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临床试验/NCT06795633
NCT06795633已完成不适用

The Impact of a Holistic Care Program for High-Risk Pregnancies on Stress and Mental Health

Uskudar University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
"Perceived Stress Scale in High-Risk Pregnancies Based on the Neuman Systems Model (PSS-HRP-NSM)"

研究概览

简要总结

The aim of this study is to evaluate the effects of the Holistic Care Program for High-Risk Pregnancies on the stress levels and mental health of pregnant women. Within this framework, the study seeks to examine the potential of the holistic care program to strengthen stress coping mechanisms, positively influence mental health, and enhance general health awareness among high-risk pregnant women.

The study was conducted using a randomized controlled trial design between April 1, 2024, and December 31, 2024, at a maternity hospital in Istanbul. A total of 100 high-risk pregnant women were randomized into two groups: 50 participants were assigned to the group receiving the holistic care program along with routine midwifery care (intervention), and 50 were assigned to the group receiving only routine midwifery care (control).

The Holistic Care Program for High-Risk Pregnancies consists of three sessions: Physiological Information and Preparation for High-Risk Pregnancy, Psychological Support and Preparation, and Creative Practices and Final Evaluation.

Research data were collected using five forms: Informed Consent Form, Demographic Information Form, Perceived Stress Scale for High-Risk Pregnancies Based on Neuman Systems Model, Brief Symptom Inventory, and Holistic Care Program Evaluation Form for High-Risk Pregnancies.

详细描述

Introduction: The presence of increased health risks or complications for either the mother, the fetus, or both during pregnancy or childbirth is referred to as high-risk pregnancy. Visual and socially enriched individualized educational programs for high-risk pregnancies are emerging as an essential component of providing holistic care that addresses medical and emotional needs. These educational programs aim to reduce stress and uncertainty that pregnant women may encounter during the perinatal period by helping them better understand their health conditions and the baby's condition. It is believed that individualized education provided to high-risk pregnant women receiving care in perinatology clinics can strengthen their stress-coping mechanisms and allow them to respond more effectively to emotional needs during this period.

Objective: This study aims to evaluate the effects of a holistic care program on the stress levels and mental health of high-risk pregnant women. In this context, the study seeks to explore the program's potential to enhance stress-coping mechanisms, positively influence mental health, and increase overall health awareness among high-risk pregnant women.

Methods: The study was conducted as a randomized controlled trial in the pregnancy follow-up outpatient clinic of a maternity hospital in Istanbul between April 1, 2024, and December 31, 2024. A total of 100 pregnant women were included in the study and randomly assigned to one of two groups:

Intervention Group: 50 participants Control Group: 50 participants Data were collected at two time points: a pre-test on the first day of group assignment and a post-test on the day of discharge. Research data were gathered through face-to-face interviews using five forms: Informed Consent Form, Demographic Information Form, Perceived Stress Scale for High-Risk Pregnancies Based on Neuman Systems Model, Brief Symptom Inventory, and Holistic Care Program Evaluation Form for High-Risk Pregnancies.

The intervention group received midwifery counseling and care accompanied by the Holistic Care Program for High-Risk Pregnancies. The control group received only the standard midwifery care provided by the clinic.

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
是

入选标准

  • •Being willing to participate in the study and over the age of 18,
  • •Ability to understand and speak Turkish,
  • •Being a primiparous woman,
  • •Being in the third trimester of pregnancy.
  • •Being hospitalized in the perinatology ward and receiving care for at least 3 days
  • •Having at least one diagnosed high-risk pregnancy condition

排除标准

  • •Not willing to participate in the study
  • •Presence of a fetal anomaly
  • •Risk of fetal loss
  • •Having previously received childbirth preparation education

研究组 & 干预措施

Intervention Group

Experimental

Intervention Group Applications: High-risk pregnant women admitted to the perinatology clinic and assigned to the intervention group participated in a Holistic Care Program for High-Risk Pregnancies in addition to the midwifery care provided at the clinic.

干预措施: Holistic Care Program for High-Risk Pregnancies (Other)

Control Group

No Intervention

Control Group Applications: Routine midwifery care procedures followed in the perinatology clinic were applied to the control group.

结局指标

主要结局

"Perceived Stress Scale in High-Risk Pregnancies Based on the Neuman Systems Model (PSS-HRP-NSM)"

时间窗: At the end of the 3-day holistic care program

The scale consists of 34 items covering five life domains outlined in the Neuman Systems Model: physiological, psychological, sociocultural, developmental, and spiritual. It is a five-point Likert scale ranging from "Never (1)" to "Always (5)," with total scores ranging between 34 and 170. The sum of subscale scores reflects stress levels in the respective life domains, while the total score indicates overall stress levels. Items 22, 30, 31, 32, and 33 are reverse-coded. In the original study, the overall Cronbach's Alpha value was found to be 0.87, whereas, in this study, it was determined to be 0.954. Subscale Cronbach's Alpha values were calculated as 0.892 for the physiological domain, 0.911 for the psychological domain, and 0.867 for the sociocultural/developmental/spiritual domain. The scale was administered to both intervention and control groups as pre-test and post-test in this study, with higher scores indicating higher perceived stress levels in the respective life domains

次要结局

  • Brief Symptom Inventory (BSI)(At the end of the 3-day holistic care program)

研究者

发起方
Uskudar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuğba YILMAZ ESENCAN

Vice-dean

Uskudar University

研究点 (2)

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