Pregnancy RelatedNCT05962866
The Effect of Pregnant Women's Maneuvers on Pregnancy Distress and Perception of Maternity Role"
A study testing I and II. Performing Leopold Maneuvers by the pregnant in people with Pregnancy Related and Mother-Child Relations, run by Sibel ÖZTÜRK at 1 site in Turkey (Türkiye).
Trial summary
The role of motherhood; Motherhood can be defined as a learning process that includes knowledge, skills, attitudes and behaviors of a woman who has been handed down from generation to generation. 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, Mother-Child Relations
- What is being tested?
- I and II. Performing Leopold Maneuvers by the pregnant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2023to 30 Jan 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
- Spontaneous single pregnancy,
- 28th gestational week,
- Over the age of 18, under the age of 40,
- Not having communication difficulties and mental disabilities, Literate,
- Not having any chronic health problems (hypertension, heart disease,
- obesity etc.)
Show all 11Show fewer
- Does not have a psychiatric disease and does not use psychiatric drugs, Exclusion Criteria
- Not open to communication and cooperation during the working period,
- Reluctant to participate in the research,
- Not completing the questionnaires,
- Pregnant women who gave birth prematurely were not included in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregnancy of I. and II. Leopold Manoeuvres Performed by Pregnant Women Under Midwife Supervision Effects on Distress and Perception of Motherhood Role
The role of motherhood; Motherhood can be defined as a learning process that includes knowledge, skills, attitudes and behaviors of a woman who has been handed down from generation to generation. Mother-infant attachment; At the behavioral and emotional level, it is the mother's attachment to her baby, which becomes stronger as the pregnant woman's body changes, her uterus expands and the mother begins to feel fetal movements. The fact that women adopt the role of motherhood throughout pregnancy is very important for attachment behaviors and infant attachment patterns in the early and late postpartum period.
Read the detailed description
It is very important for midwives to implement and teach the interventions that will enable pregnant women to take an active role in this period, in terms of perception of the role of motherhood and pregnancy distress. . The literature provides a data source for leopard maneuvers. However, I and II. There is no study on the effect of Leopold maneuvers on pregnancy distress and the perception of maternal role. This study, which is planned to support and develop awareness in this area, is important in terms of literature.
- Conditions
- Pregnancy Related, Mother-Child Relations
- Being tested
- I and II. Performing Leopold Maneuvers by the pregnant
- Keywords
- Leopold maneuver, pregnancy, midwifery, fetus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I and II. Performing Leopold Maneuvers by the pregnantOther
24-32 and 32-38 days of pregnancy by the pregnant woman. 1st and 2nd leoppold maneuvers are performed by the pregnant woman, 2 times between weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experiment: Have pregnant women perform the 1st and 2nd Leopold Maneuvers | Experimental | Voluntary information form will be read to those who want to participate in the research, verbal and written permissions will be obtained and information will be given about fetal development and Leopold maneuvers in the pregnant follow-up room of the family health center. This transaction is 28-32. 32-38 at the next follow-up at gestational weeks. Pregnancy will be carried out with the same procedure. Receives: Other: I and II. Performing Leopold Maneuvers by the pregnant |
| Control: Assigned Interventions standard care group | No intervention | No intervention will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring pregnancy distress of pregnant women
The Cronbach Alpha value of the scale was found to be 0.83. The scale, which can be applied to pregnant women who are twelve weeks and older, consists of 16 items and is graded as a 4-point Likert scale. The total score that can be obtained from the scale ranges from 0 to 48. A total score of 28 and above according to the cut-off point indicates that the pregnant woman is at risk for distress. The scale has 2 sub-dimensions as "negative affect" consisting of 11 items and "partner participation" consisting of 5 items. Items 1, 2, 4, 8 and 15 in the scale belong to peer involvement, other items belong to negative affect.
