were discharged from the neonatal intensive care unit on the perceived maternal self-efficacy and state anxiety levels.
Detailed description
The study was planned as a randomized controlled trial with a single blind, pretest-posttest design. This study will be conducted between February 2021 and March 2022 with premature infants mothers. The sample of the study will be mothers (n = 102) of premature infants discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit. 51 mothers participating in the study will be given a premature infant home care guide after the discharge routine procedures are completed. In addition, mothers will be given an appointment for a phone call a week later. No intervention will be applied to the other 51 mothers after their discharge routine. Data will be collected by Mother-Infant Descriptive Information Form, Perceived Maternity Self-Efficacy Scale (PMSES), State Anxiety Inventory (SAI). Data will be collected with forms and scales immediately after discharge (pre-test) and in the 4th week after discharge (post-test). Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University. It is predicted that the new information obtained from the research data will guide the education of premature infant mothers and new researches.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This was pretest-posttest design, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Providing guidance after discharge routine procedure and calling one week after discharge., Behavioral: Discharge routine procedure.Providing guidance and calling after discharge routine procedure. |
| Control group | Experimental | Behavioral: Discharge routine procedure.Discharge routine procedure. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The infant was born prematurely (37 weeks of gestation + 6 days earlier),
- Does not have advanced congenital anomalies in the baby,
- Who will carry out the primary care of the infant at home,
- Reading and writing,
- Can speak and understand Turkish,
Key exclusion criteria (2 listed)
- Incomplete filling of the forms
- Mothers who previously had training in newborn care
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 |
|---|---|---|
| Providing guidance after discharge routine procedure and calling one week after discharge.Guidance will be given to mothers after routine discharge. After one week, she will be called by phone and her questions about infant care will be answered. | Behavioural | Intervention group |
| Discharge routine procedure.Discharge routine procedure. | Behavioural | Control group, Intervention group |
Primary outcome
Perceived Maternity Self-Efficacy Scale
Time frame: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)
The scale, valid and reliable in our country by Kadiroglu (2018), has 19 items and three sub-dimensions.A minimum of 19 and a maximum of 76 points can be obtained on the scale.
State Anxiety Inventory
Time frame: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)
The scale was developed to measure what has been felt for the last 7 days. It is a Likert-type scale consisting of 20 items and graded between 1 and 4. The scores obtained from the scale range from 20 to 80.
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 20 Jul 2023.
- Background: PubMed 31684903Lee SY, Chau JPC, Choi KC, Lo SHS. Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial. BMC Pediatr. 2019 Nov 4;19(1):402. doi: 10.1186/s12887-019-1794-y.
- Individual participant dataSharing planned: No
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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.
Arzu Akcan, PhD study director
Akdeniz Universtiy
Ezgi Boz, Postgraduate study chair
Akdeniz 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 Providing guidance after discharge routine procedure and calling one week after discharge. and Discharge routine procedure. in people with Infant, Premature, Diseases and Mothers, run by Akdeniz 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 6 inclusion and 2 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 20 Jul 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?
Perceived Maternity Self-Efficacy Scale (time frame: 0-1 months (Immediately before discharge training and 4 weeks after discharge training completion)). 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?
On the ClinicalTrials.gov record for NCT04741672, 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 20 Jul 2023.