search
Back to results

Effect of Woman-Centered Care on Anxiety and Comfort Levels

Primary Purpose

Anxiety State, Condition, Physical Suffering

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Woman-Centered Care Group
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety State focused on measuring Postpartum, woman-centered care, Standard care, comfort, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Kutahya Health Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Woman-Centered Care Group

Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 2, 2022
Last Updated
February 14, 2022
Sponsor
Kutahya Health Sciences University
search

1. Study Identification

Unique Protocol Identification Number
NCT05253664
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
February 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State, Condition, Physical Suffering
Keywords
Postpartum, woman-centered care, Standard care, comfort, anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Participants didn't know which group they were allocated. The participants will be blind when they take Woman-Centered Care from investigators.
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Woman-Centered Care Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Woman-Centered Care Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pre-Test State, Trait Anxiety
Description
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.
Time Frame
2nd postpartum hour
Title
Postpartum Comfort Scale
Description
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.
Time Frame
2nd postpartum hour
Title
Systolic blood pressure
Description
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.
Time Frame
2nd postpartum hour
Title
Diastolic blood pressure
Description
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.
Time Frame
2nd postpartum hour
Title
Pulse
Description
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.
Time Frame
2nd postpartum hour
Title
Body temperature
Description
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.
Time Frame
2nd postpartum hour
Secondary Outcome Measure Information:
Title
Post-Test State, Trait Anxiety
Description
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.
Time Frame
24th postpartum hour
Title
Post-Test postpartum Comfort Scale
Description
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.
Time Frame
24th postpartum hour
Title
Systolic blood pressure
Description
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.
Time Frame
20th postpartum hour
Title
Diastolic blood pressure
Description
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.
Time Frame
20th postpartum hour
Title
Pulse
Description
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.
Time Frame
20th postpartum hour
Title
Body temperature
Description
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.
Time Frame
20th postpartum hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysegul Durmaz, Ph.D.
Organizational Affiliation
Kutahya Health Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kutahya Health Science University
City
Kütahya
ZIP/Postal Code
43000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
Starting 6 months after publication
IPD Sharing Access Criteria
If study' IPD are used, my article should be cited.
Citations:
PubMed Identifier
29219937
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.
Results Reference
result
PubMed Identifier
32320424
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.
Results Reference
result
PubMed Identifier
27297976
Citation
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.
Results Reference
result
PubMed Identifier
30094530
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.
Results Reference
result
PubMed Identifier
33537566
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.
Results Reference
result
PubMed Identifier
27757754
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.
Results Reference
result

Learn more about this trial

Effect of Woman-Centered Care on Anxiety and Comfort Levels

We'll reach out to this number within 24 hrs