Effect of Woman-Centered Care on Anxiety and Comfort Levels

Not Applicable

Completed

• Conditions: Anxiety State; Physical Suffering; Condition
• Interventions: Behavioral: Woman-Centered Care Group

• Registration Number: NCT05253664
• Lead Sponsor: Kutahya Health Sciences University

Brief Summary

H1a: There is a statistically significant difference in anxiety levels between women who received woman-centered care in the early postpartum period and women who received standard care.

H1b: There is a statistical difference in terms of comfort levels between women who received woman-centered care in the early postpartum period and women who received standard care.

H0a: There is no statistically significant difference in anxiety levels between women who received woman-centered care in the early postpartum period and women who received standard care.

H0b: There is no statistical difference in terms of comfort levels between women who receive female-centered care in the early postpartum period and women who receive standard care.

Detailed Description

The research was carried out as a single-blind and block randomized control. The research was conducted in a tertiary hospital in Turkey between February, 2019 and February 2020. The universe of the research consisted of women who gave birth by cesarean section. In the power analysis, the sample size was calculated as a minimum of 105 for each group, according to α:0.05 and 1-β= 0.95. Considering the possibility of loss or separation of the selected specimens during the conduct of the study, 240 women who met the inclusion criteria were assigned to the experimental (120) and control (120) groups.Due to the nature of the study, it was conducted as a single-blind randomized controlled trial.

The pre-test procedure was performed when the mothers' statuses were stabilized two hour after the admittance to the maternity service. The post-test procedure was conducted one hour before the discharge. Woman-centered care was provided to the experimental group, and standard care was provided to the control group.The women in the experimental and control groups were not told which group they were in. Each woman in the experimental group was given woman-centered care from the 2nd hour postpartum, and this process continued until the mother was discharged (mothers are discharged after 24 hours). The standard care provided by the hospital covers the basic postpartum care components. These components are the nutrition of the newborn and the protection of maternal and newborn health. A dynamic interaction was established between the women in the experimental group and the researcher in which woman-centered care was applied. Each woman in the experimental group was responsible for explaining herself, her own health behaviors, and her own needs and values.

"Descriptive Information Form", "Postpartum Comfort Scale" and "State-Trait Anxiety Inventory" were used as data collection tools.

Statistical analyses were performed using IBM SPSS (Statistical Package for Social Sciences) Statistics 22 software. Descriptive statistics (mean, standard deviation, frequency and percentage values) were used to assess the results. Kolmogorov-Smirnov test was used to review the goodness of fit to normal distribution.

Study Timeline

• Study Start: 2019-02-11
• Primary Completion: 2019-08-31
• Study Completion: 2020-02-11
• Status Verified: 2022-02
• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-24
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 218

Inclusion Criteria

• To receive woman-centered care
• To have cesarian section
• To have singleton birth
• To be within the early postpartum period (the first 24 hours)
• Not have complications childbirth
• Not have chronic diseases or mental disorders
• Older than 18 years
• To voluntary to participate
• To know how to read, write and speak in Turkish
• To stay within this study until the end
• To fully complete questionnaire
• To have a newborn with no complications
• To have a healthy baby

Exclusion Criteria

• To receive standart care
• Not have cesarian section
• Having multiple birth
• Not to be within the early postpartum period (the first 24 hours)
• Having complications childbirth
• Having chronic diseases or mental disorders
• Younger than 18 years
• To refuse to participate
• Not knowing how to read, write and speak Turkish
• To leave early this study
• Not fill the questionnaire
• Having a newborn with complications
• Having a baby in need of medical care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Woman-Centered Care Group	Woman-Centered Care Group	Woman-centered care was given to the experimental group. At the time of the study, 6 women were discharged early, 4 women did not want to continue the study, and the babies of 1 women were admitted to the neonatal intensive care unit due to complications so these women were excluded from the study. The study was completed with 109 women in the experimental group.

