The Effect of Lullaby Intervention on Anxiety and Prenatal Attachment in Women With High-risk Pregnancy: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Anxiety change
研究概览
简要总结
The aim of present study was to investigate the effect of lullaby intervention on anxiety and prenatal attachment in women with high-risk pregnancy. The study involved women with high-risk pregnancy who were assigned randomly to the intervention (n=30) or control (n=30) groups in a state hospital in Turkey. For two successive days, the intervention group listened to lullabies for 20 minutes once a day, meanwhile touched the abdomen and thought about their babies, but the control group did not. Data from the outcomes of anxiety and attachment were collected at baseline and at the end of the second day. Vital findings were measured on each study day, both before and after the lullaby intervention/usual care.
详细描述
Women with high-risk pregnancy may experience anxiety and low prenatal attachment due to many problems with pregnancy and hospitalization. It is reported that anxiety can have negative effects on prenatal attachment. The anxiety during pregnancy may adversely affect the health of the pregnant woman and fetus.
During the study period, 777 pregnant women were admitted to the clinic and 125 of them with high-risk pregnancy were assessed for eligibility for the study on 2 days a week. The pregnant women (n=76) who met the inclusion criteria and agreed to participate in the study were recruited. Participants were randomized in equal numbers to the intervention (n=38) and control groups (n=38) by withdrawing computer randomized sampling numbers (using Microsoft Excel 2010) from concealed envelopes to determine their group status. Participants were numbered according to their order of admittance to the hospital. After obtaining informed content and collecting baseline data, main researcher randomly chose one code for each woman. Data was collected together until the sample size was reached.
Participants were recruited by simple random sampling from the perinatology clinic at a state hospital in Turkey. An estimation of sample size was calculated at an effect size of 2.43 with a 5% level of significance on the primary outcome of anxiety in a sample study. According to G*power 3.1 31, each group required 30 participants. During the study, 125 women were assessed for eligibility, 49 of them were excluded. Some participants withdrew due to preterm birth (n=5), referral to another hospital (n=1) or discharged from hospital (n=10). Finally 60 participants who completed the lullaby intervention were included in data analysis. As a result of the study, the power of the test (α=0.05, 95% confidence interval) was 99.9% for each group n=30.
The preliminary study included five women at risk of preterm delivery who met the inclusion criteria. They were subjected to a lullaby intervention, and their study variables were evaluated. The women in the preliminary study were not included in the main study.
The IG listened to lullabies, and accompanied by lullabies touched their abdomen and thought about their babies. The CG received only the usual care of the hospital.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Hospitalization due to high-risk pregnancy
- •19 years and older
- •Pregnancy duration longer than 28 weeks.
- •Singleton pregnancy.
- •Duration of hospitalization 24 hours minimum.
- •Ability to read and write and to comprehend.
- •Speaking Turkish.
排除标准
- •Hospital admission due to severe preeclampsia, eclampsia or ablatio placenta.
- •Presence of mental or cognitive disorders.
- •Being under psychiatric treatment.
- •Vision or hearing impairments.
- •Fetal deformity or anomalies such as congenital diseases
结局指标
主要结局
Anxiety change
时间窗: At baseline and at the end of the 2nd day of study, anxiety was assessed.
As assessed by the State-Trait Anxiety Inventory (STAI) STAI consists of two scales, a total of 40 self-reported items. The State Anxiety Scale only used in this study, consists of 20 straight and inverse scored terms, and is scored between 20 and 80 in a likert type scoring between 1 and 4. High scores indicate high anxiety levels.
Prenatal attachment change
时间窗: At baseline and at the end of the 2nd day of study, prenatal attachment was assessed.
As assessed by the Prenatal Attachment Inventory (PAI) PAI which is a likert type scale, has 21-item with four scores (1-4) and the total score is 21-84. A higher scores indicate higher levels of attachment.
次要结局
- Change in Respiratory Rate(At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care)
- Change in Systolic Blood Pressure(At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care)
- Change in Heart Rate(At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care)
- Change in Diastolic Blood Pressure(At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care)
研究者
Nazlı Baltacı
Principal Investigator
Ondokuz Mayıs University
