Effectiveness of Pregnancy Guidance and Support Program (PreG-SupP) on quality of life, stress, and anxiety among pregnant women who received infertility treatment in a selected hospital of Kannur district, Kerala- a Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- - Primary outcome of the study will be Improved quality of life Reduced stress and Reduced anxiety
研究概览
简要总结
Infertility impacts a significant portion of the population at some stage in their lives. The existing literature gave insight into the need for assessment of mental health of pregnant women following infertility treatment. Only limited studies have focused on quality of life among the pregnant women following infertility treatment. There are studies done among pregnant women who conceived spontaneously. The existing literature revealed that the pregnant women following infertility treatment are more stressed, anxious about pregnancy, and the health of their baby and they require extra support during their pregnancy. The purpose of this study is to evaluate how effective is the Pregnancy Guidance and Support Program (PreG-SupP) in improving the quality of life and reducing stress and anxiety of pregnant women who conceived through IVF and to have better maternal and neonatal outcomes. The study also aimed to empower mothers about antenatal care, how to manage the difficulties encountered due to physical and physiological changes during pregnancy and how to prepare better for childbirth.
HYPOTHESES
All the hypotheses will be tested at 0.05 level of significance.
H1: There will be significant difference in the quality-of-life scores among pregnant women who received infertility treatment between the intervention and control group.
H2: There will be significant difference in the stress scores among pregnant women who received infertility treatment between the intervention and control group.
H3: There will be significant difference in the anxiety scores among pregnant women who received infertility treatment between the intervention and control group.
H4: There will be significant difference in the social support scores among pregnant women who received infertility treatment between the intervention and control group.
H5: There will be significant difference in the pregnancy and neonatal outcomes among pregnant women who received infertility treatment between the intervention and control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 24.00 Year(s) 至 44.00 Year(s)（—）
- 性别
- Female
入选标准
- •24-33 years: 6 blocks with block size 10 (5 each in intervention & control arm) (n=60) 33-44 years: 6 blocks with block size 10 (5 each in intervention & control arm) (n=60) -with a period of gestation 8 – 10 weeks, having confirmed pregnancy with cardiac activity after the primary infertility treatment with In Vitro Fertilization visiting the Reshmi Infertility Clinic, a unit of Koyili Hospital, Kannur District, Kerala.
- •Who will come for regular follow-up in the Reshmi Infertility Clinic, Kannur -Who are willing to participate in the study and give consent.
- •Know to read and speak Malayalam or English.
排除标准
- •Pregnant women with severe chronic medical conditions like pre-existing cardiovascular respiratory or renal diseases blood disorders multiple pregnancies history of psychiatric illness Who have undergone structured psychological intervention over the past 6 months or more than 5 sessions.
结局指标
主要结局
- Primary outcome of the study will be Improved quality of life Reduced stress and Reduced anxiety
时间窗: Follow up at 16, 24, 32 weeks of gestation, at 36 weeks of gestation and at the time of delivery delivery.
次要结局
- • Secondary outcomes include successful pregnancy and neonatal outcome, good social support, increased knowledge and good acceptance of the Pregnancy Guidance and Support Program.(Follow up at 16, 24, 32 weeks of gestation, at 36 weeks of gestation and after delivery)
研究者
Shelmi Antony
Koyili College of Nursing Kannur;Manipal College of Nursing Manipal