Preterm BirthNCT04762004
Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures
A study testing Maternal speech and Maternal singing in people with Preterm Birth and Pain, Procedural, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
Preterm infants undergo early separation from parents and are exposed to frequent painful clinical procedures, with resultant short- and long-term effects on their neurodevelopment. Read more about this study
- Who is it for?
- Ages 29 to 37 weeks
- Conditions the study is for
- Preterm Birth, Pain, Procedural
- What is being tested?
- Maternal speech and Maternal singing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Mar 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age >29 weeks gestational age at birth,
- weight >1000 g
- stable medical condition (absence of mechanical ventilation, no additional oxygen)
Who cannot join
- For infants
- no specific pathological conditions
- no genetic abnormalities
- For mothers
- history of substance abuse
- mental health problems
Trial locations and contacts
1 site in 1 country.
About this study
Preterm infants undergo early separation from parents and are exposed to frequent painful clinical procedures, with resultant short- and long-term effects on their neurodevelopment. We aimed to establish whether the mother's voice could provide an effective and safe analgesia for preterm infants and whether endogenous oxytocin (OXT) could be linked to pain modulation. Twenty preterm infants were exposed to three conditions-mother's live voice (speaking or singing) and standard care-in random order during a painful procedure. OXT levels (pg/mL) in saliva and plasma cortisol levels were quantified, and the Premature Infant Pain Profile (PIPP) was blindly coded by trained psychologists.
Read the detailed description
Preterm birth rates are continuously increasing in almost all countries, with 15 million premature infants being born every year worldwide1. Despite rapid advances in technology, the number of preterm-born children who show short- and long-term sequelae of prematurity, even before reaching school age, remains high. Around 40% of low birth weight preterm infants experience a complex spectrum of unfavourable neurodevelopmental outcomes when compared with their pairs at term. Thus, prematurity is of great concern for health policies in both low- and high-income countries. The impaired development of preterm infants is not only associated with medical factors, but it is also at least partly a consequence of the atypical early-life environment of these infants, including exposure to pain and separation from the primary caregivers.
The aim of the present work was first, to assess whether early closeness with parents during essential but painful clinical procedures could have a positive role in pain modulation in preterm infants, thus contributing to the universal right to pain relief. Second, we aimed to investigate the possible role of the oxytocinergic system in this putative pain modulation through maternal vocal contact.
In the present protocol, we introduce the effects of separation and early pain exposure as two environmental factors that are even more deleterious when concomitant, inducing short- and long-term problems in the preterm infant's development. We then suggest that there are protective effects of early closeness between parents and preterm infants in early care and, more specifically, of early vocal contact between parents and preterm infants during hospitalisation. Lastly, we discuss the role of oxytocin (OXT) as a crucial biomarker for attachment processes and in relation to brain inflammation due to stressful procedures for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Pain, Procedural
- Being tested
- Maternal speech, Maternal singing, Standard care
- Keywords
- Oxytocin, Maternal voice, Neonatal Intensive Care Unit
- Medical subject headings
- Premature Birth, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal speechBehavioural
In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures.
Maternal singingBehavioural
In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures.
Standard careBehavioural
the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).
| Study group | Role | What they receive |
|---|---|---|
| Maternal speech | Experimental | During the intervention, mothers were asked to speak to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min. Receives: Behavioral: Maternal speech |
| Maternal singing | Experimental | During the intervention, mothers were asked to sing to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min. Receives: Behavioral: Maternal singing |
| Standard care | Active comparator | During the control condition (without the mother), the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest). Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
The PIPP-R score is a cluster of physiological and behavioural measures. Physiological assessment was calculated on the heart rate and oxygen saturation levels as collected from the patient monitor by the researcher. Inter-rater reliability was assessed by three independent coders: expert coders 1 and 2 performed blinded ratings from offline muted videos and digitally recorded physiological parameters, whereas coder 3 was a trained nurse and performed a direct online rating of the scores. Higher levels of pain scores indicate higher levels of pain
Measured: Immediately after the procedure
oxytocin levels
Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception. Higher levels of oxytocin can indicate better pain protection.
