Clinical trial NCT05253664: Effect of Woman-Centered Care on Anxiety and Comfort Levels
Official title: Evaluation of the Effect of Woman-Centered Care Given in the Early Postpartum Period on Anxiety and Comfort Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Condition
Physical Suffering
Keywords: Postpartum
woman-centered care
Standard care
comfort
anxiety
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted as a single blind, prospective, and simple randomized controlled trial. The sample was calculated through Power analysis. 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. The size and number of blocks divided into two groups as E and C was calculated as 20 (6E and 6C) with twelve mothers in each block. Using Microsoft Office Excel 2016, numbers ranging from 1 to 20 were randomly generated. A total of 240 mothers were evenly assigned to both groups. At the time of the study, 22 women were excluded from the study. The research was completed with 218 mothers, 109 women in each of the experimental and control groups.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-Test State, Trait Anxiety
timeFrame: 2nd postpartum hour
measure: Postpartum Comfort Scale
timeFrame: 2nd postpartum hour
measure: Systolic blood pressure
timeFrame: 2nd postpartum hour
measure: Diastolic blood pressure
timeFrame: 2nd postpartum hour
measure: Pulse
timeFrame: 2nd postpartum hour
measure: Body temperature
timeFrame: 2nd postpartum hour
Secondary outcomes:
measure: Post-Test State, Trait Anxiety
timeFrame: 24th postpartum hour
measure: Post-Test postpartum Comfort Scale
timeFrame: 24th postpartum hour
measure: Systolic blood pressure
timeFrame: 20th postpartum hour
measure: Diastolic blood pressure
timeFrame: 20th postpartum hour
measure: Pulse
timeFrame: 20th postpartum hour
measure: Body temperature
timeFrame: 20th postpartum hour
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
affiliation: Kutahya Health Science University
name: Aysegul Durmaz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Verbiest S, Tully K, Simpson M, Stuebe A. Elevating mothers' voices: recommendations for improved patient-centered postpartum. J Behav Med. 2018 Oct;41(5):577-590. doi: 10.1007/s10865-018-9961-4. Epub 2018 Aug 9.
citation: Fontein-Kuipers Y, de Groot R, van Staa A. Woman-centered care 2.0: Bringing the concept into focus. Eur J Midwifery. 2018 May 30;2:5. doi: 10.18332/ejm/91492. eCollection 2018.
citation: Verbiest S, Bonzon E, Handler A. Postpartum Health and Wellness: A Call for Quality Woman-Centered Care. Matern Child Health J. 2016 Nov;20(Suppl 1):1-7. doi: 10.1007/s10995-016-2188-5.