Measured: two months
Secondary outcomes (1)
Measuring pregnant women's perception of maternal role
The internal consistency reliability of the scale was found to be between 0.81-0.85. The validity and reliability study of the scale was adapted to Turkish society by Çalışır The scale consists of 11 semantic opposite adjective pairs with 22 items and seven points, which analyze the concept of Me as a Mother. These 11 items are distributed within the 22 item opposite adjective pairs in the scale. Three items were evaluated with reverse scoring to avoid the possibility of bias while the participant was answering the questions. Items 3, 7 and 8 were evaluated over 1 point instead of 7 points. The lowest score is 11 and the highest score is 77. High total scores from the scale indicate positive motherhood self-assessment. The Cronbach Alpha reliability coefficient of the Semantic Difference Scale-Me as a Mother scale was determined as 0.73-0.74.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start28 Jul 2023
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
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.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel ÖZTÜRK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sibel ÖZTÜRK, Ataturk University
- Investigators
- Songül Kekil, Principal investigator, Muş Hasköy Family Health CenterSibel Öztürk, Asst. Prof., Study director, Ataturk University Faculty of Health Sciences Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962866
- Sponsor's protocol ID
- Ataturk University SOZTURK0003
- Status last verified
- Sep 2024
- First submitted
- 19 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy of I. and II. Leopold Manoeuvres Performed by Pregnant Women Under Midwife Supervision Effects on Distress and Perception of Motherhood Role
- ClinicalTrials.gov ID
- NCT05962866
- Acronym / sponsor ID
- Ataturk University SOZTURK0003
- Conditions
- Pregnancy Related, Mother-Child Relations
- Keywords
- Leopold maneuver, pregnancy, midwifery, fetus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sibel ÖZTÜRKUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 27 Jul 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 role of motherhood; Motherhood can be defined as a learning process that includes knowledge, skills, attitudes and behaviors of a woman who has been handed down from generation to generation. Mother-infant attachment; At the behavioral and emotional level, it is the mother's attachment to her baby, which becomes stronger as the pregnant woman's body changes, her uterus expands and the mother begins to feel fetal movements. The fact that women adopt the role of motherhood throughout pregnancy is very important for attachment behaviors and infant attachment patterns in the early and late postpartum period.
Detailed description
It is very important for midwives to implement and teach the interventions that will enable pregnant women to take an active role in this period, in terms of perception of the role of motherhood and pregnancy distress. . The literature provides a data source for leopard maneuvers. However, I and II. There is no study on the effect of Leopold maneuvers on pregnancy distress and the perception of maternal role. This study, which is planned to support and develop awareness in this area, is important in terms of literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment: Have pregnant women perform the 1st and 2nd Leopold Maneuvers | Experimental | Other: I and II. Performing Leopold Maneuvers by the pregnantVoluntary information form will be read to those who want to participate in the research, verbal and written permissions will be obtained and information will be given about fetal development and Leopold maneuvers in the pregnant follow-up room of the family health center. This transaction is 28-32. 32-38 at the next follow-up at gestational weeks. Pregnancy will be carried out with the same procedure. |
| Control: Assigned Interventions standard care group | No intervention | –No intervention will be made. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Spontaneous single pregnancy,
- 28th gestational week,
- Over the age of 18, under the age of 40,
- Not having communication difficulties and mental disabilities, Literate,
- Not having any chronic health problems (hypertension, heart disease,
Key exclusion criteria (0 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 |
|---|---|---|
| I and II. Performing Leopold Maneuvers by the pregnant24-32 and 32-38 days of pregnancy by the pregnant woman. 1st and 2nd leoppold maneuvers are performed by the pregnant woman, 2 times between weeks. | Other | Experiment: Have pregnant women perform the 1st and 2nd Leopold Maneuvers |
Primary outcome
Measuring pregnancy distress of pregnant women
Time frame: two months
The Cronbach Alpha value of the scale was found to be 0.83. The scale, which can be applied to pregnant women who are twelve weeks and older, consists of 16 items and is graded as a 4-point Likert scale. The total score that can be obtained from the scale ranges from 0 to 48. A total score of 28 and above according to the cut-off point indicates that the pregnant woman is at risk for distress. The scale has 2 sub-dimensions as "negative affect" consisting of 11 items and "partner participation" consisting of 5 items. Items 1, 2, 4, 8 and 15 in the scale belong to peer involvement, other items belong to negative affect.
1 secondary outcome
Measuring pregnant women's perception of maternal role
Time frame: two 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 19 Sep 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.
Songül Kekil principal investigator
Muş Hasköy Family Health Center
Sibel Öztürk, Asst. Prof. study director
Ataturk University Faculty of Health Sciences Department of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I and II. Performing Leopold Maneuvers by the pregnant in people with Pregnancy Related and Mother-Child Relations, run by Sibel ÖZTÜRK 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 11 inclusion and 0 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 19 Sep 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?
Measuring pregnancy distress of pregnant women (time frame: two months). 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 19 Sep 2024.