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临床试验/NCT06665854
NCT06665854Enrolling By Invitation不适用

Effect of Rhythm Therapy on Fetal Learning, Prenatal Attachment and Prenatal Distress in Pregnant Women

Sakarya University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
90
试验地点
2
主要终点
Socio-Demographic Characteristics Form

研究概览

简要总结

The concept of prenatal attachment defines the relationship between the pregnant woman and the foetus. The attachment established between the mother and the baby is an important factor in the quality of care and survival of the baby in the postnatal period, and the quality of the interaction established with the mother is also a determinant of the cognitive and social development of the baby. One of the factors affecting prenatal attachment is the stress factor. Stress also affects foetal life and has negative consequences in many life stages including neonatal period, childhood and adulthood. Another factor affecting prenatal attachment is foetal learning, which is defined as the process of intrauterine memory development. Within the scope of this study, rhythm therapy and music applications based on rhythm applications and mother's voice will be used. The effects of rhythm therapy during pregnancy on fetal learning, prenatal stress, prenatal attachment and neonatal outcomes will be examined in this study. In addition, within the scope of the study, a mobile application will be developed and installed on the phones of pregnant women and the processes related to fetal learning will be monitored online through this application. The study was planned as a randomised controlled study. All pregnant women who agree to participate in the study will first be administered the descriptive characteristics form, prenatal attachment and prenatal stress scales. Then, online trainings about the topics included in the study will be given and a mobile application will be installed on their phones. Pregnant women will be divided into 3 groups; pregnant women in the 1st group will be taught rhythmic song writing, pregnant women in the 2nd group will be taught to play rhythmic instruments and the 3rd group will be determined as the control group. The women will apply rhythmic music applications to the foetus for 20 minutes every 2 days for 2 days every week until the birth and will make coding through the mobile application installed on their phones. The response of the fetus to the music applications will be evaluated through fetal movements. At 37 weeks of gestation, prenatal attachment and prenatal stress scales will be applied and the effect of music applications will be evaluated. In this way, the effects of music practices applied in the fetal period on fetal memory, prenatal attachment and prenatal stress will be evaluated at the same time. A study of this type has not yet been found in the domestic and foreign literature. In addition, the use of mobile application within the scope of the study will contribute to the literature on mobile health applications.

详细描述

The proposed project has been transferred as 2 main Work Packages (WP). WP 1. Shooting of training videos. WP 2. Investigation of the effect of rhythm therapy application in pregnant women on prenatal attachment, prenatal stress and fetal learning.

Mobile application: A mobile application specific to the project has been developed for use by the project manager. There are 5 interfaces in this mobile application. The first interface contains the login information of the pregnant women (name-surname-gestational week-email address). Pregnant women will register to the application through this interface and their gestational age will be monitored. In this way, the manager will track the gestational week in which the applications made by the participants were made during the data collection phase of the project. The second interface contains the Socio-Demographic Characteristics Form, Prenatal Attachment Inventory and Prenatal Stress Scale to be filled out by pregnant women within the scope of the project. Pregnant women will fill out these forms at the latest at the 27th week of pregnancy before starting data collection. The third interface contains the training videos to be used in the research. Participants will complete the training videos at the latest by the 27th week of pregnancy before starting the data collection phase. The fourth interface contains the pregnancy period coding section. With the coding section in this interface, participants will code the fetal movements during rhythm therapy applications. The fifth intermediary includes the Prenatal Attachment Inventory and Prenatal Stress Scale to be filled out at the 37th week of pregnancy. Each interface is designed to be conditional on each other. Participants will follow the steps in each interface in order.

There are two main purposes for using this mobile application in this project. The first purpose is to use it during the pregnancy data collection phase of the project. Within the scope of this project, participants will be able to easily enter data through the mobile application while performing rhythm therapy applications. Thanks to the main screen loaded onto the manager's computer, it will be possible to track when rhythm therapy and music applications are performed and whether there are any baby movements after the application, thanks to the coding. In addition, thanks to the mobile application, pregnant women and postpartum mothers will be able to easily participate in the study in their own environment without coming to the hospital. This is a cost-effective method and provides opportunities for both the manager and the participants in terms of time management. The researcher will be able to follow the study data through the interface on his/her computer.

