Maternal-Fetal RelationsNCT05910346
The Effect of Training and Counseling Based on Mercer Maternal Role Theory on Maternal Attachment and Maternal Function
A study testing education and counseling based on maternal role theory in people with Maternal-Fetal Relations and Maternal Behavior, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Motherhood role gain is the composition of social roles and developmental behaviors and attitudes that continue with the formation of motherhood identity development in the postnatal period that started during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal-Fetal Relations, Maternal Behavior
- What is being tested?
- education and counseling based on maternal role theory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 20 Aug 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least primary school graduate,
- Between the ages of 18-35,
- At the 30nd week of pregnancy and above,
- Having a single and healthy fetus,
- Pregnant women who are open to communication and cooperation
Who cannot join
- Having a risky pregnancy history (pregnancies under 18 and over 35 years of age, EDT, PROM, Preeclampsia, Eclampsia, Epilepsy, GDM)
- Having a treatment pregnancy (mothers who became pregnant with ART),
- Having a chronic disease (DM, HT, Asthma, Epilepsy, Autoimmune diseases, self-report),
- Having a psychiatric illness (based on self-report and clinical diagnosis),
- Foreign nationals,
- Living outside the province of Konya,
- Pregnant women who participated in any childbirth preparation training program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Training and Counseling Based on Mercer's Maternal Role Theory on Maternal Attachment and Maternal Function: A Randomized Controlled Study
Motherhood role gain is the composition of social roles and developmental behaviors and attitudes that continue with the formation of motherhood identity development in the postnatal period that started during pregnancy. In many studies, it is stated that mothers should be prepared to transition to motherhood roles in the prenatal period in order to enable them to develop successful motherhood identity. This study will be carried out to determine the effect of structured birth preparation education on the material attachment status and motherhood function according to the theory of motherhood. The study was planned as a single -blind, post -test parallel group randomized controlled experimental study. The universe of the study will form pregnant women who apply to Necmettin Erbakan University Meram Medical Faculty Hospital Birth and Gynecology Polyclinic and Clinic. When the sample of the study was calculated as 95 %confidence interval, 5 %error and 80 %power, a total of 44 cases, 22 for the experimental group and 22 for the control group were found to be suitable for statistical analyzes. In this study, assuming that the loss rates in the literature will be 20 %loss when reference, 28 to the experimental group and 28 to the control group will be included in the initially 56 pregnant studies. The data will be collected using the 'Personal Information Form, Postpartum Period Features Information Form, Maternal Binding Scale and Barkin Maternity Function Inventory. Pregnant women in the experimental group will start in the 32nd gestational week and will be given structured training and counseling according to the theory of motherhood. Pregnant women in the control group will take standard care. Number, percentage, average and standard deviation analysis will be used for descriptive statistics. Parametric and nonparametric tests will be applied according to the compliance of the data for the normal distribution of the data in the study pattern in independent groups and recurrent tests. The results will be tested at P <0.05 significance level. In order to collect the data, Ethical Permission was obtained by the Decision No. 2022/024 from the Ethics Committee of KTO Karatay University Pharmaceutical and Medical Research. Necmettin Erbakan University Meram Medical Faculty Hospital will be obtained from the institution. Before starting to work, verbal and written permissions will be obtained by reading the voluntary information form to all pregnant women. Maternal attachment inventory and Barkin Motherhood Function Scale Writers were permitted via e-mail.
- Conditions
- Maternal-Fetal Relations, Maternal Behavior
- Being tested
- education and counseling based on maternal role theory
- Keywords
- maternal identity, maternal role, being a mother
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and counseling based on maternal role theoryBehavioural
Pregnant women in the experimental group will be given training and counseling based on the maternal role theory, starting at 32 weeks of gestation (1 week in total, 2 days a week, 3 sessions every day, 6 sessions in total, 8 hours in total). After the training and counseling program given to the pregnant women in the experimental group according to the motherhood role theory is completed, a training booklet will be prepared so that they can repeat the information they have learned until birth (for improving the motherhood role). It is planned to give the training booklet at the end of the training in order to ensure continuity in the program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | At the beginning of the study, the pregnant women who applied to the obstetrics clinics and met the sample selection criteria will be divided into the experimental and control groups by randomization method by filling out the Personal Information Form. Motherhood Theory-Based Education Program will be applied to the pregnant women who are allocated to the experimental group. Receives: Behavioral: education and counseling based on maternal role theory |
| Control Group | No intervention | First stage: Pregnant women in the control group will receive routine care. Second stage: Data Collection Form for the follow-up and Birth Process and Results will be filled within the first 24 hours after the birth. Third stage: Follow-up will be done by phone within 4 weeks after birth. Maternal Attachment Scale (MBI), Barkin Maternal Function Inventory will be applied. Fourth stage: At the end of the fourth month postpartum, follow-up counseling will be made by telephone and the Maternal Attachment Scale and the Barkin Maternal Function scale will be filled. Fifth stage: When the study is completed, a training booklet will be given to the mothers in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal attachment
Maternal attachment will be assessed with the Maternal Attachment Inventory. As the score obtained from the scale increases, attachment increases.
Measured: 1-4 mounth
Maternal function
Maternal function will be assessed with the Barkin Maternal Functioning Inventory. As the score obtained from the scale increases, attachment increases.attachment scale. As the score obtained from the scale increases, attachment increases.ores of educational practice based on maternal role theory during pregnancy may change.
