Pregnancy RelatedNCT05976776
Effectiveness of a Childbirth and Parenthood Preparation Education in Primigravidas
A study testing The Childbirth and Parenthood Preparation Education in people with Pregnancy Related and Anxiety, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of 148 pregnant women are planned to be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Anxiety
- What is being tested?
- The Childbirth and Parenthood Preparation Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 30 Jun 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literate
- 18-40 years old
- Primigravida
- Those who volunteered to participate in the research
- Pregnant women who do not have communication and mental difficulties
Who cannot join
- Those who do not fill out the entire questionnaire
- Those with risky pregnancy
- Pregnant women with a previous history of psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas
To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of 148 pregnant women are planned to be included in the study. Data will be collected with the 'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of four weeks (a month (each week, once a week in total four sessions)). It is thought that the results of the research will contribute to the welfare of pregnant women by reducing maternal health needs, pregnancy-related anxiety and fetal health anxiety levels.
Read the detailed description
To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of 148 pregnant women are planned to be included in the study. Data will be collected with the 'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of four weeks (a month (each week, once a week in total four sessions)). Within the scope of the "Childbirth and Parenthood Preparation training" program; Physiological and psychological changes in the mother during pregnancy, daily life during pregnancy, smoking, alcohol and substance use during pregnancy, exercise during pregnancy, nutrition and nutritional support during pregnancy, pregnancy follow-ups, routine examinations and immunization, common problems during pregnancy and suggestions for solutions, signs of danger during pregnancy and what to do, risky pregnancies, drug and human medicinal product management during pregnancy, labor process, drug-free methods for coping with labor pain, postpartum period and its characteristics, physiological changes in the mother after birth, psychological changes in puerperium, puerperal role and adaptation, postpartum behaviors , care of the newborn in the postpartum period, postpartum contraception methods will be explained. It is thought that the results of the research will contribute to the welfare of pregnant women by reducing maternal health needs, pregnancy-related anxiety and fetal health anxiety levels.
- Conditions
- Pregnancy Related, Anxiety
- Being tested
- The Childbirth and Parenthood Preparation Education
- Keywords
- Maternal Health Needs, Fetal Health Anxiety, Primiparous women, Childbirth and Parenthood Preparation Education, Pregnancy-Related Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Childbirth and Parenthood Preparation EducationBehavioural
The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of 1 month (each week, once a week in total four sessions).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The Childbirth and Parenthood Preparation Education program Receives: Behavioral: The Childbirth and Parenthood Preparation Education |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Maternal Health Needs
Maternal Health Needs is one of the primary outcomes. This will be measured using 'Maternal Health Needs Scale (MHNS) '. The minimum score that can be obtained from the scale is "23", the maximum score is "115", and as the scale score increases, maternal health needs also increase.
Measured: 1 months
Secondary outcomes (2)
Pregnancy-Related Anxiety Levels
Pregnancy related anxiety level is another outcomes. This will be mesured using "Pregnancy-Related Anxiety Scale- Revision 2". The minimum score that can be obtained from the scale is "11", the maximum score is "55", as the score obtained from the scale increases, the level of anxiety in pregnancy also increases.
Measured: 1 months
Fetal Health Anxiety Levels
Fetal Health Anxiety level is another outcomes. This will be mesured using "Fetal Health Anxiety Inventory (FHAI)". The minimum score that can be obtained from the scale is "0", the maximum score is "42", as the total score from the scale increases, the level of fetal health anxiety increases.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Sep 2023
- Primary completion31 Mar 2024
- Study completion30 Jun 2024
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 Pregnancy RelatedStudies 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
- Model description
- A randomized-controlled trial with pretest-posttest control group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Akca, Amasya University
- Investigators
- Emine İbici Akça, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976776
- Sponsor's protocol ID
- Amasya Un
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Minozzi S, Ambrosi L, Saulle R, Uhm SS, Terplan M, Sinclair JM, Agabio R. Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD015042. doi: 10.1002/14651858.CD015042.pub2.
PubMed 38682758
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas
- ClinicalTrials.gov ID
- NCT05976776
- Acronym / sponsor ID
- Amasya Un
- Conditions
- Pregnancy Related, Anxiety
- Keywords
- Maternal Health Needs, Fetal Health Anxiety, Primiparous women, Childbirth and Parenthood Preparation Education, Pregnancy-Related Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 4 Aug 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.
To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of 148 pregnant women are planned to be included in the study. Data will be collected with the 'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of four weeks (a month (each week, once a week in total four sessions)). It is thought that the results of the research will contribute to the welfare of pregnant women by reducing maternal health needs, pregnancy-related anxiety and fetal health anxiety levels.
Detailed description
To investigate the effect of the Childbirth and Parenthood Preparation Education on Maternal Health Needs, Pregnancy-Related Anxiety and Fetal Health Anxiety in Primigravidas. A total of 148 pregnant women are planned to be included in the study. Data will be collected with the 'Pregnant Identification Form', 'Maternal Health Needs Scale', 'Pregnancy-Related Anxiety Scale-Revision 2' and 'Fetal Health Anxiety Inventory. The "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of four weeks (a month (each week, once a week in total four sessions)). Within the scope of the "Childbirth and Parenthood Preparation training" program; Physiological and psychological changes in the mother during pregnancy, daily life during pregnancy, smoking, alcohol and substance use during pregnancy, exercise during pregnancy, nutrition and nutritional support during pregnancy, pregnancy follow-ups, routine examinations and immunization, common problems during pregnancy and suggestions for solutions, signs of danger during pregnancy and what to do, risky pregnancies, drug and human medicinal product management during pregnancy, labor process, drug-free methods for coping with labor pain, postpartum period and its characteristics, physiological changes in the mother after birth, psychological changes in puerperium, puerperal role and adaptation, postpartum behaviors , care of the newborn in the postpartum period, postpartum contraception methods will be explained. It is thought that the results of the research will contribute to the welfare of pregnant women by reducing maternal health needs, pregnancy-related anxiety and fetal health anxiety levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized-controlled trial with pretest-posttest control group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: The Childbirth and Parenthood Preparation EducationThe Childbirth and Parenthood Preparation Education program |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Literate
- 18-40 years old
- Primigravida
- Those who volunteered to participate in the research
- Pregnant women who do not have communication and mental difficulties
Key exclusion criteria (3 listed)
- Those who do not fill out the entire questionnaire
- Those with risky pregnancy
- Pregnant women with a previous history of psychiatric illness
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 Childbirth and Parenthood Preparation EducationThe "Childbirth and Parenthood Preparation Education" program will be applied to the experimental group for a period of 1 month (each week, once a week in total four sessions). | Behavioural | Experimental group |
Primary outcome
Levels of Maternal Health Needs
Time frame: 1 months
Maternal Health Needs is one of the primary outcomes. This will be measured using 'Maternal Health Needs Scale (MHNS) '. The minimum score that can be obtained from the scale is "23", the maximum score is "115", and as the scale score increases, maternal health needs also increase.
2 secondary outcomes
Pregnancy-Related Anxiety Levels
Time frame: 1 months
Fetal Health Anxiety Levels
Time frame: 1 months
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 3 Jul 2024.
- Derived from this study: PubMed 38682758Minozzi S, Ambrosi L, Saulle R, Uhm SS, Terplan M, Sinclair JM, Agabio R. Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD015042. doi: 10.1002/14651858.CD015042.pub2.
- 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.
Emine İbici Akça principal investigator
Amasya 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 The Childbirth and Parenthood Preparation Education in people with Pregnancy Related and Anxiety, run by Amasya 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 3 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 3 Jul 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?
Levels of Maternal Health Needs (time frame: 1 months). 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 NCT05976776, 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 3 Jul 2024.