Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000442505
Ethics application status
Approved
Date submitted
22/02/2024
Date registered
10/04/2024
Date last updated
4/08/2024
Date data sharing statement initially provided
10/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of Foetal Auditory Abilities - Effects on Foetal Heart Rate
Scientific title
Investigation of Foetal Auditory Abilities to Perceive music - Effects on Foetal Heart Rate
Secondary ID [1] 311481 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
auditory perception 332802 0
pregnancy 332803 0
Condition category
Condition code
Reproductive Health and Childbirth 329523 329523 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research project will investigate foetal auditory abilities to perceive and process music in two separate study sets that measure foetal heart rate (studies 1a & 1b, described here) or foetal brain activity (studies 2a & 2b, described separately).
All studies will take place at Waikato Hospital and every participant will only take part in one of the study sets. Both study sets have two experiments which are separated by a five minute break in between to minimise carry over effects of foetal responses between the experiments. One of the experiments investigates musical timbre perception by using audio files of three different instruments (clarinet, trumpet, violin) while the other experiment investigates foetal harmony perception using audio files of major and minor chords that are played by a piano. For studies 1a and 1b, the stimuli are presented in 30 sec long sound blocks that are separated by 30 sec long silence blocks.
The presentation of the stimuli is controlled by a computer program written for the studies that ensures randomisation of all stimuli and counterbalancing across participants. The stimuli are delivered via a loudspeaker (Marshall Acton III Bluetooth Speaker) that is placed above the maternal abdomen.
The total time of auditory stimulation will be 15 minutes for the heart rate studies which includes short periods of silence in between each individual stimulus in every experiment.

Experimental conditions
Study 1a - musical timbre
timbres: clarinet, trumpet, violin (audio files)
trials: 18 trials per timbre with 3.492 sec sound (tone: C4 = 261.63 Hz) and 1.508 sec silence (5 sec per trial)
sound pressure level: 95 dB

Study 1b - chords
chords: C-, G-, and D-major & a-, e-, and d-minor, all played by a piano (audio files)
trials: ten trials per individual chord (= 30 per category) with 1.327 sec sound (chord) and 1.673 sec silence (3 sec per trial)
sound pressure level: 95 dB


An individual study session for the heart rate studies will be between 47-59 min long and includes the following:
One member of the research team will greet the mother-to-be and her whaanau or friends at the meeting point in front of the hospital and will bring her to the sonography unit where the experiments will take place. They will then be taken through the participant information sheet and informed consent form. The participant information sheet includes an explanation of the purpose of the studies, explains the safety of the stimuli and methods used, has a brief description of the experimental procedure, and informs about what will be done to ensure the anonymity and the safety of the collected data. All explanations will be done in a clear, easy to understand language, and every participant will be asked for questions or concerns. Afterwards, the mothers-to-be will be asked to sign two copies of the informed consent sheet of which one of them will be given to the participant to keep for her records and one of them will be kept by the researchers.
After written informed consent, the participant will be brought to the sonography room where every member of the research team present will be introduced and her or his role in the session will be explained. Next, the woman will lie down in a comfortable position on her back and routine foetal check-ups will be performed by a qualified and registered diagnostic medical sonographer with a current annual practicing certificate from the New Zealand Medical Radiation Technologists Board in Wellington. These check-ups will include measurements of the foetal bi-parietal diameter, head circumference, abdominal circumference, and femur length to estimate foetal weight and gestational age (GA). Furthermore, foetal heart rate (HR) as well as single deepest pocket of amniotic fluid will be recorded.
The experimental procedure will then be explained in more detail and exemplary stimuli will be played to give the mothers-to-be an idea of what their babies will hear during the experiments. Each participant will be explicitly asked if she has any questions or concerns, and each will be reminded that the procedure can be stopped in case she feels uncomfortable or wants to withdraw. Neither of them must be justified. Then, the mother-to-be will be asked if she agrees to proceed with the procedure. If she does, she will be reminded to remain silent during the experiments and to lie as still as possible to ensure a high quality of the collected data throughout the experimental parts. Next, the research team will identify foetal position as well as foetal behavioural state (after Nijhuis et al., 1982) using 2D-ultrasound.
The cardiotocograph (Huntleigh Sonicaid Team3) and the loudspeaker will be set-up afterwards for the HR studies and the participant and her whaanau or friends will be given headphones before the experiments start.
After the completion of both experiments, the mothers-to-be will be asked if they have heard any of the stimuli or if they felt any foetal movement during the session. Everyone will be thanked for participating, debriefed, and given the opportunity to ask further questions or to comment about the studies. Every participant will be given $ 30 vouchers in recognition of travel costs and to show appreciation of taking part in the studies as well as a debrief form that summarises the studies in easy to understand language. The debrief form also includes the contact details of the primary investigators and two recommendations for further reading if the mothers-to-be have any further interest in pregnancy, foetal, and early development in general.


