- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05962866
The Effect of Pregnant Women's Maneuvers on Pregnancy Distress and Perception of Maternity Role"
September 17, 2024 updated by: Sibel ÖZTÜRK
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Muş, Turkey, 49700
- Muş Hasköy Family Health Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experiment: Have pregnant women perform the 1st and 2nd Leopold Maneuvers
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.
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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.
Other Names:
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No Intervention: Control: Assigned Interventions standard care group
No intervention will be made.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
two months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring pregnant women's perception of maternal role
Time Frame: two months
|
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.
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two months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Songül Kekil, Muş Hasköy Family Health Center
- Study Director: Sibel Öztürk, Asst. Prof., Ataturk University Faculty of Health Sciences Department of Midwifery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 28, 2023
Primary Completion (Actual)
January 30, 2024
Study Completion (Actual)
January 30, 2024
Study Registration Dates
First Submitted
July 19, 2023
First Submitted That Met QC Criteria
July 19, 2023
First Posted (Actual)
July 27, 2023
Study Record Updates
Last Update Posted (Actual)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 17, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Ataturk University SOZTURK0003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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