NCT05313113

Brief Summary

This study was conducted to determine the effect of self-made fetal movement counting and fetal position tracking on prenatal attachment and prenatal distress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

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

Study Start

First participant enrolled

July 15, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

February 7, 2022

Last Update Submit

March 28, 2022

Conditions

Keywords

Prenatal attachmentPregnancyFetal Position TrackingFetal Movement CountDistress

Outcome Measures

Primary Outcomes (2)

  • The mean prenatal attachment level (mean±SD)

    The mean prenatal attachment was assessed using ''Prenatal attachment inventory''. The inventory consists of 21 Likert-type items. Each item is scored between 1 and 4. Therefore, the minimum score of the inventory is 21, while the maximum score of the inventory is 84. The pregnant between 24-28 gestational weeks were filled with face-to-face interviews at the first interview and 30 days after the training.

    between 24-28 gestational weeks and after 30 days

  • The mean pregnancy distress level (mean±SD)

    The mean pregnancy distress was assessed using "Pregnancy Distress Scale".The TPDS consists of 16 items and two sub-dimensions as negative affect and partner involvement. The TPDS is 4-point likert type. Each item is scored between 0 and 3. Thus, the total score of TPDS is ranged between 0 and 48 on the scale. The higher the score, the higher the pregnancy distress. The pregnant between 24-28 gestational weeks were filled with face-to-face interviews at the first interview and 30 days after the training.

    between 24-28 gestational weeks and after 30 days

Study Arms (2)

Experimental group

EXPERIMENTAL

In the first stage, pregnant women were trained to implement fetal movement count and position tracking. The training was provided face to face and lasted 30-45 minutes. How to determine the position of the fetus and I. and II. Leopold maneuvers are also taught. In the second stage, the pregnant women were interviewed twice a week by telephone.Thus, it was provided that pregnant women had fetal tracked at least once a day, at any time of the day, when the fetus was awake and most active, in a suitable position and a comfortable environment, for at least 15-20 minutes continuously for four weeks. Pregnant women phoned the researcher when they wanted. At the same time, the participants continued to their routine prenatal care.

Behavioral: Experimental

Control Group

NO INTERVENTION

The pregnant women continued to their routine prenatal care. No intervention was applied to the pregnant women in addition to their routine prenatal care.The pregnant women were called about whether continuing their routine care or having any problems during the research.

Interventions

ExperimentalBEHAVIORAL

Pregnant women were trained to implement fetal movement count and position tracking. The training was provided face to face and lasted 30-45 minutes. The training content included topics such as setting a comfortable environment and suitable position for the pregnant, when the fetus is active and asleep during the day, how to count and how to evaluate the movements. How to determine the position of the fetus and I. and II. Leopold maneuvers are also taught. In the second stage, the pregnant women were interviewed twice a week by telephone.Thus, it was provided that pregnant women had fetal tracked at least once a day, at any time of the day, when the fetus was awake and most active, in a suitable position and a comfortable environment, for at least 15-20 minutes continuously for four weeks. Pregnant women phoned the researcher when they wanted. At the same time, the participants continued to their routine prenatal care.

Experimental group

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfocused on pregnancy women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • least literate
  • between the ages of 19-35
  • Effective communication
  • first pregnancy
  • having a single fetus
  • Pregnancy week between 24 and 28.

You may not qualify if:

  • Pregnancy using assisted reproductive techniques
  • Having a risky pregnancy (preeclampsia, placenta previa, gestational diabetes etc.)
  • Pregnant women with a chronic disease (heart, systemic, circulatory disorder, psychiatric, etc.) were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38280, Turkey (Türkiye)

Location

Related Publications (1)

  • Badem A, Mucuk S. The effect of self-evaluation of foetal movement and position tracking on prenatal attachment and distress. J Reprod Infant Psychol. 2024 Jun;42(3):439-448. doi: 10.1080/02646838.2022.2117290. Epub 2022 Sep 1.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2022

First Posted

April 6, 2022

Study Start

July 15, 2019

Primary Completion

August 15, 2019

Study Completion

May 20, 2020

Last Updated

April 6, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations