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

NCT07321457 | Completed DMC

• 1 other identifier: YTK.1.01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fear of Childbirth; Childbirth Experience

Keywords

childbirth; caring; fear; nursing

Outcome Measures

Primary Outcomes (2)

• Birth Experience

  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

  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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Intervention Group: Watson's Human Caring Theory-Based Nursing Care BEHAVIORAL

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.

Intervention Group

Routine Nursing Care BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals who are biologically female and capable of giving birth were eligible to participate. There were no restrictions based on self-identified gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Burhan Nalbantoglu state hospital

Nicosia, Cyprus

Location

Study Officials

• Candan Ozturk, Prof. Dr.

  Near East University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 7, 2026
• Study Start: July 8, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)