Work Package 1. Shooting of training videos: Two groups of videos will be shot within the scope of the project. The first group of videos will be on rhythm therapy. Within the scope of the project, pregnant and postpartum women are expected to write rhythmic songs/lullabies and play rhythmic instruments. The project manager has received Theoretical 3 (Distance Education) / Practical 1 (Distance Education) - Total: 4 weeks training from the Republic of Turkey Rhythm Therapy Music and Rhythm Therapy Education-Research and Application Center and has earned the right to receive a Rhythm Therapist Certificate. In addition, he/she has completed the 40-hour Music Therapy and Awareness Raising Training conducted by the Sakarya University of Applied Sciences Lifelong Education Application and Research Center and has earned the right to receive a certificate. Training videos on rhythm therapy will be shot by the project manager for the participants and will be shared with the participants who volunteer to participate in the project via the mobile application before data collection. There will be 2 videos in the first group. The subject of the first video has been determined as Music and Rhythm Therapy, and the subject of the second video has been determined as Writing rhythmic songs/lullabies and playing rhythmic instruments (metal xylophone). All videos will be shot by the facilitator at Sakarya Education and Research Hospital. The second group of videos will be videos specific to the application. Sample videos will be shot to provide information and reference to the participants during the pregnancy data collection phase of the project. 3 groups will be formed during the data collection phase of this project. These videos will include applications specific to the groups. Group 1 is the Rhythmic Song Group, Group 2 is the Rhythmic Instrument Group and Group 3 is the Control Group. During the data collection phase of the study, each group will apply the intervention specific to their group. Pregnant women will not have a need to urinate at the time of the application, they will be full and they will prefer a quiet and calm room for the application. No physical stimulation will be given to the abdomen during the application and a resting position will be taken. All pregnant women will code "Start" via the mobile application when starting. Pregnant women in the first group (rhythmic song group) will ring a bell to stimulate the baby and code the baby movements as present/absent via the mobile application; then they will sing a rhythmic song and code the baby movements as present/absent via the mobile application again. The second group of pregnant women (Rhythmic Instrument Group) will ring a bell to stimulate the baby, code the baby movements as present/absent via the mobile application; then play a rhythmic instrument and code the baby movements as present/absent via the mobile application again. The third group (control group) will ring a bell to stimulate the baby, code the baby movements as present/absent via the mobile application again and will only rest. When the application is over, all pregnant women will code "Finish" via the mobile application. A reference video will be shot to ensure that all these application patterns are more permanent in the minds of the pregnant women. The video pattern will be prepared by the facilitator and the shots will be made so that the intervention steps are clearly visible. These videos will be specific to each group and will be integrated into the mobile application and easily accessible.

Work Package 2. Investigation of the effects of rhythm therapy applications on prenatal attachment, prenatal stress and fetal learning in pregnant women:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Accepting to participate in the study, Knowing Turkish, Being a primiparous pregnancy, Not being a high-risk pregnancy, Being a singleton pregnancy, Being between 20 and 27 weeks of gestation.

排除标准

  • Not performing rhythm therapy applications twice a week, Not coding during rhythm therapy applications, Leaving the study, Giving birth before the expected date.

结局指标

主要结局

Socio-Demographic Characteristics Form

时间窗: 27th week of pregnancy

It was created by the researchers and contains 18 questions covering the socio-demographic characteristics of the participants.

Prenatal Attachment Inventory

时间窗: 27th week of pregnancy and 38th week of pregnancy

It is a 21-item inventory developed by Mary Muller (1993) to explain the thoughts, feelings, and situations experienced by women during pregnancy and to determine the level of attachment to the baby in the prenatal period. It was adapted to Turkish in Turkey in 2010 and the Cronbach alpha reliability coefficient was found to be 0.84. It has been suggested that the Prenatal Attachment Inventory is a valid and reliable tool for pregnant women in our country and that it can be used by researchers in studies to determine the level of attachment of pregnant women with different characteristics to their babies in the prenatal period.

Prenatal Distress Scale

时间窗: 27th week of pregnancy and 38th week of pregnancy

It was first developed in 1999 to assess specific concerns and anxieties specific to pregnancy, such as medical problems, physical symptoms, parenting, relationships, physical changes, birth, and the baby's health. It was adapted to Turkish in 2011, and the Cronbach alpha internal consistency coefficient was found to be 0.85. It was determined that the Turkish form of the Prenatal Distress Scale is an understandable, valid, and reliable tool for use on Turkish pregnant women in the assessment of stress that may occur during pregnancy in our country.

次要结局

未报告次要终点

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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