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Trial registered on ANZCTR


Registration number
ACTRN12621001647820
Ethics application status
Approved
Date submitted
29/05/2021
Date registered
1/12/2021
Date last updated
18/01/2023
Date data sharing statement initially provided
1/12/2021
Date results provided
18/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Virtual Reality and Music Therapy on the Physiologic
Parameters of Pregnant Women and Fetuses and on Anxiety
Levels: A Randomized Controlled Trial
Scientific title
Effect of Virtual Reality and Music Therapy on the Physiologic
Parameters of Pregnant Women and Fetuses and on Anxiety
Levels: A Randomized Controlled Trial
Secondary ID [1] 304348 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 322118 0
Condition category
Condition code
Alternative and Complementary Medicine 319825 319825 0 0
Other alternative and complementary medicine
Mental Health 319826 319826 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320702 0
Behaviour
Intervention code [2] 321772 0
Treatment: Devices
Comparator / control treatment
For the control group: No intervention will be applied, just the cardiac-fetal monitoring during normal revision will be carried out normally, without any external intervention.
Control group
Active

Outcomes
Primary outcome [1] 327693 0
Change on pregnant women's anxiety levels during cardiac-fetal monitoring, measured by STAI test, before starting it and after finish it, on both interventional groups (music therapy and virtual reality).
Timepoint [1] 327693 0
at last routine cardiac-fetal monitoring during pregnancy after randomisation
Secondary outcome [1] 396245 0
Change on term pregnant women's blood pressure levels (measured using a sphygmomanometer) before and after interventions (music therapy and virtual reality) during the cardiac-fetal monitoring (CFM): Systolic blood pressure (SBP) and Diastolic blood pressure (DBP).
Timepoint [1] 396245 0
Assessed 5 minutes after starting the test and 5 minutes after finishing the cardiac-fetal monitoring.
Secondary outcome [2] 396246 0
Change on term pregnant women's heart rate (HR), assessed using a pulse oximeter, before and after interventions (music therapy and virtual reality) during the cardiac-fetal monitoring (CFM).
Timepoint [2] 396246 0
Assessed 5 minutes after starting the test and 5 minutes after finishing the cardiac-fetal monitoring.
Secondary outcome [3] 396247 0
Change on basal fetal heart rate (BFHR), assessed using the cardiac fetal monitoring, during the interventions (music therapy and virtual reality).
Timepoint [3] 396247 0
Assessed 5 minutes after starting the test, to assess the fetal heart rate (FHR) and 5 minutes before finishing the cardiac-fetal monitoring, to evaluate the basal fetal heart rate (BFHR) during the test.
Secondary outcome [4] 401193 0
Change in the duration of dilation time in pregnant women who have undergone music therapy or virtual reality during their last routine cardiac-fetal monitoring check and during the delivery process. It will be check by reviewing their medical history.
Timepoint [4] 401193 0
Assessed 2 months after last routine cardiac-fetal monitoring check.
Secondary outcome [5] 401194 0
Change in the beginning of labor in pregnant women who have undergone music therapy or virtual reality during their last routine cardiac-fetal monitoring check and during the delivery process. It will be check by reviewing their medical history.
Timepoint [5] 401194 0
Assessed 2 months after last routine cardiac-fetal monitoring check.
Secondary outcome [6] 401195 0
Change in the presentation of the baby in pregnant women who have undergone music therapy or virtual reality during their last routine cardiac-fetal monitoring check and during the delivery process. It will be check by reviewing their medical history.
Timepoint [6] 401195 0
Assessed 2 months after last routine cardiac-fetal monitoring check.
Secondary outcome [7] 401196 0
Change in the termination of labor in pregnant women who have undergone music therapy or virtual reality during their last routine cardiac-fetal monitoring check and during the delivery process. It will be check by reviewing their medical history.
Timepoint [7] 401196 0
Assessed 2 months after last routine cardiac-fetal monitoring check.
Secondary outcome [8] 401197 0
Change in the episiotomy/tear rate in pregnant women who have undergone music therapy or virtual reality during their last routine cardiac-fetal monitoring check and during the delivery process. It will be check by reviewing their medical history.
Timepoint [8] 401197 0
Assessed 2 months after last routine cardiac-fetal monitoring check.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2022
Actual
1/03/2022
Date of last participant enrolment
Anticipated
Actual
1/04/2022
Date of last data collection
Anticipated
Actual
1/06/2022
Sample size
Target
343
Accrual to date
Final
343
Recruitment outside Australia
Country [1] 23732 0
Spain
State/province [1] 23732 0
Almeria
Country [2] 23733 0
Spain
State/province [2] 23733 0
Murcia

Funding & Sponsors
Funding source category [1] 308719 0
University
Name [1] 308719 0
University of Almeria
Country [1] 308719 0
Spain
Primary sponsor type
University
Name
University of Almeria
Address
Universidad de Almería, Carr. Sacramento, s/n, 04120 La Cañada, Almería
Country
Spain
Secondary sponsor category [1] 309611 0
None
Name [1] 309611 0
None
Address [1] 309611 0
None
Country [1] 309611 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308578 0
University of Almeria Ethics committee
Ethics committee address [1] 308578 0
Ethics committee country [1] 308578 0
Spain
Date submitted for ethics approval [1] 308578 0
Approval date [1] 308578 0
29/03/2021
Ethics approval number [1] 308578 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111206 0
Miss Maria de Fatima Estrella Juarez
Address 111206 0
Calle Universidad de Almería, Carr. Sacramento, s/n, 04120 La Cañada, Almería
Country 111206 0
Spain
Phone 111206 0
+34 950 21 46 06
Fax 111206 0
Email 111206 0
ralarcon@ual.es
Contact person for public queries
Name 111207 0
Raquel Alarcon Rodriguez
Address 111207 0
Calle Universidad de Almería, Carr. Sacramento, s/n, 04120 La Cañada, Almería
Country 111207 0
Spain
Phone 111207 0
+34 950 21 46 06
Fax 111207 0
Email 111207 0
ralarcon@ual.es
Contact person for scientific queries
Name 111208 0
Raquel Alarcon Rodriguez
Address 111208 0
Calle Universidad de Almería, Carr. Sacramento, s/n, 04120 La Cañada, Almería
Country 111208 0
Spain
Phone 111208 0
+34 950 21 46 06
Fax 111208 0
Email 111208 0
ralarcon@ual.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.