Measured: 1-4 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Jul 2023
- Primary completion12 Jan 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal-Fetal RelationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Collaborators
- KAMİLE ALTUNTUĞ
- Responsible party
- Principal investigator, Hafize Dağ Tüzmen, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910346
- Sponsor's protocol ID
- Mercer
- Status last verified
- Aug 2024
- First submitted
- 4 Jun 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training and Counseling Based on Mercer's Maternal Role Theory on Maternal Attachment and Maternal Function: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05910346
- Acronym / sponsor ID
- Mercer
- Conditions
- Maternal-Fetal Relations, Maternal Behavior
- Keywords
- maternal identity, maternal role, being a mother
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Collaborators
- KAMİLE ALTUNTUĞ
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 18 Jun 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.
Motherhood role gain is the composition of social roles and developmental behaviors and attitudes that continue with the formation of motherhood identity development in the postnatal period that started during pregnancy. In many studies, it is stated that mothers should be prepared to transition to motherhood roles in the prenatal period in order to enable them to develop successful motherhood identity. This study will be carried out to determine the effect of structured birth preparation education on the material attachment status and motherhood function according to the theory of motherhood. The study was planned as a single -blind, post -test parallel group randomized controlled experimental study. The universe of the study will form pregnant women who apply to Necmettin Erbakan University Meram Medical Faculty Hospital Birth and Gynecology Polyclinic and Clinic. When the sample of the study was calculated as 95 %confidence interval, 5 %error and 80 %power, a total of 44 cases, 22 for the experimental group and 22 for the control group were found to be suitable for statistical analyzes. In this study, assuming that the loss rates in the literature will be 20 %loss when reference, 28 to the experimental group and 28 to the control group will be included in the initially 56 pregnant studies. The data will be collected using the 'Personal Information Form, Postpartum Period Features Information Form, Maternal Binding Scale and Barkin Maternity Function Inventory. Pregnant women in the experimental group will start in the 32nd gestational week and will be given structured training and counseling according to the theory of motherhood. Pregnant women in the control group will take standard care. Number, percentage, average and standard deviation analysis will be used for descriptive statistics. Parametric and nonparametric tests will be applied according to the compliance of the data for the normal distribution of the data in the study pattern in independent groups and recurrent tests. The results will be tested at P <0.05 significance level. In order to collect the data, Ethical Permission was obtained by the Decision No. 2022/024 from the Ethics Committee of KTO Karatay University Pharmaceutical and Medical Research. Necmettin Erbakan University Meram Medical Faculty Hospital will be obtained from the institution. Before starting to work, verbal and written permissions will be obtained by reading the voluntary information form to all pregnant women. Maternal attachment inventory and Barkin Motherhood Function Scale Writers were permitted via e-mail.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: education and counseling based on maternal role theoryAt the beginning of the study, the pregnant women who applied to the obstetrics clinics and met the sample selection criteria will be divided into the experimental and control groups by randomization method by filling out the Personal Information Form. Motherhood Theory-Based Education Program will be applied to the pregnant women who are allocated to the experimental group. |
| Control Group | No intervention | –First stage: Pregnant women in the control group will receive routine care. Second stage: Data Collection Form for the follow-up and Birth Process and Results will be filled within the first 24 hours after the birth. Third stage: Follow-up will be done by phone within 4 weeks after birth. Maternal Attachment Scale (MBI), Barkin Maternal Function Inventory will be applied. Fourth stage: At the end of the fourth month postpartum, follow-up counseling will be made by telephone and the Maternal Attachment Scale and the Barkin Maternal Function scale will be filled. Fifth stage: When the study is completed, a training booklet will be given to the mothers in the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- At least primary school graduate,
- Between the ages of 18-35,
- At the 30nd week of pregnancy and above,
- Having a single and healthy fetus,
- Pregnant women who are open to communication and cooperation
Key exclusion criteria (7 listed)
- Having a risky pregnancy history (pregnancies under 18 and over 35 years of age, EDT, PROM, Preeclampsia, Eclampsia, Epilepsy, GDM)
- Having a treatment pregnancy (mothers who became pregnant with ART),
- Having a chronic disease (DM, HT, Asthma, Epilepsy, Autoimmune diseases, self-report),
- Having a psychiatric illness (based on self-report and clinical diagnosis),
- Foreign nationals,
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 |
|---|---|---|
| education and counseling based on maternal role theoryPregnant women in the experimental group will be given training and counseling based on the maternal role theory, starting at 32 weeks of gestation (1 week in total, 2 days a week, 3 sessions every day, 6 sessions in total, 8 hours in total). After the training and counseling program given to the pregnant women in the experimental group according to the motherhood role theory is completed, a training booklet will be prepared so that they can repeat the information they have learned until birth (for improving the motherhood role). It is planned to give the training booklet at the end of the training in order to ensure continuity in the program. | Behavioural | Experimental Group |
Primary outcome
Maternal attachment
Time frame: 1-4 mounth
Maternal attachment will be assessed with the Maternal Attachment Inventory. As the score obtained from the scale increases, attachment increases.
Maternal function
Time frame: 1-4 mounth
Maternal function will be assessed with the Barkin Maternal Functioning Inventory. As the score obtained from the scale increases, attachment increases.attachment scale. As the score obtained from the scale increases, attachment increases.ores of educational practice based on maternal role theory during pregnancy may change.
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 21 Aug 2024.
- 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.
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 education and counseling based on maternal role theory in people with Maternal-Fetal Relations and Maternal Behavior, run by KTO Karatay 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 5 inclusion and 7 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 21 Aug 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?
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?
Maternal attachment (time frame: 1-4 mounth). 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 21 Aug 2024.