Measured: Pre procedure
oxytocin levels
Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception. Higher levels of oxytocin can indicate better pain protection.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start7 Mar 2018
- Primary completion15 May 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover clinical trial with a repeated measures design. Each patient is assigned to a sequence of three treatments (maternal speech, maternal singing, and standard treatment).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Filippa, University of Geneva, Switzerland
- Investigators
- Didier M Grandjean, Professor, Study director, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762004
- Sponsor's protocol ID
- 90.513
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Speech Decreases Pain Scores and Increases Oxytocin Levels in Preterm Infants During Painful Procedures
- ClinicalTrials.gov ID
- NCT04762004
- Acronym / sponsor ID
- 90.513
- Conditions
- Preterm Birth, Pain, Procedural
- Keywords
- Oxytocin, Maternal voice, Neonatal Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm infants undergo early separation from parents and are exposed to frequent painful clinical procedures, with resultant short- and long-term effects on their neurodevelopment. We aimed to establish whether the mother's voice could provide an effective and safe analgesia for preterm infants and whether endogenous oxytocin (OXT) could be linked to pain modulation. Twenty preterm infants were exposed to three conditions-mother's live voice (speaking or singing) and standard care-in random order during a painful procedure. OXT levels (pg/mL) in saliva and plasma cortisol levels were quantified, and the Premature Infant Pain Profile (PIPP) was blindly coded by trained psychologists.
Detailed description
Preterm birth rates are continuously increasing in almost all countries, with 15 million premature infants being born every year worldwide1. Despite rapid advances in technology, the number of preterm-born children who show short- and long-term sequelae of prematurity, even before reaching school age, remains high. Around 40% of low birth weight preterm infants experience a complex spectrum of unfavourable neurodevelopmental outcomes when compared with their pairs at term. Thus, prematurity is of great concern for health policies in both low- and high-income countries. The impaired development of preterm infants is not only associated with medical factors, but it is also at least partly a consequence of the atypical early-life environment of these infants, including exposure to pain and separation from the primary caregivers.
The aim of the present work was first, to assess whether early closeness with parents during essential but painful clinical procedures could have a positive role in pain modulation in preterm infants, thus contributing to the universal right to pain relief. Second, we aimed to investigate the possible role of the oxytocinergic system in this putative pain modulation through maternal vocal contact.
In the present protocol, we introduce the effects of separation and early pain exposure as two environmental factors that are even more deleterious when concomitant, inducing short- and long-term problems in the preterm infant's development. We then suggest that there are protective effects of early closeness between parents and preterm infants in early care and, more specifically, of early vocal contact between parents and preterm infants during hospitalisation. Lastly, we discuss the role of oxytocin (OXT) as a crucial biomarker for attachment processes and in relation to brain inflammation due to stressful procedures for preterm infants in the neonatal intensive care unit (NICU).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Crossover clinical trial with a repeated measures design. Each patient is assigned to a sequence of three treatments (maternal speech, maternal singing, and standard treatment).
| Arm | Type | Receives |
|---|---|---|
| Maternal speech | Experimental | Behavioral: Maternal speechDuring the intervention, mothers were asked to speak to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min. |
| Maternal singing | Experimental | Behavioral: Maternal singingDuring the intervention, mothers were asked to sing to their preterm infants in the incubators for 5 min preceding the heel prick procedure and for the subsequent 5 min. |
| Standard care | Active comparator | Behavioral: Standard careDuring the control condition (without the mother), the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest). |
Who may qualify
- Ages
- 29 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age >29 weeks gestational age at birth,
- weight >1000 g
- stable medical condition (absence of mechanical ventilation, no additional oxygen)
Key exclusion criteria (6 listed)
- For infants
- no specific pathological conditions
- no genetic abnormalities
- For mothers
- history of substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal speechIn both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures. | Behavioural | Maternal speech |
| Maternal singingIn both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures. | Behavioural | Maternal singing |
| Standard carethe newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest). | Behavioural | Standard care |
Primary outcome
pain score
Time frame: Immediately after the procedure
The PIPP-R score is a cluster of physiological and behavioural measures. Physiological assessment was calculated on the heart rate and oxygen saturation levels as collected from the patient monitor by the researcher. Inter-rater reliability was assessed by three independent coders: expert coders 1 and 2 performed blinded ratings from offline muted videos and digitally recorded physiological parameters, whereas coder 3 was a trained nurse and performed a direct online rating of the scores. Higher levels of pain scores indicate higher levels of pain
oxytocin levels
Time frame: Pre procedure
Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception. Higher levels of oxytocin can indicate better pain protection.
oxytocin levels
Time frame: Immediately after the procedure
Early relational experiences can persistently affect social behaviours by modifying the oxytocin system and endogenous oxytocin regulation is a potential protective mechanism for early pain perception. Higher levels of oxytocin can indicate better pain protection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier M Grandjean, Professor study director
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal speech and Maternal singing in people with Preterm Birth and Pain, Procedural, run by University of Geneva, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: Immediately after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.