The Effect of Mindfulness Based Structured Nursing Interventions on Mental Health Parameters of High Risk Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Anxiety was assessed using the State-Trait Anxiety Scale
研究概览
简要总结
This randomized controlled study evaluate the effect of mindfulness-based structured nursing interventions on the mental health parameters of risky pregnant women. The hypothesis of this study is that mindfulness-based structured nursing interventions has an effect of the state-trait anxiety, perceived stress, depression on high risk pregnant women.
详细描述
Methods: This study, was carried out in three phases. In the first phase, the views and experiences of high-risk pregnant women about being treated in the hospital and in the third phase, their views and experiences about the intervention were determined through individual in-depth interviews.In the second phase, 40 high risk pregnant women were randomly assigned to the study and control groups. The study group (n = 19) received 8 days of mindfulness-based structured nursing interventions. The control group (n = 21) did not receive any intervention. Results were collected through data collection forms before the mindfulness-based structured nursing interventions, after the mindfulness-based structured nursing interventions is completed.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-65
- •Able to read and understand Turkish
- •Written informed consent was obtained before participation in the study
- •Diagnosed with a risky pregnancy and treated in hospital
- •Not receiving any other psychological therapy
- •No prior meditation experience
- •The participants do not have any physical/mental disability or limitation and disease that would prevent them from participating in the program
排除标准
- •Under 18 years old
- •Cant read and understand Turkish
- •Pregnant women who have not been diagnosed a risky pregnancy or treated in hospital
- •Meditation or psychological therapy experiences before the study
- •The participants who left the program voluntarily or participating in less than 70% of the eight-day program
研究组 & 干预措施
Experimental Group
The intervention group participated in a mindfulness-based structured nursing interventions program planned for a total of eight days, 60 minutes each day, led by Elçin Alaçam, who has a Mindfulness Institute-approved certificate. The mindfulness-based structured nursing interventions program was structured for 8 days, taking into account the literature and the characteristics of high-risk pregnant women such as length of hospitalization.
干预措施: Mindfulness Based Structured Nursing Interventions (Other)
Control Group
No intervention was applied to the control group. Data were collected from the control group simultaneously with the study group.
结局指标
主要结局
Anxiety was assessed using the State-Trait Anxiety Scale
时间窗: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
The total score obtained from both scales varies between 20 and 80. It states that 0-19 points mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Depression was assessed using the Edinburgh Postnatal Despression Scale
时间窗: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
Each item is scored 0-3 with a maximum total score of 30. Higher scores indicate a greater severity of symptoms. The most commonly-used cut-offs are ≥ 10 to indicate minor depression and ≥ 13 to indicate major depression.
Stress was assessed using the Perceived Stress Scale
时间窗: Change from before intervention up to after intervention, on average 1 week upon completion of the intervention.
Total scores range from 0 to 40, with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, from 14-26 moderate stress, and from 27-40 high perceived stress.
次要结局
- Semi-structured Individual In-Depth Interview Questionnaire II(After the intervention, on average 1 week upon completion of the intervention.)
- Semi-structured Individual In-Depth Interview Questionnaire I(Before the intervention, on average 1 week upon completion of the intervention.)
研究者
Elcin Alacam
MSc, Nurse, Principal Investigator
Mersin Training and Research Hospital