- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05520060
The Effect of Continuous Midwifery Care at Birth on Labor Pain, Comfort and Satisfaction
Introduction: Birth is a period in which biological, physical, emotional and social changes are experienced. Supportive care provided by the midwife ensures the adaptation of the woman to labor and improves her ability to cope with labor. Supportive care has positive effects on labor and maternal and infant health.
Purpose: This project aimed to determine the birth pain, comfort and satisfaction levels by considering the continuous midwifery care at birth with a holistic approach.
Method: The universe of this study, which will be conducted in randomized controlled experimental type, will consist of pregnant women who applied to Adana City Training and Research Hospital, Gynecology and Obstetrics Clinic, Delivery Room. The number of samples was calculated by G*power analysis, and it was aimed to carry out the research with 30 participants in the intervention group and 30 participants in the control group. Single-blind randomized assignment and block randomization will be performed to avoid selection bias. Data will be collected using face-to-face interview technique. The pre-test will be applied to pregnant women who apply to the delivery room in the latent phase. While the continuous midwifery care model will be applied to the intervention group, standard midwifery care will be applied to the control group. The final test will be done between 1-4 hours postpartum. The independent variable of the study is continuous midwifery care. The dependent variable is the introductory characteristics of women, labor pain, comfort and satisfaction levels. The data will be analyzed with appropriate analysis methods after performing normality tests.
Study Overview
Status
Conditions
Detailed Description
During childbirth, women need someone's support. Providing continuous care to women with a supportive and holistic approach by midwives who care for women is seen as a potential that can improve labor pain management, birth comfort and satisfaction. The aim of this research is to determine the effect of continuous midwifery care at birth on labor pain, comfort and satisfaction levels.
For this purpose, the objectives are:
- To apply the continuous midwifery care model,
- To increase women's normal birth comfort and satisfaction,
- To create social awareness that midwives play a key role in normal birth,
- Reducing preventable maternal and infant and infant deaths due to care deficiencies,
- To reduce cesarean rates.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Adana, Turkey
- Çukurova University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate
- Knowing Turkish and being literate,
- Don't be in the latent phase.
Exclusion Criteria:
- high risk pregnancy
- Multiple pregnancy
- Breech presentation
- Induction of labor
- Emergency cesarean section indication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental
The experimental group will be placed in continuous midwifery care.
The continuous and supportive care stages to be presented at birth are planned within the framework of Kolcaba's comfort theory.
According to this theory, interventions will be applied according to the physical, psychospiritual, environmental and sociocultural comfort needs of women.
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Pharmacological and non-pharmacological methods in pain management, Mobilization, Position preferred by the woman, Fluid and nutritional support, Massage applications, Sacral pressure, Listening to music, Breathing and relaxation exercises
Other Names:
Effective communication, Encouragement to speak up and express fears, Support for faith-oriented practices
Other Names:
egulating the temperature, light and sound of the room, Environment that promotes respect for privacy, Reducing environmental noise, Information, Social support, Talking about cultural practices, Social support
Other Names:
Admission to the delivery room, preparation for birth, delivery, postpartum care, etc.
Other Names:
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Placebo Comparator: Control
The experimental group will be placed in routine midwifery care.
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Admission to the delivery room, preparation for birth, delivery, postpartum care, etc.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Birth Comfort Scale
Time Frame: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in comfort level.
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Change from birth comfort between passive phase of childbirth and active phase of childbirth.
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pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in comfort level.
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Birth Satisfaction Scale
Time Frame: immediately after the intervention/1-4 hours postpartum. An increase in the score is interpreted as an increase in satisfaction level.
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Birth satisfaction in the early postpartum period.
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immediately after the intervention/1-4 hours postpartum. An increase in the score is interpreted as an increase in satisfaction level.
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Scale of Pain Expression during Childbirth (ESVADOPA)
Time Frame: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth.An increase in the score is interpreted as an increase in the expression of pain.
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Change from pain expression level between passive phase of childbirth and active phase. of childbirth.
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pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth.An increase in the score is interpreted as an increase in the expression of pain.
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Visual Analog Scale
Time Frame: pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in pain.
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Change from pain between passive phase of childbirth and active phase of childbirth.
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pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in pain.
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Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03.06.2022/49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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