PregnantNCT06754111
The Effect of Ideal Birth Environment on Birth Pain, Fear of Childbirth, Mode of Delivery and Duration of Delivery
A study testing ideal birth environment in people with Pregnant and Fear of Childbirth, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate whether the ideal birth environment is related to fear of childbirth, labor pain, duration of labor, and mode of delivery. on the impact of the study. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant, Fear of Childbirth, Ideal Birth Environment
- What is being tested?
- ideal birth environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 1 Jul 2025
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old pregnant primiparous literate
Who cannot join
- Medium and high-risk pregnant women (oligohydramnios, pre-eclampsia, heart disease, diabetes, placenta previa)
- Psychiatric illness such as anxiety and depression
- Communication barrier
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
Mehmet Akif Ersoy Üniversitesi
Burdur, Bucak, 15300
About this study
The aim of this study was to investigate whether the ideal birth environment is related to fear of childbirth, labor pain, duration of labor, and mode of delivery.
on the impact of the study. The main questions it aims to answer are Does the ideal birth environment reduce fear of childbirth? Does the ideal birth environment reduce labor pain? does the ideal birth environment affect the duration of labor? In order to evaluate the effect of the ideal birth environment on fear, pain and duration of labor, the researchers will compare the standard delivery room and women who will give birth in a room customized for women, where they have their own sheets, pillows, items that make them feel special, where medical devices are reduced, in a room where they have photos with their partner, in a room where they listen to the music they want, where they have freedom of movement. both in the experimental and control groups: In the last trimester, the Wijma birth experience A version will be applied and in the postpartum period, the Wijma B Birth experience scale will be applied again and the fear of childbirth will be evaluated. Pain in labor will also be assessed using VAS (Visceral Visual Analgesic Scale) during the latent and active phase of labor.
Read the detailed description
The birth environment filled with medical instruments increases the level of anxiety and fear in the mother.
increase, disrupting the neurohormonal relationship that ensures the normal functioning of labor and an increase in the rate of cesarean section deliveries. Also women when she does not feel safe in her environment and her baby does not feel safe, the birth process is temporary. may slow down as a result release of adrenaline (epinephrine) and noradrenaline (norepinephrine) as a result of stress and anxiety increases, creating a "fight or flight" situation in the woman. Adrenaline and noradrenaline are the main
towards the end of labor to help the fetus to expel, while towards the end of labor should be at a low level at the beginning. The woman cannot fight stress in these cases, adrenaline and noradrenaline levels increase, while oxytocin levels decrease. This one from a physiological point of view, it can cause the progression of labor to stop, the duration prolonged labor and increased cesarean section rates. In a study conducted with pregnant rats, noise and movement in the birth environment restriction has been found to negatively affect hormones involved in labor
- Conditions
- Pregnant, Fear of Childbirth, Ideal Birth Environment
- Being tested
- ideal birth environment
- Keywords
- labor pain, ideal birth environment, fear of childbirth
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ideal birth environmentBehavioural
ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice.
There will be a companion, a birthing ball and chair, and the room will allow freedom of movement.
It will be designed to allow
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | will receive standard care, no intervention will be performed |
| ideal birth environment | Active comparator | ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice.
There will be a companion, a birthing ball and chair, and the room will allow freedom of movement.
It will be designed to allow Receives: Behavioral: ideal birth environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Birth Expectancy/Expectation Questionnaire (W-DEQ) A Version
Wijma Birth Expectancy/Expectation Scale A Version (W-DEQ A), W-DEQ consists of 33 items and is a six-point Likert-type scale.
Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all".
is expressed. The minimum score 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.
is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced.
is high.
- W-DEQ score? 37 mild,
- W-DEQ score = 38-65 moderate,
- W-DEQ score = 66-84 in severe degree,
- A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement.
The alpha value of the scale is calculated by inverting the scale in the opposite direction. Cronbach's alpha value of the scale 0.89 (Korukcu et al., 2012) Wijma Birth Anticipation/Experience Sc
Measured: 28-36 weeks of gestation
VASA Pain Assessment Scale
Quantitative pain rating scale (QPRS) is used to assess the severity of pain. is used. On a numerical rating scale, pain ranges from 0 (no pain) to 10 (unbearable pain) score (Price et al., 1983).
Measured: during the latent phase of labor when the cervical opening is 1-3 cm and during the active phase of labor when the cervical opening is 5-7 cm
WIJMA BIRTH EXPECTANCY/EXPERIENCE SCALE B VERSION
he W-DEQ consists of 33 items and is a six-point Likert-type questionnaire. Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all".
is expressed. The minimum score 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.
is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced.
is high.
