PregnancyNCT07112495
Maternal Burnout, Breastfeeding Self-Efficacy and Attachment Level
A study testing pregnant women with in people with Pregnancy, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Labor pain causes women to be afraid of vaginal delivery and to be anxious about delivery and therefore to prefer cesarean delivery (Ali Alahmari et al., 2020). The World Health Organization (WHO) has set the safe cesarean section rate for countries at 15% (World Health Organization, 2015). Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- pregnant women with
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a normal vaginal delivery in the delivery room,
- 19 to 45 years old
- To be transferred to the Puerperium service after delivery,
- The baby's APGAR score is 7 and above
- 37 and above weeks of gestation
- No complications in the baby and mother due to childbirth
Show all 10Show fewer
- Postnatal care by the mother's side
- Mother and baby sharing the same room after birth until discharge,
- The mother is breastfeeding her baby,
- Mother's voluntary participation in the study.
Who cannot join
- Separation of mother and baby for any reason while the mother is with the baby
- Transfer of the baby to the NICU
- Wanting to get out of the study.
- Being a single parent
- Those who cannot speak and write Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Vaginal Delivery With Labor Analgesia on Maternal Burnout, Breastfeeding Self-Efficacy and Attachment Level
Labor pain causes women to be afraid of vaginal delivery and to be anxious about delivery and therefore to prefer cesarean delivery (Ali Alahmari et al., 2020). The World Health Organization (WHO) has set the safe cesarean section rate for countries at 15% (World Health Organization, 2015). However, many countries are well above this rate (Betran et al., 2021). An important factor in the preference for cesarean deliveries is the fear of vaginal delivery (Zhao et al., 2021). Vaginal delivery with epidural anesthesia in primiparous women is a very good opportunity to prevent the preference of cesarean deliveries due to fear of vaginal delivery. Unless contraindicated, epidural analgesia should be offered to women to alleviate the pain felt with contractions during labor (Callahan et al., 2023).
Recently, women frequently prefer epidural anesthesia to avoid pain during vaginal delivery. Vaginal delivery with epidural anesthesia aims to minimize the pain of women during the trauma process and is the most effective pain method among pharmacological and nonpharmacological interventions (Antonakou, \& Papoutsis, 2016). The reason why vaginal delivery with epidural anesthesia is not widespread enough is that women are not given enough information about epidural anesthesia (Shishido et al., 2020).
Read the detailed description
Purpose: The aim of this study is to emphasize the importance of vaginal birth with epidural anesthesia in primiparous women (who will have their first birth) in order to reduce the effect of fear of vaginal birth on the choice of cesarean section and to evaluate the effect of increasing the level of knowledge about epidural anesthesia on birth preferences.
Objectives:
To determine the level of fear and anxiety of women regarding childbirth.
To examine the effect of fear of vaginal birth on the preference for cesarean section.
To evaluate the effectiveness of vaginal birth with epidural anesthesia in pain management.
To determine the level of knowledge of women about epidural anesthesia.
To increase the rate of preference for vaginal birth by providing information about epidural anesthesia.
To reveal the role of widespread use of epidural anesthesia in reducing cesarean section rates.
- Conditions
- Pregnancy
- Being tested
- pregnant women with
- Keywords
- pregnancy, pain, burnout, breastfeeding
- Medical subject headings
- Pain, Burnout, Psychological, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregnant women withOther
pregnant women with
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | pregnant women receiving epidural Receives: Other: pregnant women with |
| Control | No intervention | no pregnant women receiving epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the breastfeeding self-efficacy levels of mothers.
Assessed using the Breastfeeding Self-Efficacy Scale The minimum possible score on the scale is 14, and the maximum is 70. There is no cutoff point for the scale, and a higher score indicates higher breastfeeding self-efficacy.
Measured: 1 year
To evaluate maternal attachment levels.
Measured with a validated maternal attachment scale. The lowest possible score on the scale is 26, and the highest is 104. A higher score indicates a higher level of maternal attachment.
Measured: 1 year
To examine the breastfeeding status of infants during the first six months of life.
Including exclusive breastfeeding, partial breastfeeding, and formula supplementation
Measured: 1 year
To monitor infant growth and development through percentile tracking during the first six months.
