The Effect of Virtual Reality Glass Use on Fetal Health Anxiety, Prenatal Distress, and Maternal-Fetal Attachment in Women With Premature Rupture of Membranes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Comparison of mean Prenatal Distress Scale scores among groups of pregnant women.
研究概览
简要总结
The Effect of Virtual Reality Glass Use on Fetal Health Anxiety, Prenatal Distress, and Maternal-Fetal Attachment in Women with Premature Rupture of Membranes: A Randomized Controlled Trial
详细描述
This study is a randomized controlled trial. The study population will consist of nulliparous pregnant women hospitalized with a diagnosis of preterm premature rupture of membranes (PPROM) in the Perinatology Clinic of Konya City Hospital between June 2025 and January 2027. A total of 176 pregnant women who will be giving birth for the first time will be included in the study (intervention group: n = 88; control group: n = 88). In the intervention group, pregnant women with PPROM will watch a nature-themed video accompanied by natural sounds selected by the researchers through a virtual reality headset (VRH) twice daily for three consecutive days, with each session lasting at least five minutes. The control group will receive the standard antenatal care provided by the hospital. Data will be collected using a Personal Information Form, the Fetal Health Anxiety Scale, the Prenatal Distress Questionnaire, and the Prenatal Attachment Inventory.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being 18 years of age or older
- •Being nulliparous
- •Having a diagnosis of preterm premature rupture of membranes (PPROM)
- •Being between 24 and 37 weeks of gestation
- •Having a singleton pregnancy
- •Being hospitalized in the ward for at least 3 days
- •Having no visual or hearing impairment
- •Being communicative and mentally and psychologically healthy
- •Being able to speak and express oneself in Turkish
排除标准
- •Having an additional diagnosis besides preterm premature rupture of membranes (PPROM) (e.g., preeclampsia, fetal distress, fetal anomalies, gestational diabetes, bleeding, etc.)
- •Having a chronic disease (e.g., hypertension, diabetes mellitus, thyroid disorders, etc.)
- •Having conceived through assisted reproductive technologies (ART)
- •Having any skin infection.
研究组 & 干预措施
Standard prenatal care
The control group will receive standard prenatal care and treatment provided by the hospital.
After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish.
干预措施: Nature-themed video (Other)
Nature-themed video
Pregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days.
干预措施: Nature-themed video (Other)
Standard prenatal care
The control group will receive standard prenatal care and treatment provided by the hospital.
After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish.
干预措施: Standard prenatal care (Other)
结局指标
主要结局
Comparison of mean Prenatal Distress Scale scores among groups of pregnant women.
时间窗: 6 months
The Prenatal Distress Scale will be administered to all pregnant women. The Prenatal Distress Scale ranges from 0 to 34 points (minimum-maximum), with higher scores indicating greater prenatal distress.
Comparison of mean Prenatal Attachment Inventory scores among groups of pregnant women.
时间窗: 6 months
The Prenatal Attachment Inventory will be administered to all pregnant women. The Prenatal Attachment Inventory score ranges from 21 to 84 points (minimum-maximum), with higher scores indicating greater prenatal distress.
Comparison of sociodemographic characteristics of pregnant women with premature rupture of membranes prior to intervention using questionnaires.
时间窗: 6 months
Sociodemographic information of pregnant women will be collected, compared, and reported through questionnaires.
Comparison of mean scores on the Fetal Health Concern Scale among groups of pregnant women.
时间窗: 6 months
The Fetal Health Concern Scale will be administered to pregnant women. The Fetal Health Concern Scale ranges from 0 to 42 points (minimum-maximum), with higher scores indicating greater fetal health concern.
次要结局
未报告次要终点
研究者
Seyhan Çankaya
Assoc. Prof. Seyhan Çankaya
Selcuk University