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Recruiting NCT07542392

Effects of Midwife-guided biırth Affirmation Cards on Labor Process and Experience ın Primigravidas

No phase Interventional Duration of Labor Labor Pain Fear of Childbirth Control (Internet Only)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Midwife-Guided Birth Affirmation Cards.
Who it may be relevant to
Registry conditions: Duration of Labor, Labor Pain, Fear of Childbirth, Control (Internet Only). Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Midwife-Guided Birth Affirmation Cards on Labor Duration, Pain, Fear, Control and Perceived Support in Primigravidas: A Randomized Controlled Study

Overview

The aim of this study is to evaluate the effects of midwife-guided birth affirmation cards on labor duration, pain level, fear of childbirth, perceived control, and perceived support in primigravidas. The study seeks to determine whether this non-pharmacological approach used during labor improves the childbirth experience. Accordingly, the research aims to answer the question: "Do midwife-guided birth affirmation cards affect labor duration and the childbirth experience, including pain, fear, perceived control, and perceived support, in primigravidas?"

Detailed description

This study is designed to investigate the use of birth affirmation cards, implemented under midwife guidance, as a non-pharmacological, low-cost, and feasible approach to support the labor process in primigravid women. Labor is not only a physiological process but also a multidimensional experience involving cognitive, emotional, and behavioral responses. Supporting a woman's sense of safety, enhancing coping capacity, and promoting a positive perception of childbirth are critical for improving the overall quality of the birth experience.

Birth affirmation cards are structured tools consisting of brief, positive, and empowering statements aimed at activating internal resources, strengthening self-efficacy, and fostering a positive cognitive framework toward childbirth. The implementation of these cards under midwife guidance ensures not only the delivery of supportive content but also continuous professional support, encouraging the active participation of the woman throughout labor. Therefore, the intervention is expected to contribute not only to psychological comfort but also to improved coping ability during childbirth.

The study will be conducted using a randomized controlled trial design. Participants allocated to the intervention group will receive midwife-guided birth affirmation card support during labor, while the control group will receive standard institutional care. The intervention content is structured around themes such as adaptation to labor, relaxation, confidence, resilience, trust in the body's ability to give birth, and the promotion of a positive childbirth perception. During implementation, the midwife will provide verbal support using the cards in accordance with the clinical condition of the participant and the stage of labor.

The innovative aspect of this study lies in evaluating birth affirmation cards not merely as individual psychological tools but as a structured, midwife-led supportive care intervention. Although existing literature highlights the importance of fear of childbirth, pain perception, perceived control, and perceived support in shaping the childbirth experience, randomized controlled studies examining the combined effects of affirmation-based interventions on these outcomes remain limited. Therefore, this study is expected to contribute to evidence-based midwifery practices and support the development of woman-centered supportive care strategies in labor.

The findings of this study are anticipated to support the integration of easily applicable, cost-effective, and potentially satisfaction-enhancing supportive care practices into routine maternity care. Additionally, promoting a positive childbirth experience may contribute to improved maternal psychological well-being and enhance the visibility and professional role of midwives in intrapartum care.

Interventions

  • Other Midwife-Guided Birth Affirmation Cards
    The intervention consists of the application of structured affirmation (positive statement) cards integrated into standard midwifery care during the active phase of labor. A standardized set of 24 culturally appropriate affirmation cards, developed based on literature and expert opinion, will be used. Each participant in the intervention group will be invited to select or be guided to use a subset of these cards (e.g., 4-6 cards) according to personal preference. During uterine contractions, pa

Primary outcome measures

  • Labor Duration [Time frame: Labor/delivery durations: - Stage 1 active phase (≥4 cm to full dilation), - The duration of Stage 2 (from full dilation to the baby's birth) is given in hours and minutes.]
  • labor pains [Time frame: Pain (VAS, 0-10 cm): - Applied once at 4 cm, 6 cm, 8 cm, - Full dilation is reached, - Stage 2.]
  • Fear of Childbirth [Time frame: Fear (W-DEQ): - W-DEQ-A is administered during the early active phase (4-5 cm) - W-DEQ-B is administered within 2 hours after birth (when the mother is stable).]
  • Perception of Control and Support During Childbirth [Time frame: Sense of Control and Support (SCS): - Applied during the early active phase (4-5 cm) - within 2 hours after birth (when the mother is stable).]

Eligibility criteria

Inclusion criteria

  • Having a singleton pregnancy between 37-42 weeks of gestation
  • Being between 18-40 years of age
  • Being a primigravida
  • Having a cephalic presentation with vertex position
  • Being in the active phase of labor (cervical dilatation ≥4 cm)
  • Accepting non-invasive interventions
  • Having no mental or physical disability
  • Being able to understand and speak Turkish
  • Willingness to participate in the study

Exclusion criteria

  • High-risk pregnancies
  • Pregnant women at risk of intrapartum complications (e.g., oligohydramnios, polyhydramnios, intrauterine fetal demise, placenta previa, placental abruption, acute fetal distress, preeclampsia, fetal dystocia, macrosomia, etc.)
  • Pregnant women with a history of medical or obstetric complications
  • Women who have attended antenatal education classes (pregnancy school)
  • Women using epidural analgesia or other pharmacological pain management methods
  • Women experiencing communication difficulties
  • Women who are unwilling to participate in the study Exclusion Criteria from the Study
  • Experiencing dizziness, shortness of breath, or other discomfort,
  • Difficult and prolonged labor, instrumental delivery, placental retention, postpartum hemorrhage, need for neonatal intensive care,
  • Situations requiring emergency cesarean section during labor,
  • The woman will be excluded from the study if she ceases to cooperate during labor.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Mut Devlet Hastanesi — Mut

Identifiers

NCT: NCT07542392 · 2026/041E.132258

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