First PregnancyNCT06479746
Emotional Support Given at Birth to Women Effect on Birth Duration, Perception and Fear
A study testing Emotional support in people with First Pregnancy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. 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
- First Pregnancy
- What is being tested?
- Emotional support
- 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 Jul 2020to 30 Dec 2020
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous,
- Between the ages of 18-35,
- Admitted to the delivery room for normal spontaneous vaginal birth,
- Do not have any physical health problems for themselves or their baby,
- Does not have a diagnosed mental illness,
- Not having a risky pregnancy,
Show all 9Show fewer
- Able to speak and read Turkish,
- Cervical dilatation of 4 cm or more,
- Women who were willing to participate in the study were included in the study.
Who cannot join
- -Multiparity
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear.
Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).
Read the detailed description
Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.Minimizing the fears experienced during birth can lead to more successful and comfortable births, a complication-free birth and less pain for both the woman and the baby.Therefore, emotional support from healthcare professionals is important.
Aim: The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear.
Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).While emotional support practices and standard care were applied to women in the experimental group, only standard care practices were applied to women in the control group. Data were collected using the Personal Information Form, Wijma Birth Expectation/Experience Scale (W-DEQ) Version A, Wijma Birth Expectation/Experience Scale (W-DEQ) Version B, and Women's Perceptions of Supportive Care Provided at Birth Scale.The forms were applied twice to women applying for birth: during labor (first follow-up) and the second follow-up within 2-4 hours after birth. Number and percentage distribution, chi-square test, t test in independent groups, Mann-Whitney U test, Wilcoxon test, and Cohen d test were used in the evaluation of the data.
- Conditions
- First Pregnancy
- Being tested
- Emotional support
- Keywords
- Birth, Emotional support, Birth perception, Fear of birth, Birth duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional supportBehavioural
Also called Control Group
Emotional support helps the woman giving birth effectively, meets her emotional needs and expectations, ensures her comfort, improves birth outcomes, increases her self-esteem, ensures a positive birth experience and facilitates her transition into the role of motherhood.
| Study group | Role | What they receive |
|---|---|---|
| Emotional support group | Experimental | Empathetic approach, listening to the feelings and thoughts, welcoming the woman's behavior and expressions, telling her that she is breathing correctly, etc.), not judging the woman, being honest, using a soft and calm tone of voice, taking the baby or asking her opinion, encouraging her to endure the birth process, touching the woman and making physical contact, allowing her to practice her beliefs, showing the baby to the mother as soon as it is born and placing it in her arms. Receives: Behavioral: Emotional support |
| Standard of care Group | No intervention | The control group did not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
The W-DEQ-A is a validated, to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165.
Measured: Baseline
Women's Perceptions Scale on Supportive Care Provided at Birth
The scale, which consists of 33 items, has three sub-dimensions: "comforting, informing and disturbing behaviors". Answers in the scale are numbered from 1 to 4 and are in a four-point Likert type. The minimum score that can be obtained from the scale is 33, and the maximum score is 132.
Measured: Baseline
Secondary outcomes (2)
Wijma Birth Expectation/Experience Scale (W-DEQ) Version B
W-DEQ-B was developed to evaluate women's fear of birth during their own birth experiences in the postpartum period. Responses on the scale are numbered from 1 to 6 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 33 and the maximum score is 198.
Measured: Within 2-4 hours after birth
Women's Perceptions Scale on Supportive Care Provided at Birth
The scale, which consists of 33 items, has three sub-dimensions: "comforting, informing and disturbing behaviors". Answers in the scale are numbered from 1 to 4 and are in a four-point Likert type. The minimum score that can be obtained from the scale is 33, and the maximum score is 132.
Measured: Within 2-4 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 posted28 Jun 2024
- Study start1 Jul 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First PregnancyStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukran Ertekin Pinar, Cumhuriyet University
- Investigators
- Sukran Ertekin Pinar, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479746
- Sponsor's protocol ID
- TR SİVAS 05
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Support Given at Birth to Women Effect on Birth Duration, Perception and Fear
- ClinicalTrials.gov ID
- NCT06479746
- Acronym / sponsor ID
- TR SİVAS 05
- Conditions
- First Pregnancy
- Keywords
- Birth, Emotional support, Birth perception, Fear of birth, Birth duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 28 Jun 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.
Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear.
Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).
Detailed description
Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.Minimizing the fears experienced during birth can lead to more successful and comfortable births, a complication-free birth and less pain for both the woman and the baby.Therefore, emotional support from healthcare professionals is important.
Aim: The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear.
Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).While emotional support practices and standard care were applied to women in the experimental group, only standard care practices were applied to women in the control group. Data were collected using the Personal Information Form, Wijma Birth Expectation/Experience Scale (W-DEQ) Version A, Wijma Birth Expectation/Experience Scale (W-DEQ) Version B, and Women's Perceptions of Supportive Care Provided at Birth Scale.The forms were applied twice to women applying for birth: during labor (first follow-up) and the second follow-up within 2-4 hours after birth. Number and percentage distribution, chi-square test, t test in independent groups, Mann-Whitney U test, Wilcoxon test, and Cohen d test were used in the evaluation of the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional support group | Experimental | Behavioral: Emotional supportEmpathetic approach, listening to the feelings and thoughts, welcoming the woman's behavior and expressions, telling her that she is breathing correctly, etc.), not judging the woman, being honest, using a soft and calm tone of voice, taking the baby or asking her opinion, encouraging her to endure the birth process, touching the woman and making physical contact, allowing her to practice her beliefs, showing the baby to the mother as soon as it is born and placing it in her arms. |
| Standard of care Group | No intervention | –The control group did not receive any treatment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Nulliparous,
- Between the ages of 18-35,
- Admitted to the delivery room for normal spontaneous vaginal birth,
- Do not have any physical health problems for themselves or their baby,
- Does not have a diagnosed mental illness,
Key exclusion criteria (1 listed)
- -Multiparity
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 |
|---|---|---|
| Emotional supportAlso: Control GroupEmotional support helps the woman giving birth effectively, meets her emotional needs and expectations, ensures her comfort, improves birth outcomes, increases her self-esteem, ensures a positive birth experience and facilitates her transition into the role of motherhood. | Behavioural | Emotional support group |
Primary outcome
Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)
Time frame: Baseline
The W-DEQ-A is a validated, to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165.
Women's Perceptions Scale on Supportive Care Provided at Birth
Time frame: Baseline
The scale, which consists of 33 items, has three sub-dimensions: "comforting, informing and disturbing behaviors". Answers in the scale are numbered from 1 to 4 and are in a four-point Likert type. The minimum score that can be obtained from the scale is 33, and the maximum score is 132.
2 secondary outcomes
Wijma Birth Expectation/Experience Scale (W-DEQ) Version B
Time frame: Within 2-4 hours after birth
Women's Perceptions Scale on Supportive Care Provided at Birth
Time frame: Within 2-4 hours after birth
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 28 Jun 2024.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Sukran Ertekin Pinar principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional support in people with First Pregnancy, run by Cumhuriyet 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 1 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 28 Jun 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?
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?
Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A) (time frame: Baseline). The study lists 2 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 28 Jun 2024.