NCT05962866

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

July 19, 2023

Last Update Submit

September 17, 2024

Conditions

Pregnancy RelatedMother-Child Relations

Keywords

Leopold maneuverpregnancymidwiferyfetus

Outcome Measures

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.

    two months

Secondary Outcomes (1)

  • Measuring pregnant women's perception of maternal role

    two months

Study Arms (2)

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.

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

Control: Assigned Interventions standard care group

NO INTERVENTION

No intervention will be made.

Interventions

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.

Experiment: Have pregnant women perform the 1st and 2nd Leopold Maneuvers

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbeing pregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Spontaneous single pregnancy,
  • th 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.)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muş Hasköy Family Health Center

Muş, 49700, Turkey (Türkiye)

Location

Study Officials

  • Songül Kekil

    Muş Hasköy Family Health Center

    PRINCIPAL INVESTIGATOR

  • Sibel Öztürk, Asst. Prof.

    Ataturk University Faculty of Health Sciences Department of Midwifery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
statistician
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

July 28, 2023

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)