- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06479746
Emotional Support Given at Birth to Women Effect on Birth Duration, Perception and Fear
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).
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sivas, Turkey, 58140
- Sukran Ertekin Pinar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
-Multiparity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of care Group
The control group did not receive any treatment.
|
|
|
Experimental: Emotional support group
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wijma Birth Expectation/Experience Scale (W-DEQ) Version B
Time Frame: Within 2-4 hours after birth
|
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.
|
Within 2-4 hours after birth
|
|
Women's Perceptions Scale on Supportive Care Provided at Birth
Time Frame: Within 2-4 hours after 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.
|
Within 2-4 hours after birth
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sukran Ertekin Pinar, Cumhuriyet University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TR SİVAS 05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on First Pregnancy
-
Cumhuriyet UniversityCompleted
-
University Hospital, Strasbourg, FranceUnknown
-
Technische Universität DresdenWithdrawnPregnancy Trimester, Second | Pregnancy Trimester, First | Pregnancy Trimester, ThirdGermany
-
Origin Medical Systems, Inc.CompletedFirst Trimester Pregnancy | To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant ParticipantsUnited States
-
Kocaeli UniversityRecruitingFirst PregnancyTurkey
-
Hilal ÖzbekCompleted
-
Munzur UniversityRecruitingPregnancy Related | Birth, First | Care | Care Pattern, MaternalTurkey
-
University of California, San FranciscoTerminatedFirst Trimester Pregnancy | Undesired Intrauterine PregnancyUnited States
-
Assistance Publique - Hôpitaux de ParisInstitut Pasteur; Pathogen Discovery LaboratoryRecruitingIncreased Nuchal Translucency in the First Trimester of PregnancyFrance
Clinical Trials on Emotional support
-
Taichung Veterans General HospitalUnknownPrader-Willi SyndromeTaiwan
-
Cumhuriyet UniversityCompletedEmotional Support During Cesarean DeliveryTurkey
-
Rutgers, The State University of New JerseyOrganization for Autism ResearchCompletedAutism Spectrum Disorder | Depression, AnxietyUnited States
-
Barak Cohen, MDRecruitingPostoperative DeliriumIsrael
-
VA Office of Research and DevelopmentCompletedPost Traumatic Stress DisordersUnited States
-
Rutgers, The State University of New JerseyCompletedStress, Psychological | Autism Spectrum Disorder | Psychological DistressUnited States
-
Hacettepe UniversityActive, not recruitingAdolescent Social and Emotional DevelopmentTurkey (Türkiye)
-
National University of SingaporeNot yet recruitingIntervention | Control Condition
-
Taipei Medical University Shuang Ho HospitalNot yet recruitingBurnout | Compassion Fatigue | Psychological Resilience | Occupational Stress and Mental Health in Clinical Nurses
-
Samsung Medical CenterNot yet recruitingPediatric Patients | Hospitalized Children | Pediatric Patients in Hospital SettingsSouth Korea