References
Araki, R., & Nashimoto, I. (1992). Near-infrared imaging in vivo (II): 2-dimensional visualization of tissue oxygenation state. In T. K. Goldstick, M. McCabe & D. J. Maguire (Eds.), Oxygen Transport to Tissue XIII (pp. 173-178). Springer. https://doi.org/10.1007/978-1-4615-3404-4_20
Nijhuis, J. G., Prechtl, H. F. R., Martin, C. B., & Bots, R. S. G. M. (1982). Are there behavioural states in the human fetus?. Early Human Development, 6(2), 177-195. https://doi.org/10.1016/0378-3782(82)90106-2
Intervention code [1] 327934 0
Diagnosis / Prognosis
Comparator / control treatment
The three different timbres (clarinet, trumpet, violin) as well as the different chords (major vs. minor) will be compared to each other. The timbre and chord category that is played first will serve as the comparator. The order of the stimuli and of the two experiments is counterbalanced across participants and controlled by a computer program.
Furthermore, the foetal responses during the experimental blocks will be contrasted to blocks without auditory stimulation and complete silence. These blocks are the two baseline periods of the experiments which are two minutes each.
Control group
Active

Outcomes
Primary outcome [1] 337319 0
foetal heart rate
Timepoint [1] 337319 0
Foetal heart rate will be continuously measured during the 47-59 min long experimental session. This includes 9 min during the timbre and 6 min during the chord experiment as well as 2 min each for the two baseline periods and a 5 min break in between the experiments.
Secondary outcome [1] 431438 0
foetal movement
Timepoint [1] 431438 0
The 2D-ultrasound will be continuously used from the routine foetal check-ups at the beginning (approx. 5-10 min), during the baseline periods of both experiments (2 min each), the experiments themselves (15 min), and the break in between them (5 min). In sum, the 2D-ultrasound will be used for approximately 29-34 min in the heart rate studies.
Secondary outcome [2] 431439 0
maternal heart rate
Timepoint [2] 431439 0
Maternal heart rate will be continuously measured during the baseline periods of both heart rate experiments (2 min each), the experiments themselves (timbres: 9 min, chords: 6 min), and the break in between them (5 min). In sum, maternal heart rate will be measured for approximately 24 min.

Eligibility
Key inclusion criteria
All participants will be volunteers which will be selected based on the following inclusion criteria:
• maternal age: 18-42 years old
• singleton pregnancy
• gestational age is between 35 weeks + 0 days – 36 weeks +6 days
• no pregnancy complications
• healthy mother and healthy foetus
• age-appropriate foetal development: abdominal circumference above the 5th
percentile, estimated foetal weight greater than or equal to 10th percentile, and single
deepest pocket greater than or equal to 2 cm (Ministry of
Health, 2019)
• foetal HR is within the normal range: 120-160 bpm (Von Steinburg et al., 2013)


References
Ministry of Health. (2019, December 13). New Zealand Obstetric Ultrasound Guidelines. https://www.health.govt.nz/system/files/documents/publications/new-zealand-obstetric-ultrasound-guidelines-2019-dec19.pdf)
Von Steinburg, S. P., Boulesteix, A. L., Lederer, C., Grunow, S., Schiermeier, S., Hatzmann, W., Schneider, K. T., & Daumer, M. (2013). What is the “normal” fetal heart rate? PeerJ, 1:e82. https://doi.org/10.7717/peerj.82
Minimum age
18 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be excluded if they meet one or more of the following exclusion criteria:
• multifetal pregnancy
• gestational age is < 35 weeks or >37 weeks
• pregnancy complications which affect foetal HR, auditory, neuronal, or general foetal
development
• maternal health issues which put either the mother-to-be or the foetus at risk or which
affect foetal cardiac, auditory, neuronal, or its general development
• foetal abnormalities or health issues which affect foetal HR, auditory, neuronal, or its
general development (e. g. Down syndrome)
• the foetus is small for gestational age: abdominal circumference < 5th percentile,
estimated foetal weight < 10th percentile, and single deepest pocket < 2 cm (Ministry
of Health, 2019)
• the foetal HR is not within the normal range: <120/ >160 bpm (Von Steinburg et al.,
2013)


