Effect of Rhythm Therapy Practices on Fetal Learning, Prenatal Attachment and Prenatal Distress

NCT06665854 | Enrolling By Invitation

• 1 other identifier: SAU-SBF-BNYB-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prenatal Attachment; Prenatal Stress; Fetal Outcomes

Keywords

Prenatal Attachment; Prenatal Stress; Fetal Learning; Primiparous Pregnancy; Rhythm Therapy

Outcome Measures

Primary Outcomes (3)

• Socio-Demographic Characteristics Form

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

  27th week of pregnancy

• Prenatal Attachment Inventory

  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.

  27th week of pregnancy and 38th week of pregnancy

• Prenatal Distress Scale

  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.

  27th week of pregnancy and 38th week of pregnancy

Study Arms (3)

Rhythmic Song Group

EXPERIMENTAL

The rhythmic song group will ring a bell when starting to stimulate the baby, and will code the baby's movements as present/absent via the mobile application; then it will sing a rhythmic song and code the baby's movements as present/absent via the mobile application again.

Behavioral: Rhythmic Song Group

Rhythmic Instrument Group

EXPERIMENTAL

The Rhythmic Instrument Group will ring a bell when starting the application to stimulate the baby, and will code the baby's movements as present/absent via the mobile application; then they will play a rhythmic instrument and code the baby's movements as present/absent via the mobile application again.

Behavioral: Rhythmic Instrument Group

Control Group

PLACEBO COMPARATOR

The control group will ring a bell to warn the baby, they will code the baby's movements as present/absent via the mobile application again, and they will only rest.

Behavioral: Control Group

Interventions

Rhythmic Song Group BEHAVIORAL

The rhythmic song group will first click on the start button on the mobile application. When starting the application to stimulate the baby, a bell will ring, and the baby movements will be coded as present/absent via the mobile application; then they will sing a rhythmic song and recode the baby movements as present/absent via the mobile application. Applications will begin in the 28th week of pregnancy and continue until the 37th week of pregnancy. Pregnant women will receive rhythm therapy applications for 20 minutes twice a week.

Rhythmic Song Group

Rhythmic Instrument Group BEHAVIORAL

The Rhythmic Instrument Group will first click on the start button on the mobile application. Then, they will ring a bell to start the application to warn the baby, and they will code the baby's movements as present/absent via the mobile application; then they will play a rhythmic instrument and code the baby's movements as present/absent via the mobile application again. Applications will begin in the 28th week of pregnancy and continue until the 37th week of pregnancy. Pregnant women will receive rhythm therapy applications for 20 minutes twice a week.

Rhythmic Instrument Group

Control Group BEHAVIORAL

Control Group will first code "Start" via the mobile application. Then, a bell will ring to warn the baby, they will code the baby's 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. Applications will begin in the 28th week of pregnancy and continue until the 37th week of pregnancy. Pregnant women will receive rhythm therapy applications for 20 minutes twice a week.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, Serdivan, 54100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Bilge Nur Yıldırım Bayraktar, PhD Candidate

  Sakarya University

  STUDY DIRECTOR

• Kevser İlçioğlu, Associate professor

  Sakarya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After reaching the sample number of pregnant women for this study, pregnant women will be assigned to groups as group 1, group 2, and control group by block randomization method. This method will be used to eliminate selection bias and ensure balance between groups in terms of individuals. Random numbers table will be used in the selection of pregnant women.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: July 1, 2024
• Primary Completion: October 15, 2024
• Study Completion: November 15, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)