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The Effect of Continuous Midwifery Care at Birth on Labor Pain, Comfort and Satisfaction

Primary Purpose

Labor Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physical support
Psychospiritual support
Environmental and sociocultural support
Routine care
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring Continuous midwifery care, supportive care, Labor pain, Comfort,

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cukurova UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental

Control

Arm Description

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.

The experimental group will be placed in routine midwifery care.

Outcomes

Primary Outcome Measures

Birth Comfort Scale
Change from birth comfort between passive phase of childbirth and active phase of childbirth.
Birth Satisfaction Scale
Birth satisfaction in the early postpartum period.
Scale of Pain Expression during Childbirth (ESVADOPA)
Change from pain expression level between passive phase of childbirth and active phase. of childbirth.
Visual Analog Scale
Change from pain between passive phase of childbirth and active phase of childbirth.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2022
Last Updated
December 5, 2022
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05520060
Brief Title
The Effect of Continuous Midwifery Care at Birth on Labor Pain, Comfort and Satisfaction
Official Title
The Effect of Continuous Midwifery Care at Birth on Labor Pain, Comfort and Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Anticipated)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Continuous midwifery care, supportive care, Labor pain, Comfort,

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The experimental group will be placed in routine midwifery care.
Intervention Type
Other
Intervention Name(s)
Physical support
Other Intervention Name(s)
Supportive Care
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Psychospiritual support
Other Intervention Name(s)
Supportive Care
Intervention Description
Effective communication, Encouragement to speak up and express fears, Support for faith-oriented practices
Intervention Type
Other
Intervention Name(s)
Environmental and sociocultural support
Other Intervention Name(s)
Supportive Care
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Routine care
Other Intervention Name(s)
Health care
Intervention Description
Admission to the delivery room, preparation for birth, delivery, postpartum care, etc.
Primary Outcome Measure Information:
Title
Birth Comfort Scale
Description
Change from birth comfort between passive phase of childbirth and active phase of childbirth.
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.
Title
Birth Satisfaction Scale
Description
Birth satisfaction in the early postpartum period.
Time Frame
immediately after the intervention/1-4 hours postpartum. An increase in the score is interpreted as an increase in satisfaction level.
Title
Scale of Pain Expression during Childbirth (ESVADOPA)
Description
Change from pain expression level between passive phase of childbirth and active phase. of childbirth.
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.
Title
Visual Analog Scale
Description
Change from pain between passive phase of childbirth and active phase of childbirth.
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants are women who have given birth.
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayseren Cevik, Msc
Phone
+90 (322) 338 64 84
Email
acevik@cu.edu.tr
Facility Information:
Facility Name
Cukurova University
City
Adana
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayseren Cevik, Msc

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Continuous Midwifery Care at Birth on Labor Pain, Comfort and Satisfaction

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