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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520060
• Other study ID #: 03.06.2022/49
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: December 2022
• Source: Cukurova University
• Contact: Ayseren Cevik, Msc
• Phone: +90 (322) 338 64 84
• Email: acevik[@]cu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Other:
• Physical support
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
• Psychospiritual support
Effective communication, Encouragement to speak up and express fears, Support for faith-oriented practices
• Environmental and sociocultural support
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
• Routine care
Admission to the delivery room, preparation for birth, delivery, postpartum care, etc.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth Comfort Scale	Change from birth comfort between passive phase of childbirth and active phase of childbirth.	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.
Primary	Birth Satisfaction Scale	Birth satisfaction in the early postpartum period.	immediately after the intervention/1-4 hours postpartum. An increase in the score is interpreted as an increase in satisfaction level.
Primary	Scale of Pain Expression during Childbirth (ESVADOPA)	Change from pain expression level between passive phase of childbirth and active phase. of childbirth.	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.
Primary	Visual Analog Scale	Change from pain between passive phase of childbirth and active phase of childbirth.	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.