Primary Outcome Measures

Name	Time	Method
Pre-Test State, Trait Anxiety	2nd postpartum hour	The State, Trait Anxiety Inventory consists of two subscales, being state and trait anxiety subscales, and 40 items. The State Anxiety Inventory determines how an individual feels at a certain moment and under certain conditions, and the Trait Anxiety Inventory on the other hand, generally determines how one feels. High scores indicate a high level of anxiety.
Systolic blood pressure	2nd postpartum hour	All of women were measured from the cubital fossa area using a digital sphygmomanometer. In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices. The first measurement of the physiological parameters of the women in both the experimental and control groups was recorded when they agreed to participate in the study. The measurement taken at the 2nd postpartum hour will be accepted. It will not be combined with the value measured at another time.
Body temperature	2nd postpartum hour	Body temperature was measured from the forehead using a non-contact thermometer. In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices. The first measurement of the physiological parameters of the women in both the experimental and control groups was recorded when they agreed to participate in the study. The measurement taken at the 2nd postpartum hour will be accepted. It will not be combined with the value measured at another time.
Pulse	2nd postpartum hour	Pulse was measured using a digital sphygmomanometer. In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices. The first measurement of the physiological parameters of the women in both the experimental and control groups was recorded when they agreed to participate in the study. The measurement taken at the 2nd postpartum hour will be accepted. It will not be combined with the value measured at another time.
Postpartum Comfort Scale	2nd postpartum hour	It is a five-point Likert-type scale that evaluates the physical, psychological, sociocultural and environmental comfort of mothers who had cesarean section and normal spontaneous delivery. The lowest and the highest scores that can be obtained from the 34-item scale are 34 and 170, respectively. High scores obtained from the scale indicate that the level of comfort increases.
Diastolic blood pressure	2nd postpartum hour	All of women were measured from the cubital fossa area using a digital sphygmomanometer. In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices. The first measurement of the physiological parameters of the women in both the experimental and control groups was recorded when they agreed to participate in the study. The measurement taken at the 2nd postpartum hour will be accepted. It will not be combined with the value measured at another time.

Secondary Outcome Measures

Name	Time	Method
Diastolic blood pressure	20th postpartum hour	All of women were measured from the cubital fossa area using a digital sphygmomanometer. In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices. The measurement taken at the 20th postpartum hour will be accepted. It will not be combined with the value measured at another time.
Post-Test State, Trait Anxiety	24th postpartum hour	The State, Trait Anxiety Inventory consists of two subscales, being state and trait anxiety subscales, and 40 items. The State Anxiety Inventory determines how an individual feels at a certain moment and under certain conditions, and the Trait Anxiety Inventory on the other hand, generally determines how one feels. High scores indicate a high level of anxiety.
Post-Test postpartum Comfort Scale	24th postpartum hour	It is a five-point Likert-type scale that evaluates the physical, psychological, sociocultural and environmental comfort of mothers who had cesarean section and normal spontaneous delivery. The lowest and the highest scores that can be obtained from the 34-item scale are 34 and 170, respectively. High scores obtained from the scale indicate that the level of comfort increases.
Systolic blood pressure	20th postpartum hour	All of women were measured from the cubital fossa area using a digital sphygmomanometer. In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices. The measurement taken at the 20th postpartum hour will be accepted. It will not be combined with the value measured at another time.
Body temperature	20th postpartum hour	Body temperature was measured from the forehead using a non-contact thermometer. In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices. The measurement taken at the 20th postpartum hour will be accepted. It will not be combined with the value measured at another time.
Pulse	20th postpartum hour	Pulse was measured using a digital sphygmomanometer. In order to ensure consistency in the measurement of physiological parameters, measurements were conducted on the women using the same devices. The measurement taken at the 20th postpartum hour will be accepted. It will not be combined with the value measured at another time.

Trial Locations

Locations (1)

Kutahya Health Science University; 🇹🇷 Kütahya, Turkey