NCT05361265

Brief Summary

Purpose: This study aimed to determine the effect of fetal movement counting on prenatal maternal attachment and distress in pregnancy. Methods: This is a quasi-experimental study. The population of the study consisted of of 60 primigravida pregnant women (30 experimental and 30 control groups) being in 28 to 32 weeks gestation. The Prenatal Attachment Inventory (PAI) and the Tilburg Pregnancy Distress Scale (TPDS) used for data collection. After the pre-tests (28 to 32 weeks gestation), the experimental group were trained about fetal movement counting. The experimental group performed fetal movement counting for at least four to six weeks. The post-tests were filled in 32 to 38 weeks gestation. The control group received only pre-tests and post-test in the same weeks gestation with the experimental group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

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

November 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 29, 2022

Last Update Submit

April 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • prenatal maternal attachment

    the Prenatal Attachment Inventory: The inventory was developed to explain the feelings, thoughts, and situations of women during pregnancy and to determine their attachment levels to the baby in the prenatal period \[17\]. The scale consists of 21 items in total. In the 4-point Likert scale, each item can score between 1 and 4 points (1: Never, 2: Sometimes, 3: Frequent, 4: Always). The highest score of the scale is 84, the lowest score is 21, and the high scale score indicates the high level of prenatal attachment.

    4-6 weeks

  • distress in pregnancy

    the Tilburg Pregnancy Distress Scale: The scale was developed for the diagnosis of distress in pregnancy \[11\]. The scale consists of a total of 16 items. The scale has two subscales. Negative Affect subscale consists of 12 items including fear, anxiety and negative perceptions regarding pregnancy, childbirth and the postpartum period. Partner Involvement subscale consists of 4 items related to spousal support during pregnancy. The scale is a four-point Likert type and each item is scored between 1 and 3 (0: very often, 1: quite often, 2: sometimes, and 3: rarely or never). The points 3.5,6,7,9,10,11,12,13,14 and 16 are interpreted by reversing them. The highest score of the scale is 48 and the lowest score is 0. A high score from the scale indicates that pregnant women are at risk for distress.

    4-6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

pregnant women were trained about fetal movements and fetal movement counting was taught. The training was given verbally. Pregnant women were asked to perform ten fetal movements by counting once a day after any meal, lying in the left side position for one hour. When ten fetal movements could not be reached within the first hour, pregnant women were instructed to count the fetal movements for one hour after walking for five minutes. When ten fetal movement counts could not be obtained at the end of two hours, they were asked to apply to the hospital immediately. Pregnant women were expected to perform fetal movement counting after the same meal every day (breakfast, lunch or dinner) and record the start and end times of the ten movements on the Fetal Movement Monitoring Card.

Other: fetal movement counting

Control Group

NO INTERVENTION

Routine follow up

Interventions

pregnant women were trained about fetal movements and fetal movement counting was taught. Pregnant women were asked to perform ten fetal movements by counting once a day. In the application of the study, it was ensured that the pregnant women in the experimental group performed fetal movement counting for at least four to six weeks. In this context, pregnant women were called every week to monitor and to motivate them to continue the counting.

Experimental Group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being in 28 to 32 gestation weeks
  • primigravidity
  • at least literate

You may not qualify if:

  • illiteration
  • chronic or psychiatric disease
  • communication disability (speech, hearing, mental)
  • risky pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 6450, Turkey (Türkiye)

Location

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
Assoc Prof

Study Record Dates

First Submitted

April 29, 2022

First Posted

May 4, 2022

Study Start

November 1, 2018

Primary Completion

February 18, 2019

Study Completion

February 18, 2019

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations