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Childbirth Fear, Anxiety,Birth PainAnxietybirthNCT04478604

Anxieties Related to Childbirth and Postpartum Period

An observational study of Childbirth Fear, Anxiety,Birth Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study aimed to evaluate the relation of labor pain with anxiety and worries about labor and postpartum period in pregnant women in their last trimester. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Childbirth Fear, Anxiety,Birth Pain
What is being tested?
applied forms to pregnant women
How many people
104 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2014to 30 Dec 2014
Phase
Observational
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 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Last trimester pregnant women with have no major complications

Who may be able to join

  • Having no major complication related to pregnancy
  • Being last trimester
  • Ability to read and write in Turkish,
  • Volunteering to participate in the study
  • Planning give birth in the same hospital

Who cannot join

  • Unable to read or write in Turkish
  • Being in the last trimester
  • Changing the hospital for giving birth.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Meltem Uğurlu

    Ankara, 06018

Other trials in Turkey (Türkiye)

About this study

Official title: The Evaluation of Anxiety and Anxieties Related to Childbirth and Postpartum Period With Childbirth Pain in Last Trimester Pregnant Women

The present study aimed to evaluate the relation of labor pain with anxiety and worries about labor and postpartum period in pregnant women in their last trimester.

Read the detailed description

During pregnancy and after childbirth, women experience many physical, emotional and psychological changes and try to cope with them1. Many women have fear of childbirth and anxiety for various reasons such as uncertainties about labor, labor pain, loss of control and giving birth alone 2,3. Several studies have shown that 12%-31% of the pregnant women experience fear of childbirth 4-6. The sources of worries are usually the possible risk of harm to women themselves or their babies and attitudes and insufficient knowledge of health staff2,6-8. These prenatal worries may lead to pain and restlessness during labor, emergency cesarean section and postpartum affective disorders 1.

Stress experienced during pregnancy affects not only maternal health but also childbirth outcomes (e.g. preterm labor and low birth weight) 9. Anxiety most frequently experienced in the first and last trimesters are not directly associated with obstetric complications; however, it may cause obstetric complications due to the changes it created in the endocrine system1,7,9. Although labor pain can be due to physiological changes such as cervix dilatation and uterus contractions, it may result from psychological factors like stress, anxiety and fear 10. In several studies, the relation between state and trait anxiety scores just before or during childbirth and pain experienced during labor has been evaluated 11,12.

According to the World Health Organization (WHO), the purpose of the antenatal care is to help women to have a positive childbirth experience 13. Positive expectations about childbirth during pregnancy may lead to a positive childbirth experience, while anxiety, fear or negative expectations can create a negative childbirth experience 14. Several studies have shown that antenatal education decreases anxiety and labor pain 15,16.

It is of importance to reveal worries and anxiety experienced by pregnant women during and after childbirth and to evaluate their relationship with labor pain in terms of provision of higher-quality antenatal care and development of more effective coping strategies to deal with these problems. Thereby, women may be more healthy during their pregnancy and have a positive childbirth experience.

This study aimed to determine the relation of labor pain with worries about childbirth and the postpartum period and state-trait anxiety levels in pregnant women in the last trimester.

MATERIAL AND METHODS The study has a descriptive, prospective design and was conducted in the obstetric clinic of a research and education hospital between January and November in 2014. The study population included the pregnant women in their third trimester presenting to the obstetrics outpatient clinic of the hospital at the time of the study and the sample comprised 115 pregnant women planning to give birth in the same hospital. Since five women did not volunteer to participate in the study and since six women gave birth in another hospital, the study was performed with 104 women (90%).

Data collection tools Data were gathered with a sociodemographic and obstetric features questionnaire created by the researchers in light of the literature, 1,11,17 Fear of Childbirth and Postpartum Anxiety Scale (FCPAS), Spielberger State and Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS).