References
Ministry of Health. (2019, December 13). New Zealand Obstetric Ultrasound Guidelines. https://www.health.govt.nz/system/files/documents/publications/new-zealand-obstetric-ultrasound-guidelines-2019-dec19.pdf)
Von Steinburg, S. P., Boulesteix, A. L., Lederer, C., Grunow, S., Schiermeier, S., Hatzmann, W., Schneider, K. T., & Daumer, M. (2013). What is the “normal” fetal heart rate? PeerJ, 1:e82. https://doi.org/10.7717/peerj.82

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As there have not been any previous studies investigating the perception and discrimination of musical timbres and chords in the foetus, there were no previous effect sizes for the estimation of sample size. Therefore, to maximize the probability to find an effect, a conservative, small within factor effect of f = .1 was chosen. Based on a probability of 1 – ß = .95, an a-value of a = .05 and a theoretical correlation of Rho = .50 between repeated measurements, a priori calculation using G.Power 3.1.3 (Faul et al., 2009) yielded in a sample size of N = 84 for 18 trials per condition for the HR timbre experiment (study 1a). Using the same psychometric input values (f = .1, 1 – ß = .95, a = .05, and Rho = .50), a sample size of N = 60 was calculated for the HR chord experiment (study 2b) which includes 30 trials per chord category (major vs. minor). Given an attrition rate of approximately 20 % in foetal HR studies (e. g. Lecanuet et al., 1992; Lecanuet et al., 2000) data of 101 participants will be collected for the HR studies.
Please note that the final estimated sample size for both set of studies was oriented on the estimations for the experiment where a larger number of participants was needed to find a small effect of f = .1 which was the timbre experiment.

References
Faul, F., Erdfelder, E., Buchner, A., & Lang, A. G. (2009). Statistical power analyses using G* Power 3.1: Tests for correlation and regression analyses. Behavior Research Methods, 41(4), 1149-1160. https://doi.org/10.3758/BRM.41.4.1149
Lecanuet, J. P., Granier-Deferre, C., Jacquet, A. Y., & Busnel, M. C. (1992). Decelerative cardiac responsiveness to acoustical stimulation in the near term fetus. Quarterly Journal of Experimental Psychology: Section B, 44(3-4), 279-303.
Lecanuet, J. P., Graniere-Deferre, C., Jacquet, A. Y., & DeCasper, A. J. (2000). Fetal discrimination of low-pitched musical notes. Developmental Psychobiology: The Journal of the International Society for Developmental Psychobiology, 36(1), 29-39. https://doi.org/10.1002/(SICI)1098-2302(200001)36:1<29::AID-DEV4>3.0.CO;2-J
Lloyd-Fox, S., Blasi, A., & Elwell, C. E. (2010). Illuminating the developing brain: The past, present and future of functional near infrared spectroscopy. Neuroscience & Biobehavioral Reviews, 34(3), 269-284. https://doi.org/10.1016/j.neubiorev.2009.07.008

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/08/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
101
Accrual to date
0
Final
Recruitment outside Australia
Country [1] 26137 0
New Zealand
State/province [1] 26137 0
Waikato

Funding & Sponsors
Funding source category [1] 315769 0
University
Name [1] 315769 0
University of Waikato
Country [1] 315769 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Country
New Zealand
Secondary sponsor category [1] 317892 0
None
Name [1] 317892 0
Address [1] 317892 0
Country [1] 317892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314627 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 314627 0
Ethics committee country [1] 314627 0
New Zealand
Date submitted for ethics approval [1] 314627 0
17/11/2023
Approval date [1] 314627 0
26/01/2024
Ethics approval number [1] 314627 0
19197

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

Contacts
Principal investigator
Name 132210 0
Prof Vincent M. Reid
Address 132210 0
The University of Waikato, Gate 1 Knighton Road, Hamilton East, 3240, Hamilton
Country 132210 0
New Zealand
Phone 132210 0
+64 78379593
Fax 132210 0
Email 132210 0
[email protected]
Contact person for public queries
Name 132211 0
Vincent M. Reid
Address 132211 0
The University of Waikato, Gate 1 Knighton Road, Hamilton East, 3240, Hamilton
Country 132211 0
New Zealand
Phone 132211 0
+64 78379593
Fax 132211 0
Email 132211 0
[email protected]
Contact person for scientific queries
Name 132212 0
Vincent M. Reid
Address 132212 0
The University of Waikato, Gate 1 Knighton Road, Hamilton East, 3240, Hamilton
Country 132212 0
New Zealand
Phone 132212 0
+64 78379593
Fax 132212 0
Email 132212 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21585Study protocol    387288-(Uploaded-07-02-2024-08-37-01)-Study-related document.pdf
21587Informed consent form    387288-(Uploaded-07-02-2024-08-37-12)-Study-related document.pdf



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.