NCT06740682

Brief Summary

Birth is an important period that affects a woman's life physically, psychologically and socially. Although this experience can bring joy, it can also be accompanied by anxiety and fear. Fear of birth is affected by people's past traumatic birth experiences, lack of information, and the transfer of birth experiences experienced by individuals . Birth stories are one of the most accessible and frequently used tools for women to learn about birth. These stories are seen to affect women's fears of birth and their birth preferences .This study will evaluate the impact of Potcost Stories on childbirth-related fear, pain, experiences and mode of delivery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

December 9, 2024

Last Update Submit

December 14, 2024

Conditions

Keywords

Potcost Storiesfearpainexperiencesbirth

Outcome Measures

Primary Outcomes (3)

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

    The Wijma Birth Expectation/Experience Scale Version A (W-DEQ A), developed by K. Wijma et al. in Sweden in 1998, was adapted to Turkish by Körükçü et al. in 2012. The W-DEQ consists of 33 items and is a six-point Likert-type scale. The item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all". The minimum score that can be obtained from the scale is 0, and the maximum score is 165. The cut-off value is 85 points, and a score of 85 and above is expressed as clinical fear. A high total scale score means that the degree of fear experienced is also high. * W-DEQ score ? 37 is mild, * W-DEQ score = 38-65 is moderate, * W-DEQ score = 66-84 is severe, * W-DEQ score ? 85 indicates clinical fear. Questions 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 in the scale are negatively loaded and are calculated by reversing in order to ensure compliance in the measurement. The Cronbach a

    1 MOUNT

  • VASA Pain

    The numerical pain rating scale (NAS) is used to assess pain intensity. In the numerical rating scale, pain is rated between 0 (absence of pain) and 10 (unbearable pain) (Price et al., 1983)

    1 HOUR

  • Birth Experience Questionnaire (CEQ)

    The Birth Experience Questionnaire (CEQ), developed by Dencker et al. in 2010, was adapted to Turkish by Mamuk et al. in 2019. The scale, which was developed to measure women's birth experience in different dimensions, has four sub-dimensions and 22 items. It consists of the Birth process with 8 items, Professional help / Support with 5 items, Perceived Security / Memories with 6 items and Participation in Decisions with 3 items. * Questions 1, 2, 4, 5, 6, 19, 20, 21 in the Birth Process sub-dimension; * Questions 13, 14, 15, 16, 17 in the Professional help / Support sub-dimension; * Questions 3, 7, 8, 9, 18, 22 in the Perceived Security / Memories sub-dimension; * Questions 10, 11, 12 are included in the Participation in Decisions sub-dimension. The first 19 items of the scale are in the four-point Likert type and are scored from 1 to 4. • Completely agree = 1, • Mostly agree = 2, • Partially agree = 3, • Strongly disagree = 4. The last three

    1 HOUR

Study Arms (2)

Control Group

NO INTERVENTION

Potcost Stories

ACTIVE COMPARATOR
Behavioral: Podcast olumlu doğum hikayeler

Interventions

ositive birth stories were listened to by women who gave birth in the hospital included in the study and created with their permission. The podcast recording was done in a single session. These positive birth stories were expertly reviewed by 3 obstetricians and 3 academics. Each podcast content is 10 to 20 minutes (Cai et al., 2023). A WhatsApp reminder msg will be sent so that the stories are not forgotten. In addition, the pregnant woman will be contacted by phone and trained to listen (Cai et al., 2023). Participants will be allowed to listen to the podcasts as much as they want (Cai et al., 2023). After listening to each story, their feedback will be received and the participants' doubts will be clarified. (Cai et al., 2023; Çankaya and Şimşek, 2021; Mousavi et al., 2022). Based on multimedia principles, podcast positive birth experiences will be prepared (Clark and Mayer, 2023). Week 24, Week 30-32, Week 36-38 First story

Potcost Stories

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Those who have completed at least primary school education
  • Those who can speak, understand and write Turkish
  • Those between the ages of 18-35
  • Those who have spontaneous pregnancy
  • Those who volunteer to participate in the study
  • Those who are in the 24th week of pregnancy according to their last menstrual period (LMT) or ultrasound (USG) records
  • Those who have no risk factors
  • Those who have a phone number that can be used for educational interviews
  • Those who attend a pregnancy school

You may not qualify if:

  • Those who have fear of childbirth
  • Those who have chronic and/or psychiatric health problems
  • Those who did not attend at least three sessions of the education program
  • Those who were at risk during the pregnancy at any stage of the study
  • Those who could not be interviewed within the first 24 hours after birth were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Aslantas BN, Cankaya S. The effect of birth ball exercise on labor pain, delivery duration, birth comfort, and birth satisfaction: a randomized controlled study. Arch Gynecol Obstet. 2024 Jun;309(6):2459-2474. doi: 10.1007/s00404-023-07115-4. Epub 2023 Jul 5.

    PMID: 37405439BACKGROUND
  • Alizadeh-Dibazari Z, Abdolalipour S, Mirghafourvand M. The effect of prenatal education on fear of childbirth, pain intensity during labour and childbirth experience: a scoping review using systematic approach and meta-analysis. BMC Pregnancy Childbirth. 2023 Jul 27;23(1):541. doi: 10.1186/s12884-023-05867-0.

    PMID: 37501120BACKGROUND
  • Abadi Marzoni Z, Bakouei F, Aghajani Delavar M, Hamidia A, Sepidarkish M. Midwife-led psycho-education intervention to reduce childbirth fear: a quasi-experimental study. Health Educ Res. 2024 May 11;39(3):245-253. doi: 10.1093/her/cyae017.

    PMID: 38687635BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 18, 2024

Study Start

January 1, 2025

Primary Completion

July 30, 2025

Study Completion

August 30, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share