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临床试验/NCT07321457
NCT07321457
已完成
不适用

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

Near East University, Turkey1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月8日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Near East University, Turkey
入组人数
30
试验地点
1
主要终点
Birth Experience

概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: Intervention Group: Watson's Human Caring Theory-Based Nursing Care (Behavioral)

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.

干预措施: Routine Nursing Care (Behavioral)

结局指标

主要结局

Birth Experience

时间窗: 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.

Fear of Childbirth Scale

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Near East University, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Candan Ozturk

Co-Investigator

Near East University, Turkey

研究点 (1)

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