The Effect of Music Played to Newborn Mothers on Postpartum Blues: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Postpartum blues evaluated using the Edinburgh Postpartum Depression Scale
研究概览
简要总结
The prospective and two-arm randomized controlled study was conducted on n = 82 (41 = control, 41 = music group) mothers who gave birth at term at Trakya University Health Research and Application Center Maternity Service between May and December 2023. The music group was listened to Turkish music played for 30 minutes every day for 2 postpartum days. Research data were collected through the "Personal Information Form", "Stein Blues Scale (SDS)" and Edinburgh Postpartum Depression Scale (EPDS). The scales used in the research were evaluated four times: pre-, intermediate, follow-up and post-test. Descriptive statistics, Pearson and Spearman's correlation analyzes will be used in the analysis of research data.
详细描述
Type of Research This study was conducted in a prospective, two-arm and randomized controlled manner.
Where the Research Was Conducted The research was conducted on mothers who gave birth at Trakya University Health Research and Application Center Maternity Service between May and December 2023.
Population/Sample of the Research The power analysis of the study was performed with the G*POWER 3.1.9.7 (Power analysis statistical software) program. To determine the sample size of the study, to measure the effect of music applied to mothers with term babies on postpartum blues, 41 control groups and 41 control groups were used to test a difference in the predicted medium effect size (d=.5) based on our clinical observation with a 5% margin of error and 80% power value. It was calculated that a total of 82 mothers, 41 in the intervention group, should be included in the study.
Data Collection Tools-Validity and Reliability Information In the study, "Personal Information Form", "Stein Blues Scale" and "Edinburgh Postpartum Depression Scale", which were created by the researchers by scanning the literature, were used.
Personal Information Form: Containing the personal characteristics of mothers who have just given birth (age, mother's education level, mother's employment status, family type, spouse's age, spouse's education status, spouse's employment status, income status, place of residence, smoking status, alcohol use status, 12 questions regarding physical exercise status, 10 questions about obstetric characteristics (number of pregnancies, number of live births, number of children, number of miscarriages, number of curettages, type of birth, intentional pregnancy status, planned pregnancy status, gender of the baby, week of birth of the baby), psycho-social characteristics (the state and frequency of feeling tense in daily life, the methods used to calm down when tense in daily life, the situation of using traditional and complementary methods to calm down when tense in daily life, and which method is used to calm down when tense in daily life, the traditional and complementary methods used to calm down when tense in daily life). If using complementary methods, sharing with the source of information and healthcare personnel, current emotional state, emotional state regarding pregnancy, psychological support from spouse during pregnancy, psychological support from relatives (such as mother/sibling) during pregnancy, social status during pregnancy. It consists of a total of 34 questions, 12 of which are evaluating relationships, spending time with friends during pregnancy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18-49,
- •To can read, understand and write Turkish,
- •Had a term birth (single birth at 38 weeks and above),
- •Had a normal vaginal delivery or cesarean delivery after an uncomplicated pregnancy,
- •Has stable vital signs, who is undergoing infertility treatment not having any chronic disease (such as hypertension, diabetes mellitus),
- •Do not experiencing serious depression, anxiety and stress, not having any organic or non-organic disease that may cause cognitive impairment (such as delirium, dementia, mental retardation, etc.),
- •Not having serious maternal complications,
- •Mothers who volunteered to participate in the study
排除标准
- •Under 18 and over 49 years of age,
- •Preterm birth (under 37 weeks and/or multiple birth),
- •After a complicated pregnancy, birth has not been completed by normal vaginal delivery or cesarean delivery method,
- •Without stable vital signs,
- •Those who have received infertility treatment,
- •Having a chronic disease (such as hypertension, diabetes mellitus),
- •Experiencing serious depression, anxiety and stress,
- •Having any organic or non-organic disease that may cause cognitive impairment (such as Delirium, Dementia, Mental Retardation, etc.),
- •Serious maternal complications,
- •Mothers who did not volunteer to participate in the research
结局指标
主要结局
Postpartum blues evaluated using the Edinburgh Postpartum Depression Scale
时间窗: change from baseline and 1 and 2 day of practice.
It was created by George S. Stein in 1980. Stein used this scale for the first time in a study in which 37 women were included in the first postpartum week and then followed for 3 months. The scale consists of two parts with a total of 13 questions. The first 8 questions are likert-type questions that examine mood symptoms. In the second part, the answers are yes/no; There are 5 questions investigating the presence of symptoms such as headache, restlessness, difficulty concentrating, forgetfulness and confusion. While the scoring of the section containing Likert-type questions varies between 0-4, if there is a symptom in the last 5 questions, 1 point for each is added to the total score. The minimum score is 0 while the maximum score is 26. Patients are asked to answer the scale thinking only of that day (23). While mild blues symptoms apply to scores between 3 and 8, scores of 8 and above indicate severe blues symptoms.
Depression evaluated using the Stein Blues Scale
时间窗: change from baseline and 1 and 2 day of practice.
Cox et al. (1987) to determine the risk of depression in women in the postpartum period. EPDS is used . The answers to the 4-point Likert type scale consisting of 10 questions are scored between 0-3. The cut-off score for the scale was taken as 12/13. If the score obtained is 12 and below, the patient is considered not at risk for postpartum depression, and if it is 13 and above, the patient is considered at risk for postpartum depression. Scores from the scale range from 0 to 30.
次要结局
未报告次要终点
研究者
Burcu KUCUKKAYA
Asst. Prof
Trakya University