CClinicalTrials.gg
CompletedNCT05962866Updated Sep 19, 2024

The Effect of Pregnant Women's Maneuvers on Pregnancy Distress and Perception of Maternity Role"

An interventional study of I and II. Performing Leopold Maneuvers by the pregnant in Pregnancy Related and Mother-Child Relations, sponsored by Sibel ÖZTÜRK. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Sibel ÖZTÜRK · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Pregnancy Related
  • Mother-Child Relations

Keywords

  • Leopold maneuver
  • pregnancy
  • midwifery
  • fetus
03

In context

Lead sponsor

This is the only study on the registry with Sibel ÖZTÜRK as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • 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.

    Other: I and II. Performing Leopold Maneuvers by the pregnant

  • No intervention
    Control: Assigned Interventions standard care group

    No intervention will be made.

Interventions

  • OtherI and II. Performing Leopold Maneuvers by the pregnant

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: two months

07

Study locations

1 site
  • Muş Hasköy Family Health Center
    Muş, 49700, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05962866
Lead sponsor
Sibel ÖZTÜRK
Responsible party
Sibel ÖZTÜRK (Asst. Prof., Ataturk University) — Sponsor-investigator
First posted
Jul 27, 2023
Start date
Jul 28, 2023
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024
Last update
Sep 19, 2024

Study contacts

Songül Kekil
principal investigator · Muş Hasköy Family Health Center
Sibel Öztürk, Asst. Prof.
study director · Ataturk University Faculty of Health Sciences Department of Midwifery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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