Effect of Woman-Centered Care on Anxiety and Comfort Levels

Kutahya Health Sciences University

Status: Completed

Conditions: Physical Suffering; Condition; Anxiety State

Treatments: Behavioral: Woman-Centered Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05253664

Woman-Cent. Care on Anx.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 2 patient groups

Woman-Centered Care Group

Experimental group

Description:

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.

Treatment:

Behavioral: Woman-Centered Care Group

Control Group

No Intervention group

Description:

Standard care was given to the control group. At the time of the study, 2 women were discharged early, 7 women did not want to continue the study, and the babies of 2 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 218 mothers, with 109 women in the control group.