- W-DEQ score? 37 mild,
- W-DEQ score = 38-65 moderate,
- W-DEQ score = 66-84 in severe degree,
- A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement. is calculated by inverting it in the opposite direction in order to provide
Translated with www.DeepL.com/Translator (free version)
Measured: up to the first 12 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Oct 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnantStudies 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Göçmez, Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754111
- Sponsor's protocol ID
- GO 2024/510
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 31 Dec 2024
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ideal Birth Environment on Birth Pain, Fear of Childbirth, Mode of Delivery and Duration of Delivery
- ClinicalTrials.gov ID
- NCT06754111
- Acronym / sponsor ID
- GO 2024/510
- Conditions
- Pregnant, Fear of Childbirth, Ideal Birth Environment
- Keywords
- labor pain, ideal birth environment, fear of childbirth
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 31 Dec 2024 (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 was to investigate whether the ideal birth environment is related to fear of childbirth, labor pain, duration of labor, and mode of delivery.
on the impact of the study. The main questions it aims to answer are Does the ideal birth environment reduce fear of childbirth? Does the ideal birth environment reduce labor pain? does the ideal birth environment affect the duration of labor? In order to evaluate the effect of the ideal birth environment on fear, pain and duration of labor, the researchers will compare the standard delivery room and women who will give birth in a room customized for women, where they have their own sheets, pillows, items that make them feel special, where medical devices are reduced, in a room where they have photos with their partner, in a room where they listen to the music they want, where they have freedom of movement. both in the experimental and control groups: In the last trimester, the Wijma birth experience A version will be applied and in the postpartum period, the Wijma B Birth experience scale will be applied again and the fear of childbirth will be evaluated. Pain in labor will also be assessed using VAS (Visceral Visual Analgesic Scale) during the latent and active phase of labor.
Detailed description
The birth environment filled with medical instruments increases the level of anxiety and fear in the mother.
increase, disrupting the neurohormonal relationship that ensures the normal functioning of labor and an increase in the rate of cesarean section deliveries. Also women when she does not feel safe in her environment and her baby does not feel safe, the birth process is temporary. may slow down as a result release of adrenaline (epinephrine) and noradrenaline (norepinephrine) as a result of stress and anxiety increases, creating a "fight or flight" situation in the woman. Adrenaline and noradrenaline are the main
towards the end of labor to help the fetus to expel, while towards the end of labor should be at a low level at the beginning. The woman cannot fight stress in these cases, adrenaline and noradrenaline levels increase, while oxytocin levels decrease. This one from a physiological point of view, it can cause the progression of labor to stop, the duration prolonged labor and increased cesarean section rates. In a study conducted with pregnant rats, noise and movement in the birth environment restriction has been found to negatively affect hormones involved in labor
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –will receive standard care, no intervention will be performed |
| ideal birth environment | Active comparator | Behavioral: ideal birth environmentideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice. There will be a companion, a birthing ball and chair, and the room will allow freedom of movement. It will be designed to allow |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-35 years old pregnant primiparous literate
Key exclusion criteria (3 listed)
- Medium and high-risk pregnant women (oligohydramnios, pre-eclampsia, heart disease, diabetes, placenta previa)
- Psychiatric illness such as anxiety and depression
- Communication barrier
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 |
|---|---|---|
| ideal birth environmentideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice. There will be a companion, a birthing ball and chair, and the room will allow freedom of movement. It will be designed to allow | Behavioural | ideal birth environment |
Primary outcome
Wijma Birth Expectancy/Expectation Questionnaire (W-DEQ) A Version
Time frame: 28-36 weeks of gestation
Wijma Birth Expectancy/Expectation Scale A Version (W-DEQ A), W-DEQ consists of 33 items and is a six-point Likert-type scale. Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all". is expressed. The minimum score 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. is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced. is high. * W-DEQ score? 37 mild, * W-DEQ score = 38-65 moderate, * W-DEQ score = 66-84 in severe degree, * A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement. The alpha value of the scale is calculated by inverting the scale in the opposite direction. Cronbach's alpha value of the scale 0.89 (Korukcu et al., 2012) Wijma Birth Anticipation/Experience Sc
VASA Pain Assessment Scale
Time frame: during the latent phase of labor when the cervical opening is 1-3 cm and during the active phase of labor when the cervical opening is 5-7 cm
Quantitative pain rating scale (QPRS) is used to assess the severity of pain. is used. On a numerical rating scale, pain ranges from 0 (no pain) to 10 (unbearable pain) score (Price et al., 1983).
WIJMA BIRTH EXPECTANCY/EXPERIENCE SCALE B VERSION
Time frame: up to the first 12 hours after birth
he W-DEQ consists of 33 items and is a six-point Likert-type questionnaire. Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all". is expressed. The minimum score 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. is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced. is high. * W-DEQ score? 37 mild, * W-DEQ score = 38-65 moderate, * W-DEQ score = 66-84 in severe degree, * A W-DEQ score of ? 85 indicates a clinical degree of fear. Scale 2, Questions 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are negatively loaded and there is no agreement in the measurement. is calculated by inverting it in the opposite direction in order to provide Translated with www.DeepL.com/Translator (free version)
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 31 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ideal birth environment in people with Pregnant and Fear of Childbirth, run by Mehmet Akif Ersoy 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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 31 Dec 2024. 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?
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?
Wijma Birth Expectancy/Expectation Questionnaire (W-DEQ) A Version (time frame: 28-36 weeks of gestation). The study lists 3 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 31 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.