Pregnancy RelatedNCT06009887
Motivational Interview in Primiparous Pregnants With Low Belief in Normal Birth
A study testing Motivational Interview in people with Pregnancy Related, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effect of motivational interviews made with primiparous pregnant women with low belief in normal birth on medical and natural birth belief. This randomized controlled study was conducted in a randomized controlled manner with a total of 148 pregnant women who applied to the obstetrics… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 15 Sep 2021
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a low level of belief and tendency towards normal birth according to the Normal Birth Belief Scale (between 24-56 points),
- Primiparous pregnant,
- According to the calculations made by USG of the pregnant women who do not know the last menstruation date or the last menstruation date, 24-36 days of pregnancy. in the week,
- Pregnant women who volunteered were included in the sample of the study.
Who cannot join
- Premature birth,
- Having any risk diagnosed during pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios),
- Contraindications for normal vaginal delivery
- Developing cesarean indication,
- Not completing MG sessions,
- Pregnant women with deficiencies or errors in any of the forms in which the data were obtained were excluded from the sample.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Midwifery, Faculty of Health Sciences Sutcuimam University
Kahramanmaraş, Onikişubat
About this study
Official title: The Effect of Motivational Interviews of Primiparous Pregnants With Low Belief in Normal Birth on Medical and Natural Birth Beliefs
This study aims to determine the effect of motivational interviews made with primiparous pregnant women with low belief in normal birth on medical and natural birth belief. This randomized controlled study was conducted in a randomized controlled manner with a total of 148 pregnant women who applied to the obstetrics outpatient clinic of a hospital in eastern Turkey (74 trials, 74 controls). In the study, a total of four sessions of motivational interviews were conducted with the primiparous pregnant women in the experimental group, one week apart. No intervention was applied to the women in the control group. Research data Personal Information Form, Belief Scale for Normal Delivery (BSND) and Birth Beliefs (Natural and medical birth belief) Scale (BBS) were used. Descriptive statistics, Pearson's chi-square test, and dependent and independent t-test were used to analyze the data.
- Conditions
- Pregnancy Related
- Being tested
- Motivational Interview
- Keywords
- Pregnancy, Natural birth belief, Medical birth belief, Motivational interview.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewBehavioural
Motivational interviewing is a collaborative speaking style to strengthen one's own motivation and commitment to change. Motivational interviewing is not a technique but a fundamental therapeutic style that does not try to make people change their behavior against their will. Proven to be effective in many areas of healthcare, motivational interviewing is widely used to help people resolve their indecision about change, explore their concerns, and set their own goals. The purpose of the motivational interviews conducted in the study is to increase the belief in normal and natural birth by enabling pregnant women to understand the factors that affect their low belief in normal birth, to take action for change and to believe in change, and to minimize the practices that cause medicalization of birth such as cesarean section by reducing medical birth beliefs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: İntervention Group | Experimental | Motivational interviewing is a counseling approach that pays special attention to the language of change, adopts a collaborative, goal-oriented communication style and aims to strengthen personal motivation and commitment to this change, revealing and discovering the reasons for the change in one's own, in an atmosphere of acceptance and empathy. Receives: Behavioral: Motivational Interview |
| No Intervention: Control Group | No intervention | No interventions were made for those in the control group other than routine hospital practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Belief Scale for Normal Delivery (BSND)
It was developed to evaluate the beliefs and tendencies of pregnant women towards normal birth. The scale is a five-point Likert type and is scored as I completely agree (5), agree (4), undecided (3), disagree (2), strongly disagree (1). A minimum of 24 and a maximum of 120 points can be obtained from the scale. If the total score from the scale is between 24 and 56, low, between 57 and 88, moderate, and between 89 and 120, high-level beliefs and tendency towards normal birth are in question. As the average score obtained from the scale increases, the beliefs and tendencies of pregnant women about normal birth increase.
Measured: up to 4 weeks
Birth Beliefs (Natural and medical birth belief) Scale (BBS)
While one of the sub-dimensions of the scale used to evaluate the basic belief levels of women about childbirth evaluates birth as a natural process, the other sub-dimension considers birth as a medical/medical process. The scale consists of 11 items in total, including 5 items (items 3, 5, 7, 8, and 11) for the belief in the natural process of birth and 6 items (items 1, 2, 4, 6, 9, and 10) for the belief in the medical/medical process. consists of. The scale score is obtained by dividing the total score of the items belonging to each sub-dimension by the number of items belonging to that sub-dimension. The group with a high numerical value in the arithmetic mean result constitutes the birth belief of the woman. In this Likert-type scale, each item is scored between 1 and 5 scales. The option "strongly disagree" receives 1 point, while the option "strongly agree" receives 5 points.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start15 Feb 2021
- Primary completion20 Feb 2021
- Study completion15 Sep 2021
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.
- More trials run by Inonu 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem KARAKAYALI AY, Inonu University
- Investigators
- Çiğdem KARAKAYALI AY, Principal investigator, Department of Midwifery, Faculty of Health Sciences, Sutcuimam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009887
- Sponsor's protocol ID
- 2020/1198
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers. Because the institution where the research was conducted does not allow this.
