Duration of LaborNCT07542392
Effects of Midwife-guided biırth Affirmation Cards on Labor Process and Experience ın Primigravidas
A study testing Midwife-Guided Birth Affirmation Cards in people with Duration of Labor and Labor Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Duration of Labor, Labor Pain, Fear of Childbirth
- What is being tested?
- Midwife-Guided Birth Affirmation Cards
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Having no mental or physical disability
- Being able to understand and speak Turkish
- Willingness to participate in the study
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mut Devlet Hastanesi
Mut, Mersi̇n, 33600
ESMA G MIDWIFE, 2/1, +905530833048, angelesma18@hotmail.com
About this study
Official title: Effect of Midwife-Guided Birth Affirmation Cards on Labor Duration, Pain, Fear, Control and Perceived Support in Primigravidas: A Randomized Controlled Study
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?"
Read the 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.
- Being tested
- Midwife-Guided Birth Affirmation Cards
- Keywords
- Affirmation cards, labor pain, fear of childbirth, perceived control, perceived support, midwifery care, primigravida, non-pharmacological methods
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midwife-Guided Birth Affirmation CardsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start27 Mar 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duration of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542392
- Sponsor's protocol ID
- 2026/041E.132258
- Status last verified
- Mar 2026
- First submitted
- 3 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Midwife-Guided Birth Affirmation Cards on Labor Duration, Pain, Fear, Control and Perceived Support in Primigravidas: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07542392
- Acronym / sponsor ID
- 2026/041E.132258
- Keywords
- Affirmation cards, labor pain, fear of childbirth, perceived control, perceived support, midwifery care, primigravida, non-pharmacological methods
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Midwife-Guided Birth Affirmation Cards | Experimental | Other: Midwife-Guided Birth Affirmation CardsIntervention 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. |
| Control Group | No intervention | –Participants will receive routine institutional intrapartum care without the use of birth affirmation cards or additional structured supportive intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midwife-Guided Birth Affirmation CardsThe 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. | Other | Midwife-Guided Birth Affirmation Cards |
Primary outcome
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.
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 pains
Time frame: Pain (VAS, 0-10 cm): - Applied once at 4 cm, 6 cm, 8 cm, - Full dilation is reached, - Stage 2.
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'.
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).
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midwife-Guided Birth Affirmation Cards in people with Duration of Labor and Labor Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma B Dr. Öğretim Üyesi (+904441251 ext. 7767, fatma.bay@karatay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.