Effect of Woman-Centered Care on Anxiety and Comfort Levels

NCT05253664 | Completed

• 1 other identifier: Woman-Cent. Care on Anx.
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety State; Condition; Physical Suffering

Keywords

Postpartum; woman-centered care; Standard care; comfort; anxiety

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Post-Test State, Trait Anxiety

  24th postpartum hour

• Post-Test postpartum Comfort Scale

  24th postpartum hour

• Systolic blood pressure

  20th postpartum hour

• Diastolic blood pressure

  20th postpartum hour

• Pulse

  20th postpartum hour

Study Arms (2)

Woman-Centered Care Group

EXPERIMENTAL

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.

Behavioral: Woman-Centered Care Group

Control Group

NO INTERVENTION

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.

Interventions

Woman-Centered Care Group BEHAVIORAL

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.

Woman-Centered Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 29219937 RESULT

• 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.

  PMID: 32320424 RESULT

• 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.

  PMID: 27297976 RESULT

• 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.

  PMID: 30094530 RESULT

• 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.

  PMID: 33537566 RESULT

• 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.

  PMID: 27757754 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Disease; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Aysegul Durmaz, Ph.D.

  Kutahya Health Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants didn't know which group they were allocated. The participants will be blind when they take Woman-Centered Care from investigators.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 24, 2022
• Study Start: February 11, 2019
• Primary Completion: August 31, 2019
• Study Completion: February 11, 2020
• Last Updated: March 5, 2025

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: If study' IPD are used, my article should be cited.

Locations

TU (1)