Cracking the Code of Crying Babies: How Familiarity Changes the Interpretation of Cries

NCT ID: NCT05170178

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-05-12

Brief Summary

Understanding babies' signals is essential to meet their needs. Recent works suggest that crying provides useful information, not only allowing parents to recognize their baby among others (static information), but also to distinguish between mild discomfort and pain cries (dynamic information). The perception of this information by adults involves a "parental" brain network including brain areas involved in empathy, attention, emotional regulation, motor as well as regions of the limbic system or associated with the reward network.

Detailed Description

This network is involved when listening to cries of familiar babies, or pain cries. How do we become specialist of a baby's cries? To date, no functional imaging study has examined the specific brain activations when listening to the cries of a familiar baby in different situations, particularly painful ones.

Conditions

Magnetic Resonance Imaging; Neuronal Activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Women with parental experience caring for infants

Women parent of a child under 2 years old

Group Type: EXPERIMENTAL

inclusion and familiarization

Intervention Type: BEHAVIORAL

• presentation of the study purpose and the protocol to the volunteer
• clinical examination to check inclusion and exclusion criteria
• Familiarization with the crying of one assigned baby, by listening to several bath cries from this baby

fMRI acquisition and closure

Intervention Type: BEHAVIORAL

• Second phase of familiarization, listening again to bath cries of "their" assigned baby. These cries will be different from those listened during the first familiarization phase.
• MRI acquisition: after acquisition of the anatomical images (5 min), the subjects will listen to 64 cries divided into 4 functional MRI sessions of 10 minutes each. The cries will be those of "their" baby or of unknown babies, evoked in a painful (vaccination) or a non-painful (bath) situation, presented in a pseudo-random order. Participants will be asked to assess whether they recognize "their" baby (yes/no) and whether they recognize a pain cry (yes/no).
• debriefing
• Protocol ending

Men with parental experience caring for infants

Men parent of a child under 2 years old

Group Type: EXPERIMENTAL

inclusion and familiarization

Intervention Type: BEHAVIORAL

• presentation of the study purpose and the protocol to the volunteer
• clinical examination to check inclusion and exclusion criteria
• Familiarization with the crying of one assigned baby, by listening to several bath cries from this baby

fMRI acquisition and closure

Intervention Type: BEHAVIORAL

• Second phase of familiarization, listening again to bath cries of "their" assigned baby. These cries will be different from those listened during the first familiarization phase.
• MRI acquisition: after acquisition of the anatomical images (5 min), the subjects will listen to 64 cries divided into 4 functional MRI sessions of 10 minutes each. The cries will be those of "their" baby or of unknown babies, evoked in a painful (vaccination) or a non-painful (bath) situation, presented in a pseudo-random order. Participants will be asked to assess whether they recognize "their" baby (yes/no) and whether they recognize a pain cry (yes/no).
• debriefing
• Protocol ending

Women with professional experience in caring for infants

Women in daily contact with infants in professional circle (e.g., nannies, pediatricians, midwives, maternity nurses) without dependent children under 2 years old

Group Type: EXPERIMENTAL

inclusion and familiarization

Intervention Type: BEHAVIORAL

• presentation of the study purpose and the protocol to the volunteer
• clinical examination to check inclusion and exclusion criteria
• Familiarization with the crying of one assigned baby, by listening to several bath cries from this baby

fMRI acquisition and closure

Intervention Type: BEHAVIORAL

• Second phase of familiarization, listening again to bath cries of "their" assigned baby. These cries will be different from those listened during the first familiarization phase.
• MRI acquisition: after acquisition of the anatomical images (5 min), the subjects will listen to 64 cries divided into 4 functional MRI sessions of 10 minutes each. The cries will be those of "their" baby or of unknown babies, evoked in a painful (vaccination) or a non-painful (bath) situation, presented in a pseudo-random order. Participants will be asked to assess whether they recognize "their" baby (yes/no) and whether they recognize a pain cry (yes/no).
• debriefing
• Protocol ending

Interventions

inclusion and familiarization

• presentation of the study purpose and the protocol to the volunteer
• clinical examination to check inclusion and exclusion criteria
• Familiarization with the crying of one assigned baby, by listening to several bath cries from this baby

Intervention Type: BEHAVIORAL

fMRI acquisition and closure

• Second phase of familiarization, listening again to bath cries of "their" assigned baby. These cries will be different from those listened during the first familiarization phase.
• MRI acquisition: after acquisition of the anatomical images (5 min), the subjects will listen to 64 cries divided into 4 functional MRI sessions of 10 minutes each. The cries will be those of "their" baby or of unknown babies, evoked in a painful (vaccination) or a non-painful (bath) situation, presented in a pseudo-random order. Participants will be asked to assess whether they recognize "their" baby (yes/no) and whether they recognize a pain cry (yes/no).
• debriefing
• Protocol ending

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

For all volunteers:

• Affiliated or entitled to a social security plan
• Right-handed by the Edinburgh laterality test
• Having given free, informed and written consent to participate in the study
• Having given their consent for the communication of the MRI results to their attending physician

Group with parental experience caring for infants :

• Men or women between 18 and 50 years old
• Parent of a child under 2 years old

Group with professional experience in caring for infants

• Women between 18 and 50 years old
• Without dependent children under 2 years of age
• People in daily contact with infants in the professional circle (e.g. nurses, pediatricians, midwives, maternity nurses, etc)

Exclusion Criteria

• Pregnant women, parturient, nursing mothers or parents
• Persons deprived of liberty, hospitalized without consent, hospitalized for purposes other than research
• Minors
• Adults under legal protection (guardianship) or unable to express their consent
• Subjects with contraindications to the MRI examination: use of a pacemaker or an insulin pump, wearing a metallic prothesis, an intracerebral clip or a piercing, claustrophobia,
• Taking medication for less than 12 hours,
• Neurological, psychiatric or auditory history or deficits.
• Anxiety and/or depressive disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland PEYRON, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

HCL

Bron, , France

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

21CH161

Identifier Type: -

Identifier Source: org_study_id