Based on weight, height, and head circumference measurements compared with growth charts
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
- Investigators
- Tiryaki, Study chair, Sakarya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112495
- Sponsor's protocol ID
- OznurT.
- Status last verified
- Dec 2025
- First submitted
- 14 May 2025
- Last updated
- 2 Jan 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Vaginal Delivery With Labor Analgesia on Maternal Burnout, Breastfeeding Self-Efficacy and Attachment Level
- ClinicalTrials.gov ID
- NCT07112495
- Acronym / sponsor ID
- OznurT.
- Conditions
- Pregnancy
- Keywords
- pregnancy, pain, burnout, breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 8 Aug 2025 (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.
Labor pain causes women to be afraid of vaginal delivery and to be anxious about delivery and therefore to prefer cesarean delivery (Ali Alahmari et al., 2020). The World Health Organization (WHO) has set the safe cesarean section rate for countries at 15% (World Health Organization, 2015). However, many countries are well above this rate (Betran et al., 2021). An important factor in the preference for cesarean deliveries is the fear of vaginal delivery (Zhao et al., 2021). Vaginal delivery with epidural anesthesia in primiparous women is a very good opportunity to prevent the preference of cesarean deliveries due to fear of vaginal delivery. Unless contraindicated, epidural analgesia should be offered to women to alleviate the pain felt with contractions during labor (Callahan et al., 2023).
Recently, women frequently prefer epidural anesthesia to avoid pain during vaginal delivery. Vaginal delivery with epidural anesthesia aims to minimize the pain of women during the trauma process and is the most effective pain method among pharmacological and nonpharmacological interventions (Antonakou, \& Papoutsis, 2016). The reason why vaginal delivery with epidural anesthesia is not widespread enough is that women are not given enough information about epidural anesthesia (Shishido et al., 2020).
Detailed description
Purpose: The aim of this study is to emphasize the importance of vaginal birth with epidural anesthesia in primiparous women (who will have their first birth) in order to reduce the effect of fear of vaginal birth on the choice of cesarean section and to evaluate the effect of increasing the level of knowledge about epidural anesthesia on birth preferences.
Objectives:
To determine the level of fear and anxiety of women regarding childbirth.
To examine the effect of fear of vaginal birth on the preference for cesarean section.
To evaluate the effectiveness of vaginal birth with epidural anesthesia in pain management.
To determine the level of knowledge of women about epidural anesthesia.
To increase the rate of preference for vaginal birth by providing information about epidural anesthesia.
To reveal the role of widespread use of epidural anesthesia in reducing cesarean section rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was designed as a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: pregnant women withpregnant women receiving epidural |
| Control | No intervention | –no pregnant women receiving epidural |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Having a normal vaginal delivery in the delivery room,
- 19 to 45 years old
- To be transferred to the Puerperium service after delivery,
- The baby's APGAR score is 7 and above
- 37 and above weeks of gestation
Key exclusion criteria (5 listed)
- Separation of mother and baby for any reason while the mother is with the baby
- Transfer of the baby to the NICU
- Wanting to get out of the study.
- Being a single parent
- Those who cannot speak and write Turkish
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 |
|---|---|---|
| pregnant women withpregnant women with | Other | intervention |
Primary outcome
To determine the breastfeeding self-efficacy levels of mothers.
Time frame: 1 year
Assessed using the Breastfeeding Self-Efficacy Scale The minimum possible score on the scale is 14, and the maximum is 70. There is no cutoff point for the scale, and a higher score indicates higher breastfeeding self-efficacy.
To evaluate maternal attachment levels.
Time frame: 1 year
Measured with a validated maternal attachment scale. The lowest possible score on the scale is 26, and the highest is 104. A higher score indicates a higher level of maternal attachment.
To examine the breastfeeding status of infants during the first six months of life.
Time frame: 1 year
Including exclusive breastfeeding, partial breastfeeding, and formula supplementation
To monitor infant growth and development through percentile tracking during the first six months.
Time frame: 1 year
Based on weight, height, and head circumference measurements compared with growth charts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- DOI: 10.14744/DAJPNS.2023.00212Link provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Tiryaki study chair
Sakarya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pregnant women with in people with Pregnancy, run by Sakarya 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the breastfeeding self-efficacy levels of mothers. (time frame: 1 year). 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 2 Jan 2026.