Effect of Woman-Centered Care on Anxiety and Comfort Levels

Anxiety State Clinical Trial

Official title:

Evaluation of the Effect of Woman-Centered Care Given in the Early Postpartum Period on Anxiety and Comfort Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253664
• Other study ID #: Woman-Cent. Care on Anx.
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: February 11, 2020

Study information

• Verified date: February 2022
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: February 11, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Condition
• Pain
• Physical Suffering

Intervention

Behavioral:
• Woman-Centered Care Group
Each woman in the experimental group was given woman-centered care as from 2 hours postpartum and this process continued until 24 hours postpartum. Physiological parameters (systolic-diastolic blood pressure, pulse, body temperature) of women assigned either to the experimental group or the control group were measured at 2 hrs postpartum. The State, Trait Anxiety, and Postpartum Comfort Scales were pretested. A dynamic interaction was ensured between the researcher and the women in the experimental group who received woman-centered care. In the processes of determining and meeting the care needs of women in the early postpartum period, both the women and the researcher took equal responsibilities and the common goal of achieving safe results was shared. Clinical guidelines were used while providing woman-centered care.

Locations

Country	Name	City	State
Turkey	Kutahya Health Science University	Kütahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Ceylan B, Eser I. Assessment of individualized nursing care in hospitalized patients in a university hospital in Turkey. J Nurs Manag. 2016 Oct;24(7):954-961. doi: 10.1111/jonm.12400. Epub 2016 Jun 14. — View Citation

Durmaz A, Komurcu N. Relationship Between Maternal Characteristics and Postpartum Hemorrhage: A Meta-Analysis Study. J Nurs Res. 2018 Oct;26(5):362-372. doi: 10.1097/jnr.0000000000000245. — View Citation

Finlayson K, Crossland N, Bonet M, Downe S. What matters to women in the postnatal period: A meta-synthesis of qualitative studies. PLoS One. 2020 Apr 22;15(4):e0231415. doi: 10.1371/journal.pone.0231415. eCollection 2020. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-Test State, Trait Anxiety	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.	2nd postpartum hour
Primary	Postpartum Comfort Scale	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.	2nd postpartum hour
Primary	Systolic blood pressure	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.	2nd postpartum hour
Primary	Diastolic blood pressure	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.	2nd postpartum hour
Primary	Pulse	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.	2nd postpartum hour
Primary	Body temperature	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.	2nd postpartum hour
Secondary	Post-Test State, Trait Anxiety	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.	24th postpartum hour
Secondary	Post-Test postpartum Comfort Scale	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.	24th postpartum hour
Secondary	Systolic blood pressure	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.	20th postpartum hour
Secondary	Diastolic blood pressure	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.	20th postpartum hour
Secondary	Pulse	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.	20th postpartum hour
Secondary	Body temperature	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.	20th postpartum hour