NCT06313723

Brief Summary

This study was planned to determine the effect of prenatal education given via podcast to nulliparous pregnant women who applied to the Non-Stress Test Polyclinic of the University of Health Sciences, Istanbul Bagcilar Training and Research Hospital, on maternal anxiety, fear and fetal attachment. The research, planned in a randomized controlled quasi-experimental design, will be carried out with nulliparous pregnant women (n:104) who apply to the Non-Stress Test polyclinic of the University of Health Sciences Istanbul Bağcılar Training and Research Hospital. Pregnant women who voluntarily participate in the research will be divided into intervention (n: 52) and control (n: 52) groups according to the computer-assisted simple random sampling technique. The intervention group, nulliparous pregnant women, will listen to 3 podcasts of 5-6 minutes. Pregnant women in the control group will be given a booklet on the pregnancy and birth process from the Ministry of Health as part of routine care. "Personal Information Form", "State-Trait Anxiety Inventory", "Wijma Birth Expectation/Experience Scale Version A" and "Prenatal Attachment Inventory" will be applied to all pregnant women included in the study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

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
not yet recruiting

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

March 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 9, 2024

Last Update Submit

March 9, 2024

Conditions

Keywords

podcastpregnancynon-stress testingfear of birthprenatal attachmentanxiety

Outcome Measures

Primary Outcomes (4)

  • Introductory Information Form

    Reported based on the literature, the form includes questions regarding socio-demographic data and obstetric characteristics of nulliparous pregnant women. Regarding demographic characteristics, the form includes age, gestational age, education level, income may change, spousal support, spouse and individual baby wish status, prenatal follow-up numbers, pregnancy planning status, prenatal education and information availability and where it was obtained. has been given.

    10 minutes

  • State-Trait Anxiety Inventory(D-SKE)

    It contains two separate scales: State Anxiety Inventory (SCI) and Trait Anxiety Inventory (SCI), which consist of a total of 40 items. There are two types of expressions in D-SKE. Direct expressions express negative emotions, while reverse expressions express positive emotions. In the DCI, the reverse statements are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. In SCI, reverse statements constitute items 21, 26, 27, 30, 33, 36 and 39. After the total weights of direct and reverse expressions are found separately, the total weight score of reverse expressions is subtracted from the total weight score obtained for direct expressions. A predetermined and unchanging value is added to this number. This unchanged value is 50 for DKE and 35 for SKE. The final value obtained is the individual's anxiety score. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.

    10 minutes

  • Wijma Birth Expectation/Experience Scale Version A (W-DEQ A)

    The scale consists of 33 items. The answers on the scale are numbered from 0 to 5 and are in a six-point Likert type. 0 means "completely" and 5 means "not at all". The minimum score that can be obtained from the scale is 0 and the maximum score is 165. It is calculated by reversing items 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27, 31 of the scale. It is stated that as the score obtained from the scale increases, the fear of birth experienced by women increases. W-DEQ A scores on the scale; women who have low degree of fear of childbirth (W-DEQ A score ≤37), women who have moderate fear of childbirth (those with W-DEQ A score=38-65), women who have severe fear of childbirth (W-DEQ A score=66-84). ) and those with clinical degree of fear of childbirth (W-DEQ A score ≥85).

    10 minutes

  • Prenatal Attachment Inventory (PBI)

    PBI was developed to explain the thoughts, feelings and situations experienced by women during pregnancy and to determine the level of attachment to the baby in the prenatal period and consists of a total of 21 items. Each item in the PBI is a four-point Likert-type scale with a score between 1 and 4. In PBI, "Never" is scored as 1, "Sometimes" as 2, "Frequently" as 3, and "Always" as 4. A minimum of 21 and a maximum of 84 points can be obtained from PBI. The increase in the score obtained from the PBI indicates that the attachment level of the pregnant woman also increases.

    10 minutes

Secondary Outcomes (3)

  • State-Trait Anxiety Inventory(D-SKE)

    10 minutes

  • Wijma Birth Expectation/Experience Scale Version A (W-DEQ A)

    10 minutes

  • Prenatal Attachment Inventory (PBI)

    10 minutes

Study Arms (2)

İntervention group (n:52)

EXPERIMENTAL

Pregnant women assigned to the intervention group (52) will be listened to podcasts on a Samsung Galaxy J7 Prime brand phone while undergoing a 20-minute NST procedure.Pregnant women in the intervention group will be made to listen to 3 podcasts consisting of 3 modules lasting an average of 5-6 minutes during the Non-Stress Test. After the podcast is prepared, it will be edited in line with expert opinion and its final version will be given.

Other: Prenatal education management delivered via podcast

Control group (n:52)

NO INTERVENTION

Pregnant women assigned to the control group were given T.R. treatment within the scope of routine care. The Ministry of Health's "Pregnancy and Birth Process" booklet will be given and the pregnant woman's questions will be answered on the topics she wants to get information about.

Interventions

Pregnant women assigned to the intervention group (52) will be listened to podcasts on a Samsung Galaxy J7 Prime brand phone while undergoing a 20-minute NST procedure

İntervention group (n:52)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being primigravida
  • Speaking and understanding Turkish
  • To be literate
  • Being a pregnant woman admitted to Istanbul Bağcılar Training and Research Hospital Non-Stress Test outpatient clinic or obstetrics and gynaecology open observation department,
  • to 32 weeks of gestation in nulliparous pregnant women
  • Singleton pregnancy

You may not qualify if:

  • Pregnant women diagnosed with high-risk pregnancy
  • Fetal-obstetric complement complement (preterm labor, hypertension, diabetes, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Assoc. Prof. Dr. Yasemin AYDIN KARTAL

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant) Which of the participants is the control or intervention group will be selected by randomization.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled single-blind quasi-experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

March 9, 2024

First Posted

March 15, 2024

Study Start

April 1, 2024

Primary Completion

August 30, 2024

Study Completion

October 31, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations