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

NCT07542392 | Not Yet Recruiting

• 1 other identifier: 2026/041E.132258
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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?"

Conditions

Duration of Labor; Labor Pain; Fear of Childbirth; Control (Internet Only); Support

Keywords

Affirmation cards; labor pain; fear of childbirth; perceived control; perceived support; midwifery care; primigravida; non-pharmacological methods

Outcome Measures

Primary Outcomes (4)

• Labor Duration

  The researcher will monitor the duration of labor and interventions through the Birth Care Guide. The Birth Care Guide provides a structured monitoring framework aimed at conducting clinical monitoring systematically, based on evidence, and in a woman-centered manner throughout all stages of labor, from the moment the pregnant woman is admitted to the delivery unit. The guide is based on the World Health Organization's (WHO) positive birth experience and intrapartum care model, and includes the regular recording of clinical parameters related to the progress of labor (cervical dilation, uterine contractions, fetal and maternal monitoring findings), as well as principles of respectful maternal care such as continuous midwifery support, informed consent, effective communication, protection of privacy, supportive care practices, and joint decision-making.

  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

  The researcher will monitor labor pain using a VAS (Visual Analog Scale). The VAS will be used to measure the pain perceived by the individual. This scale was developed by Price et al. (1983) (Price et al., 1983). In this study, a 10 cm long Visual Analog Scale (VAS) will be used for pain assessment. The left end of the scale will be labeled '0 = no pain', and the right end will be labeled '10 = unbearable pain'.

  Pain (VAS, 0-10 cm): - Applied once at 4 cm, 6 cm, 8 cm, - Full dilation is reached, - Stage 2.

• Fear of Childbirth

  The researcher will monitor fear of childbirth using the W-DEQ A and B version. The scale consists of 33 items. Each item is a 6-point Likert scale with scores from 1 to 6, where 1 means "completely" and 6 means "not at all". The minimum possible score on the scale is 33, while the maximum score is 198. Higher scores indicate a higher level of fear of childbirth experienced by women.

  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

  The Perception of Control and Support During Childbirth Scale will be used by the researcher. It is administered to assess women's perceptions of control and support during childbirth in the postpartum period. The Perception of Control and Support During Childbirth Scale consists of 33 items in total, comprising sub-dimensions of internal control, external control, and perceived support. The scale is a five-point Likert-type scale, where 1 means "strongly disagree" and 5 means "strongly agree". The lowest possible score is 33, and the highest is 165. A higher score indicates a higher perception of support and control during childbirth.

  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).

Study Arms (2)

Midwife-Guided Birth Affirmation Cards

EXPERIMENTAL

Intervention Group: Participants will receive midwife-guided birth affirmation card support throughout labor in addition to standard care. The midwife will use structured affirmation cards containing positive, empowering statements tailored to the stage of labor and the participant's clinical condition, providing continuous verbal and emotional support.

Other: Midwife-Guided Birth Affirmation Cards

Control Group

NO INTERVENTION

Participants will receive routine institutional intrapartum care without the use of birth affirmation cards or additional structured supportive intervention.

Interventions

Midwife-Guided Birth Affirmation Cards OTHER

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, participants will be encouraged to focus on the selected affirmation statements and repeat them silently or aloud in synchronization with breathing techniques. The midwife will support the process by presenting the cards in a visible area, reading them aloud when needed, and providing verbal encouragement. The intervention will be applied in short cycles (approximately 10-15 minutes) depending on the participant's tolerance and can be repeated throughout the active phase of labor.

Midwife-Guided Birth Affirmation Cards

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Mut Devlet Hastanesi

Mut, Mersi̇n, 33600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fatma B Dr. Öğretim Üyesi

CONTACT

+904441251; fatma.bay@karatay.edu.tr

Esma G EBE

CONTACT

+905530833048; angelesma18@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician conducting data analysis will be blinded to group assignments. Participants, care providers, and investigators will not be blinded due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to the intervention group (consent cards combined with standard midwifery care) and the control group (standard midwifery care only). The intervention will be administered during the active phase of labor and participants will use affirmation cards synchronized with breathing techniques during contractions. Both groups will receive routine postnatal care and the results will be compared between the two groups.

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 21, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)