Effects of Watson's Human Caring Theory-Based Nursing Care on Fear of Childbirth and Birth Experience

December 28, 2025 updated by: Candan Ozturk, Near East University, Turkey

Effects of Watson's Human Caring Theory-Based Nursing Care on Fear of Childbirth and Birth Experience: A Randomized Controlled Trial

The purpose of this clinical trial was to evaluate the effect of integrating a nursing care program based on Watson's Theory of Human Caring into the childbirth process on mothers' fear of childbirth and childbirth experience among women who had uncomplicated vaginal births.

The study aimed to examine whether nursing care structured according to Watson's Theory of Human Caring differed from routine nursing care in terms of fear of childbirth and childbirth experience during labor.

Researchers compared an intervention group, which received Watson's Theory-based nursing care, with a control group, which received routine nursing care, using standardized assessment tools.

Participants:

Received either nursing care based on Watson's Theory of Human Caring or routine nursing care during labor

Completed the Fear of Childbirth Scale (FOBS) and the Questionnaire for Assessing Childbirth Experience (QACE)

Were monitored and assessed throughout the labor process

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial was designed to evaluate the effect of integrating a nursing care program based on Watson's Theory of Human Caring into the childbirth process on mothers' fear of childbirth and childbirth experience.

The study was conducted at a public hospital in Northern Cyprus between May 2024 and March 2025. A total of 30 mothers who experienced uncomplicated vaginal births were enrolled and randomly assigned to either the intervention group (n = 15) or the control group (n = 15).

The control group received routine nursing care, while the intervention group received nursing care structured according to Watson's Theory of Human Caring. The study employed a single-blind design, in which participants were unaware of their group allocation.

Data were collected using the Fear of Childbirth Scale (FOBS) and the Questionnaire for Assessing the Childbirth Experience - Short Version (QACE). These instruments were used to assess fear of childbirth and childbirth experience during labor and the postpartum period.

Statistical analyses were planned to compare outcomes between the intervention and control groups and to examine the effect of theory-based nursing care on fear of childbirth and childbirth experience.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus
        • Burhan Nalbantoglu state hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women ≥18 years, at 37-41 weeks of gestation, Pregnant women in the active phase of labor (cervical dilation ≥ 3 cm). Pregnant women who presented with spontaneous labor were directed to vaginal de-livery after physician evaluation.

Pregnant women carrying a single fetus in a vertex presentation. Pregnant women with an estimated fetal weight between 2500 4000 grams. Pregnant women undergo regular uterine contractions characteristic of the active phase.

Pregnant women who are literate in Turkish.

Exclusion Criteria:

  • Pregnant women younger than 18 years. Pregnant women older than 45 years. Pregnant women with multiple pregnancies. Pregnant women with a history of in vitro fertilization (IVF). Pregnant women in the latent phase with cervical dilation < 3 cm. Pregnant women who received spinal, epidural, or general anesthesia during la-bor.

Pregnant women with a previous cesarean section (C/S). Pregnant women with a history of uterine surgery. Pregnant women whose delivery resulted in an emergency cesarean section. Pregnant women diagnosed with a mental disorder. Pregnant women showing signs of tokophobia (clinical fear of childbirth. Pregnant women who were separated from their newborn baby for medical reasons after delivery.

Pregnant women with a history of preeclampsia. Pregnant women with premature rupture of membranes (PROM). Pregnant women with placenta anomalies (placenta previa, placental abruptio, etc.).

Pregnant women with chronic diseases (DM, HT, etc.). Pregnant women with infectious diseases or active infections. Pregnant women with anemia. Pregnant women with fetal macrosomia. Pregnant women with vaginal bleeding. Pregnant women with abnormal vital signs. Pregnant women with presentation anomalies (breech, transverse)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Mothers in the intervention group received nursing care based on Watson's Human Caring Theory during labor. This care included emotional support, therapeutic communication, and individualized interventions aimed at reducing fear of childbirth and improving overall birth experience.
Behavioral: Intervention Group: Watson's Human Caring Theory-Based Nursing Care
Mothers in the intervention group received nursing care based on Watson's Human Caring Theory during labor. This care included individualized emotional support, therapeutic communication, and other nursing interventions designed to reduce fear of childbirth and enhance overall birth experience. The program was specifically tailored to each mother's needs, distinguishing it from routine nursing care provided in standard labor management.
Active Comparator: Control Group
Mothers in the control group received routine nursing care during labor. No additional interventions based on Watson's Human Caring Theory were administered.
Behavioral: Routine Nursing Care
Mothers in the control group received routine nursing care during labor. No additional interventions based on Watson's Human Caring Theory were administered. This care followed standard hospital procedures for labor and delivery, without any individualized behavioral or supportive programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birth Experience
Time Frame: 1-1.5 months postpartum
Mothers' overall childbirth experience was assessed using the validated Questionnaire for Assessing Childbirth Experience - Short Version (QACE) through telephone interviews conducted 1 to 1.5 months after delivery. Each dimension of the QACE is scored on a scale ranging from 1 to 4, with higher scores indicating more negative childbirth experiences.
1-1.5 months postpartum
Fear of Childbirth Scale
Time Frame: During the active and transition phases of the first stage of labor
The level of fear experienced by mothers during labor was assessed using the validated Fear of Childbirth Scale (FOBS). The total score of the FOBS ranges from 0 to 100, with higher scores indicating higher levels of fear of childbirth. A cut-off score of 50 was used to classify participants as having fear of childbirth.
During the active and transition phases of the first stage of labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Near East University, Turkey

Investigators

  • Principal Investigator: Candan Ozturk, Prof. Dr., Near East University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2024

Primary Completion (Actual)

March 15, 2025

Study Completion (Actual)

March 15, 2025

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YTK.1.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) from this study will not be shared. The dataset contains sensitive personal health information collected from mothers during labor, and sharing is restricted to protect participant privacy and confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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