Sociodemographic and Obstetric Features Questionnaire The questionnaire was composed of two sections. The first section involved questions about sociodemographic features including age, employment status and education. The second section involved 11 questions about the total number of pregnancies, outcome of the prior pregnancy, experiencing problems during the prior pregnancy, experiencing problems in the current pregnancy and planned mode of childbirth.

Fear of Childbirth and Postpartum Anxiety Scale FCPAS was developed by Kitapçıoğlu et al. in 2007 to determine worries experienced during and after childbirth 1. The scale is composed of ten subscales and 61 items. It is a five-point Likert scale and one corresponds to completely disagree and five totally agree. Some items are scored in the reverse order. The scores for the scale range from zero to ten. The scores 0.00-2.00 are very low, the scores 2.01-4.00 are low, the scores 4.01-6.00 are moderate, the scores 6.01-8.00 are high and the scores 8.01-10.00 are very high18. Cronbach's alpha was reported to 0.95 for the original scale1 and it was found to be 0.96 in the present study.

Spielberger State and Trait Anxiety Inventory STAI was developed by Spielberg et al. in 1970 to measure state and trait anxiety levels of individuals. It was adapted to the Turkish culture by Öner and LeCompte in 198519,20. The inventory is composed of two scales; i.e. state anxiety scale (STAI-State) and trait anxiety scale (STAI-Trait), and each involves 20 items. The former is directed towards determining how individuals feel at a certain moment and under a certain condition, whereas the latter shows how individuals feel in general. STAI is a four-point Likert scale. The total score for the inventory changes between 20 and 80. The scores 0-19 show lack of anxiety, the scores 20-39 mild anxiety, the scores 40-59 moderate anxiety, the scores 60-79 severe anxiety and the score 80 and over 80 very severe anxiety 20.

Visual Analogue Scale VAS was developed by Price et al. in 1983 to measure the severity of pain 21. It is frequently used to determine the severity of pain experienced by women during labor 3,11. Individuals are asked to assign a score for their pain on a 10cm-scale ranging from zero to ten. Zero corresponds to lack of pain and ten corresponds to very severe pain.

Data Collection The women were given information about the aim and methods of the study and their participation in the study had a voluntary basis. Those accepting to participate in the study and planning to give birth in the hospital where this study was conducted were given the data collection tools and requested to complete them by the researcher . It took 15 minutes for each participant to fill them in. The researcher answered the questions asked by the participants during the data collection process. The participants were given the researcher's phone number and asked to call when they came to hospital to give birth. In addition, every day during the study period, the researchers checked whether there were any participants among the women presenting to the hospital to give birth. The pain severity was evaluated by using VAS in the women giving normal birth in the delivery room during the active phase of labor and in the women having cesarean section in the postpartum four hours.

Ethical considerations Ethical approval was obtained from the ethical committee (date of approval: 16.12.2013) and written permission was obtained from the hospital where the study was performed. Written consent was taken from the participants after they were informed about the aim and conduction of the study. The study was carried out in accordance with the Declaration of Helsinki .

Data Analysis Obtained data were analyzed with the SPSS for Windows 16.0 (IBM Corporation Armonk, New York, USA). Kolmogorov Smirnov test was used to determine whether the data about continuous variables were normally distributed. Numbers, percentages, median and mean ±standard deviation were used for descriptive statistics. Cronbach's alpha coefficient was determined. For comparative statistics, t test, one-way analysis of variance, Kruskal Wallis test and Mann Whitney U test were utilized. The relation between two continuous variables was analyzed with Spearman correlation test. The statistical significance was set at 0.05 for all the analyses.

Being tested
applied forms to pregnant women
Keywords
Pregnancy, Childbirth, Postpartum period, Nursing care
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • applied forms to pregnant womenOther

    Also called Sociodemographic and Obstetric Features Questionnaire,Fear of Childbirth and Postpartum Anxiety Scale,Spielberger State and Trait Anxiety Inventory

Study groups in NCT04478604
Study groupRoleWhat they receive
pregnant womenlast trimester pregnant women and gave birth in the same hospital
Receives: Other: applied forms to pregnant women

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fear of Childbirth and Postpartum Anxiety Scale

    The questionnaire was composed of two sections. The first section involved questions about sociodemographic features including age, employment status and education. The second section involved 11 questions about the total number of pregnancies, outcome of the prior pregnancy, experiencing problems during the prior pregnancy, experiencing problems in the current pregnancy and planned mode of childbirth.

    Measured: in the third trimester of pregnancy (between the 28-40 gestational week)

Secondary outcomes (2)
  1. Spielberger State and Trait Anxiety Inventory

    STAI was developed by Spielberg et al. in 1970 to measure state and trait anxiety levels of individuals. It was adapted to the Turkish culture by Öner and LeCompte in 198519,20. The inventory is composed of two scales; i.e. state anxiety scale (STAI-State) and trait anxiety scale (STAI-Trait), and each involves 20 items. The former is directed towards determining how individuals feel at a certain moment and under a certain condition, whereas the latter shows how individuals feel in general. STAI is a four-point Likert scale. The total score for the inventory changes between 20 and 80. The scores 0-19 show lack of anxiety, the scores 20-39 mild anxiety, the scores 40-59 moderate anxiety, the scores 60-79 severe anxiety and the score 80 and over 80 very severe anxiety 20.

    Measured: in the third trimester of pregnancy (between the 28-40 gestational week)

  2. Visual Analogue Scale

    VAS was developed by Price et al. in 1983 to measure the severity of pain 21. It is frequently used to determine the severity of pain experienced by women during labor 3,11. Individuals are asked to assign a score for their pain on a 10cm-scale ranging from zero to ten. Zero corresponds to lack of pain and ten corresponds to very severe pain.

    Measured: in the active phase of labor and within the first 4 hours after cesarean delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start15 Jan 2014
  3. Primary completion15 Nov 2014
  4. Study completion30 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04478604
Sponsor's protocol ID
SBUuniversitesi
Acronym
Anxietybirth
Status last verified
May 2022
First submitted
16 Jul 2020
Last updated
10 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Curzik D, Jokic-Begic N. Anxiety sensitivity and anxiety as correlates of expected, experienced and recalled labor pain. J Psychosom Obstet Gynaecol. 2011 Dec;32(4):198-203. doi: 10.3109/0167482X.2011.626093. Epub 2011 Oct 31.

    PubMed 22039971
  • Tugut N, Tirkes D, Demirel G. Preparedness of pregnant women for childbirth and the postpartum period: their knowledge and fear. J Obstet Gynaecol. 2015 May;35(4):336-40. doi: 10.3109/01443615.2014.960375. Epub 2014 Sep 29.

    PubMed 25265338
  • Laursen M, Hedegaard M, Johansen C; Danish National Birth Cohort. Fear of childbirth: predictors and temporal changes among nulliparous women in the Danish National Birth Cohort. BJOG. 2008 Feb;115(3):354-60. doi: 10.1111/j.1471-0528.2007.01583.x.

    PubMed 18190372
  • Hildingsson I, Nilsson C, Karlstrom A, Lundgren I. A longitudinal survey of childbirth-related fear and associated factors. J Obstet Gynecol Neonatal Nurs. 2011 Sep-Oct;40(5):532-43. doi: 10.1111/j.1552-6909.2011.01274.x.

    PubMed 22273410

Questions about this trial

What is this clinical trial studying?

An observational study of Childbirth Fear, Anxiety,Birth Pain, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 5 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: finished, as of the sponsor's last update on 10 May 2022. 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?

Fear of Childbirth and Postpartum Anxiety Scale (time frame: in the third trimester of pregnancy (between the 28-40 gestational week)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04478604, which also lists 4 linked publications.

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 10 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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