Publications
Rasouli M, AtashSokhan G, Keramat A, Khosravi A, Fooladi E, Mousavi SA. The impact of motivational interviewing on participation in childbirth preparation classes and having a natural delivery: a randomised trial. BJOG. 2017 Mar;124(4):631-639. doi: 10.1111/1471-0528.14397. Epub 2016 Nov 10.
PubMed 27862837
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviews of Primiparous Pregnants With Low Belief in Normal Birth on Medical and Natural Birth Beliefs
- ClinicalTrials.gov ID
- NCT06009887
- Acronym / sponsor ID
- 2020/1198
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Natural birth belief, Medical birth belief, Motivational interview.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 24 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.
This study aims to determine the effect of motivational interviews made with primiparous pregnant women with low belief in normal birth on medical and natural birth belief. This randomized controlled study was conducted in a randomized controlled manner with a total of 148 pregnant women who applied to the obstetrics outpatient clinic of a hospital in eastern Turkey (74 trials, 74 controls). In the study, a total of four sessions of motivational interviews were conducted with the primiparous pregnant women in the experimental group, one week apart. No intervention was applied to the women in the control group. Research data Personal Information Form, Belief Scale for Normal Delivery (BSND) and Birth Beliefs (Natural and medical birth belief) Scale (BBS) were used. Descriptive statistics, Pearson's chi-square test, and dependent and independent t-test were used to analyze the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: İntervention Group | Experimental | Behavioral: Motivational InterviewMotivational interviewing is a counseling approach that pays special attention to the language of change, adopts a collaborative, goal-oriented communication style and aims to strengthen personal motivation and commitment to this change, revealing and discovering the reasons for the change in one's own, in an atmosphere of acceptance and empathy. |
| No Intervention: Control Group | No intervention | –No interventions were made for those in the control group other than routine hospital practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a low level of belief and tendency towards normal birth according to the Normal Birth Belief Scale (between 24-56 points),
- Primiparous pregnant,
- According to the calculations made by USG of the pregnant women who do not know the last menstruation date or the last menstruation date, 24-36 days of pregnancy. in the week,
- Pregnant women who volunteered were included in the sample of the study.
Key exclusion criteria (6 listed)
- Premature birth,
- Having any risk diagnosed during pregnancy (such as preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios),
- Contraindications for normal vaginal delivery
- Developing cesarean indication,
- Not completing MG sessions,
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 InterviewMotivational interviewing is a collaborative speaking style to strengthen one's own motivation and commitment to change. Motivational interviewing is not a technique but a fundamental therapeutic style that does not try to make people change their behavior against their will. Proven to be effective in many areas of healthcare, motivational interviewing is widely used to help people resolve their indecision about change, explore their concerns, and set their own goals. The purpose of the motivational interviews conducted in the study is to increase the belief in normal and natural birth by enabling pregnant women to understand the factors that affect their low belief in normal birth, to take action for change and to believe in change, and to minimize the practices that cause medicalization of birth such as cesarean section by reducing medical birth beliefs. | Behavioural | Experimental: İntervention Group |
Primary outcome
Belief Scale for Normal Delivery (BSND)
Time frame: up to 4 weeks
It was developed to evaluate the beliefs and tendencies of pregnant women towards normal birth. The scale is a five-point Likert type and is scored as I completely agree (5), agree (4), undecided (3), disagree (2), strongly disagree (1). A minimum of 24 and a maximum of 120 points can be obtained from the scale. If the total score from the scale is between 24 and 56, low, between 57 and 88, moderate, and between 89 and 120, high-level beliefs and tendency towards normal birth are in question. As the average score obtained from the scale increases, the beliefs and tendencies of pregnant women about normal birth increase.
Birth Beliefs (Natural and medical birth belief) Scale (BBS)
Time frame: Baseline and 4 weeks
While one of the sub-dimensions of the scale used to evaluate the basic belief levels of women about childbirth evaluates birth as a natural process, the other sub-dimension considers birth as a medical/medical process. The scale consists of 11 items in total, including 5 items (items 3, 5, 7, 8, and 11) for the belief in the natural process of birth and 6 items (items 1, 2, 4, 6, 9, and 10) for the belief in the medical/medical process. consists of. The scale score is obtained by dividing the total score of the items belonging to each sub-dimension by the number of items belonging to that sub-dimension. The group with a high numerical value in the arithmetic mean result constitutes the birth belief of the woman. In this Likert-type scale, each item is scored between 1 and 5 scales. The option "strongly disagree" receives 1 point, while the option "strongly agree" receives 5 points.
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 24 Aug 2023.
- Results publication: PubMed 27862837Rasouli M, AtashSokhan G, Keramat A, Khosravi A, Fooladi E, Mousavi SA. The impact of motivational interviewing on participation in childbirth preparation classes and having a natural delivery: a randomised trial. BJOG. 2017 Mar;124(4):631-639. doi: 10.1111/1471-0528.14397. Epub 2016 Nov 10.
- The impact of motivational interviewing on participation in childbirth preparation classes and having a natural delivery: a randomised trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers. Because the institution where the research was conducted does not allow this.
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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.
Çiğdem KARAKAYALI AY principal investigator
Department of Midwifery, Faculty of Health Sciences, Sutcuimam 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 Motivational Interview in people with Pregnancy Related, run by Inonu 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 6 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 24 Aug 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?
Belief Scale for Normal Delivery (BSND) (time frame: up to 4 weeks). 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 NCT06009887, 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 24 Aug 2023.