NCT06377891

Brief Summary

Although birth has a great place in a woman's life, factors such as the woman's education level, personal experiences, social support status, whether the pregnancy is planned or not, the family's attitude towards pregnancy, and socioeconomic status increase the burden of pregnancy and can create a stressful situation for the woman. While the pain that may be experienced during birth, thoughts about the baby's health and postpartum baby care further increase this fear, primiparous women who will give birth for the first time experience many emotions that they cannot define and cannot predict the situations they will encounter during birth. The most important situation that will cause pain during birth is fear. So much so that fear of birth may cause women to avoid pregnancy and increase optional abortions.In particular, fear of birth may increase cesarean delivery rates and also lead to negative maternal outcomes such as poor mental health after birth. Fear experienced during the antenatal period can lead to difficult births, mother-baby attachment problems, and depression. While fear of birth causes depression and anxiety disorders in the postpartum period, it is stated that depression experienced during pregnancy may increase the fear of birth, or fear of birth may be a hidden symptom of depression. It is noted that emotional regulation skills and resilience in pregnant women can be effective strategies in minimizing and managing fear, anxiety, stress, and anxiety. Emotional resilience is defined as the style of coping with stress, the ability to repair oneself, the ability to recover from adverse events quickly, and the state of adapting to a new environment. In particular, individuals with high emotional resilience can protect their physical and mental health and increase their life satisfaction by reducing the negative consequences they experience. With the emotional resilience training given during pregnancy, pregnant women's stress, fear, and anxiety will be reduced, and they will be able to cope better with the difficulties they experience. This research will be conducted to examine the effect of emotional resilience training given to primiparous pregnant women on fear of childbirth and depression.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

April 15, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

April 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

April 15, 2024

Last Update Submit

April 17, 2024

Conditions

Keywords

ResiliencePregnantPrimiparousFear of ChildbirthDepression

Outcome Measures

Primary Outcomes (1)

  • The effect of emotional resilience on fear of birth and depression in primiparous pregnant women.

    To make the effect of emotional resilience training given to primiparous pregnant women on fear of birth and depression during pregnancy and after birth visible with WIJMA-A and WIJMA-B fear of birth scale (Low (score ≤ 37), moderate (38-65), severe (66-84) and clinical fear of birth (≥ 85)) and Edinburgh depression scale (The cut-off point was calculated as 12/13, and women whose total scale score is more than the cut-off point are considered to be in the risk group)

    32-34 gestational weeks - 4 follow-ups until the 6th week postpartum

Study Arms (2)

Emotional Resilience Group

EXPERIMENTAL

Providing emotional resilience training to the experimental group.

Other: Emotional Resilience training

Control group

NO INTERVENTION

There will be no intervention in the control group.

Interventions

Primiparous pregnant women in the experimental group will be given emotional resilience training in the last trimester.

Emotional Resilience Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years of age,
  • Volunteering to participate in the research,
  • Being at the gestational age,
  • Knowing Turkish,
  • Being at least a primary school graduate,
  • Having a single and healthy fetus,
  • Having a WBDRS-A score of 38 and above,
  • Being at least a primary school graduate.
  • Depression score above 12/13,

You may not qualify if:

  • Pregnant women with any risky pregnancy history (Preeclampsia, placenta previa, gestational diabetes mellitus, oligohydramnios and polyhydroamnios, etc.),
  • Those who do not attend at least one of the sessions of the training program,
  • Chronic and/or psychiatric health Pregnant women with problems (based on self-report and clinical diagnosis status) will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayburt State Hospital

Bayburt, 69000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 22, 2024

Study Start

April 16, 2024

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations