Infant BehaviorMSINCT04851353
Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
A study testing GT+VC, Smell and Taste in people with Infant Behavior and Pain, Acute, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures. Read more about this study
- Who is it for?
- Ages 2 days to 1 weekHealthy volunteers can take part
- Conditions the study is for
- Infant Behavior, Pain, Acute, Physiological Stress
- What is being tested?
- GT+VC, Smell and Taste
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Sep 2017to 25 Sep 2018
- 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 2 days to 1 week
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age > 36 weeks, birth weight > 2200 g, and at least one parent agreed to participate.
Who cannot join
- had congenital anomalies and neurologic impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast Milk as Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures.
Read the detailed description
Newborns undergo many necessary invasive procedures for routine care, but these treatments may cause stress and pain. The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures. This study was a prospective, randomized controlled trial. Infants were recruited by convenience sampling in a baby room of a medical center in northern Taiwan from September in 2017 to September in 2018. Newborns who met the criteria were recruited by blocked random to three treatment groups: (1)Gentle touch + Verbal comfort, (2) Smell + gentle touch + Verbal comfort, (3) Smell + Taste + Touch + Verbal comfort. Pain response was measured by the Neonatal Infant Pain Scale (NIPS). The physical distress events were measured by the abnormal heart rate and oxygen saturation event, and crying event. All data were collected 5 minutes before heel-stick (baseline), during heel-stick and in recovery status.
- