Pregnancy RelatedNCT06332924
Primipara Pregnant Women and Motivational Interview
A study testing motivational discussion group in people with Pregnancy Related, run by Saglik Bilimleri Universitesi.
Trial summary
The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- motivational discussion group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria:Must be between the ages of 20-35, have a primipara pregnancy (30-34 weeks of gestation), be a Turkish citizen, have no history of risky pregnancy, have no psychological disorders, and wish to participate in the study voluntarily.
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Exclusion Criteria:Having an unplanned or involuntary pregnancy, having a threat of premature birth, wanting to leave the job at any time.
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Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Positive Birth Motivational Education on the Perception of Traumatic Birth in Primipara Pregnant Women
The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences.
This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data.
- Conditions
- Pregnancy Related
- Being tested
- motivational discussion group
- Keywords
- Positive birth, Motivational interviewing training, Primiparous pregnant women, Perception of traumatic birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational discussion groupBehavioural
Also called control group
There will be 3 interviews with the motivational interview group, one week apart.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing group | Experimental | The patients in the intervention group will be informed about the study, and after the purpose and method of the study are explained, their consent will be obtained and the "Pregnant Information Form" will be applied.
* There will be 3 meetings for both groups, one week apart. Interviews will include primipara pregnant women in their 30th, 32nd and 34th weeks of pregnancy.
* Preliminary tests will be conducted before the interviews.
* After the interviews are completed, final tests will be carried out and the study will be terminated.
* Motivational Interviewing Training for the intervention group will be prepared in detail, with the aim of answering the pregnant woman's questions, and with methods that are relevant to her needs and interests by providing body awareness. Receives: Behavioral: motivational discussion group |
| Control group: | No intervention | Scales will be applied to the control group as pre-test and post-test with a 2-week interval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primipara Pregnant Women and Traumatic Birth
motivational interviewing
Measured: Once a week for 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- In the project, it was calculated that the experimental and control groups should have at least 30 observations each, and the sample of the study was calculated as 60 pregnant women. It was aimed to interview a total of 60 pregnant women, 30 in the control group and 30 in the experimental group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enzel Köksaldı, Saglik Bilimleri Universitesi
- Investigators
- enzel köksaldı, Study director, SağlıkBilimleriU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332924
- Sponsor's protocol ID
- 2023/19
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive Birth Motivational Education on the Perception of Traumatic Birth in Primipara Pregnant Women
- ClinicalTrials.gov ID
- NCT06332924
- Acronym / sponsor ID
- 2023/19
- Conditions
- Pregnancy Related
- Keywords
- Positive birth, Motivational interviewing training, Primiparous pregnant women, Perception of traumatic birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 27 Mar 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.
The first birth is the most important moment a woman experiences in her life as she embarks on her motherhood journey. Waiting for the birth of a new life can be very exciting for mothers. Positive birth is an approach that asks the woman to approach her birth story from a positive perspective and to have a stronger, more impressive and positive birth experience. Primipara pregnant women especially benefit from and need this positive birth approach. Motivational interviews are interviews conducted to support positive births and to help women develop a positive attitude towards their birth experiences.
This planned study was planned as a randomized controlled trial with pre-test and post-test measurements, with the aim of determining the level of traumatic birth perception in primipara women who were given or not given training and examining the effects of positive birth motivational education by taking into account the need for education with numerical data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In the project, it was calculated that the experimental and control groups should have at least 30 observations each, and the sample of the study was calculated as 60 pregnant women. It was aimed to interview a total of 60 pregnant women, 30 in the control group and 30 in the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing group | Experimental | Behavioral: motivational discussion groupThe patients in the intervention group will be informed about the study, and after the purpose and method of the study are explained, their consent will be obtained and the "Pregnant Information Form" will be applied. * There will be 3 meetings for both groups, one week apart. Interviews will include primipara pregnant women in their 30th, 32nd and 34th weeks of pregnancy. * Preliminary tests will be conducted before the interviews. * After the interviews are completed, final tests will be carried out and the study will be terminated. * Motivational Interviewing Training for the intervention group will be prepared in detail, with the aim of answering the pregnant woman's questions, and with methods that are relevant to her needs and interests by providing body awareness. |
| Control group: | No intervention | –Scales will be applied to the control group as pre-test and post-test with a 2-week interval. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| motivational discussion groupAlso: control groupThere will be 3 interviews with the motivational interview group, one week apart. | Behavioural | Motivational interviewing group |
Primary outcome
Primipara Pregnant Women and Traumatic Birth
Time frame: Once a week for 3 weeks
motivational interviewing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
enzel köksaldı study director
SağlıkBilimleriU
Questions about this trial
What is this clinical trial studying?
A study testing motivational discussion group in people with Pregnancy Related, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact enzel köksaldı (+905312821841, enzelkksld@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primipara Pregnant Women and Traumatic Birth (time frame: Once a week for 3 weeks). 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 27 Mar 2024.