NewbornNCT05789836
The Effect of Partıcıpatıon in Care of Mothers
A study testing Nursing care in people with Newborn and Attachment, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the effect of including mothers with newborn babies in surgical intensive care units during the nursing care process on mother's self-confidence and mother-infant attachment. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn, Attachment, Self Confidence
- What is being tested?
- Nursing care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Aug 2023
- 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
- Inpatient treatment of the baby in the surgical neonatal intensive care unit without the mother's presence since birth
- The mother stays with the baby for at least 4 days in the post-operative period
- The mother does not have any communication and language problems
- The mother's willingness to participate in the research
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Eyalet/Yerleşke, 60200
About this study
Official title: The Effect Of Participation in Care Of Mothers With Newborn Baby in Surgical Intensive Care On Mother's Self-Confidence And Mother-Infant Attachment
The aim of the study is to examine the effect of including mothers with newborn babies in surgical intensive care units during the nursing care process on mother's self-confidence and mother-infant attachment.
Read the detailed description
Population and Sample of the Research
The population of the study consists of mothers who were hospitalized with their babies in the surgical intensive care unit in a children's hospital in Ankara (Turkiye). It is planned that the mothers who were hospitalized with their babies in the surgical intensive care unit for a period of 6 months between the dates of the study and who met the criteria for inclusion in the study constitute the sample of the study.
- Conditions
- Newborn, Attachment, Self Confidence, Nursing Caries
- Being tested
- Nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing careOther
Involving the mother in nursing care
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | This research was planned as a single group pretest-posttest quasi-experimental. Receives: Other: Nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taylor Mother-Infant Attachment Scale
The answers consisting of four options are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 24.
Measured: 6 month
Pharis Self-Confidence Scale
The Pharis Self-Confidence Scale, a 13-item, five-point measurement tool, measures a parent's feelings of self-confidence about daily baby care. Each infant care item is rated from 1 (not at all) to 5 (completely). High total score results indicate high self-confidence in babysitting.
Measured: 6 month
Care Participation Assessment Scale
Care practices of mothers are evaluated as Yes-No and scored as 1-0. Although the maximum score that can be obtained from the scale is 19, an increase in the score means that participation in care has dropped.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Apr 2022
- Primary completion30 Sep 2022
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NewbornStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This research was planned as a single group pretest-posttest quasi-experimental.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukaddes Demir Acar, Tokat Gaziosmanpasa University
- Investigators
- Mukaddes Demir Acar, Study chair, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789836
- Sponsor's protocol ID
- TOGUMDEMIRACAR
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakulak HA, Alparslan, Ö. Anne-bebek Bağlanma Ölçeğinin Türk Toplumuna Uyarlanması: Aydın Örneği. Çağdaş Tıp Dergisi. 2016; 6(3), 188-199.
Karaçam Z, Çakmak E, Yenidoğan Yoğun Bakım Ünitesinde Bebeği Yatan Anneler İçin Bakıma Katılımı Değerlendirme Ölçeği: Ölçek Geliştirme, Geçerlilik ve Güvenilirliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi. 2018; 21(2), 69-78.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Participation in Care Of Mothers With Newborn Baby in Surgical Intensive Care On Mother's Self-Confidence And Mother-Infant Attachment
- ClinicalTrials.gov ID
- NCT05789836
- Acronym / sponsor ID
- TOGUMDEMIRACAR
- Conditions
- Newborn, Attachment, Self Confidence, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 29 Mar 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.
The aim of the study is to examine the effect of including mothers with newborn babies in surgical intensive care units during the nursing care process on mother's self-confidence and mother-infant attachment.
Detailed description
Population and Sample of the Research
The population of the study consists of mothers who were hospitalized with their babies in the surgical intensive care unit in a children's hospital in Ankara (Turkiye). It is planned that the mothers who were hospitalized with their babies in the surgical intensive care unit for a period of 6 months between the dates of the study and who met the criteria for inclusion in the study constitute the sample of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This research was planned as a single group pretest-posttest quasi-experimental.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Nursing careThis research was planned as a single group pretest-posttest quasi-experimental. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatient treatment of the baby in the surgical neonatal intensive care unit without the mother's presence since birth
- The mother stays with the baby for at least 4 days in the post-operative period
- The mother does not have any communication and language problems
- The mother's willingness to participate in the research
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 |
|---|---|---|
| Nursing careInvolving the mother in nursing care | Other | Study Group |
Primary outcome
Taylor Mother-Infant Attachment Scale
Time frame: 6 month
The answers consisting of four options are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 24.
Pharis Self-Confidence Scale
Time frame: 6 month
The Pharis Self-Confidence Scale, a 13-item, five-point measurement tool, measures a parent's feelings of self-confidence about daily baby care. Each infant care item is rated from 1 (not at all) to 5 (completely). High total score results indicate high self-confidence in babysitting.
Care Participation Assessment Scale
Time frame: 6 month
Care practices of mothers are evaluated as Yes-No and scored as 1-0. Although the maximum score that can be obtained from the scale is 19, an increase in the score means that participation in care has dropped.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Results publicationKarakulak HA, Alparslan, Ö. Anne-bebek Bağlanma Ölçeğinin Türk Toplumuna Uyarlanması: Aydın Örneği. Çağdaş Tıp Dergisi. 2016; 6(3), 188-199.
- Results publicationKaraçam Z, Çakmak E, Yenidoğan Yoğun Bakım Ünitesinde Bebeği Yatan Anneler İçin Bakıma Katılımı Değerlendirme Ölçeği: Ölçek Geliştirme, Geçerlilik ve Güvenilirliği. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi. 2018; 21(2), 69-78.
- 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.
Mukaddes Demir Acar study chair
Tokat Gaziosmanpasa 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 Nursing care in people with Newborn and Attachment, run by Tokat Gaziosmanpasa 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 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: status not confirmed, as of the sponsor's last update on 31 Mar 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?
Results are not available in the source record.
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?
Taylor Mother-Infant Attachment Scale (time frame: 6 month). 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 NCT05789836, which also lists 2 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 31 Mar 2023.