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Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial

Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001647820
Enrollment
343
Registered
2021-12-01
Start date
2022-03-01
Completion date
2022-04-01
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Virtual reality and music therapy reduce anxiety levels when women are taking stressfull test such as cardiac-fetal monitoring during pregancy, as well as improve some physiologycal parameters on women and their fetuses.

Interventions

Randomized clinical trial with 343 term pregnant women divided into three groups during their cardiac-fetal monitoring at the hospital: music therapy intervention group (n = 104), virtual reality (VR) intervention group (n = 124) and control group (n = 115). The cardiac-fetal monitoring will be of 20 minutes. The intervention will be carried out during the cardiac-fetal monitoring, and physiological parameters of the mother and the fetus will be collected, before and after the test. The interven

Randomized clinical trial with 343 term pregnant women divided into three groups during their cardiac-fetal monitoring at the hospital: music therapy intervention group (n = 104), virtual reality (VR) intervention group (n = 124) and control group (n = 115). The cardiac-fetal monitoring will be of 20 minutes. The intervention will be carried out during the cardiac-fetal monitoring, and physiological parameters of the mother and the fetus will be collected, before and after the test. The intervention with music therapy and virtual reality will begin with the beginning of the fetal cardiac monitoring and will end when the fetal cardiac monitoring ends. The intervention with music therapy and virtual reality will be carried out on two occasions: 1. During fetal cardiac monitoring and 2. Coinciding with the beginning of the labor dilation period. Two midwives outside the study will be in charge of performing 20-minute fetal cardiac monitoring and assisting pregnant women in the three groups during the dilation period prior to delivery. Both midwives will be in charge of ensuring compliance / fidelity of one intervention or another and of collecting the information necessary for the study. Maternal anxiety levels will also be measured through the pre-post intervention STAI test. For the musical group intervention: they will received an iPOD®-type electronic acoustic reproduction device with free and unlimited access to the Spotify Premium® music application, along with wireless headphones (Trust Urban®), with ear pads that will improved acoustics and an adjustable headband, which will allowed individual and isolated listening to the music during the process. For the VR group: they will received Bnext® 3D glasses, which will had adjustable straps to the contour of the head to give greater comfort, as well as the ability to adjust the focus and the distance that will optimize image quality and focus. For its use, it will be only necessary to insert a compatible smart mobile phone with the front part of the glasses, thus being able to see images in a 360º world. In the same way as in the musical intervention group, the patient will choose in the YouTube® electronic application the medium in which she will felt calmer and calmer, which together with the relaxing sounds that accompany the 3D images, will allowed her to disconnect when there is a fusion between listening and visualizing a situation of relaxation.

Sponsors

University of Almeria
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

- Full-term pregnant women, over 37 weeks' gestation for the performance of the CFM. - To participate voluntarily in the study. - Women whose pregnancy is low risk, meeting the criteria of being healthy women whose pregnancy has been achieved without assisted reproductive techniques or who have developed obstetric complications. - Absence of maternal exposure to drugs or medications (not prescribed by their gynecologist during pregnancy) - Nulliparous women. - Single fetus pregnancy with no known fatal fetal abnormality or known fetal cardiovascular abnormality.

Exclusion criteria

- Pregnant minors. - Pregnant women who have undergone urgent cesarean section at the end of the study. - Women who have developed gestational diabetes, pre-eclampsia / eclampsia, or other conditions that classify them as non-low-risk pregnancies during pregnancy. - Women who have given birth to a newborn (NB) weighing less than 2,200 kg or greater than 4,500 kg or the death of the fetus occurs at the end of the study. - Pregnant women in intervention group 1 and 2 who did not meet any of the study standards (stop listening to music or remove virtual reality glasses during monitoring). - Pregnant women who have presented language problems or reading and verbal comprehension difficulties.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026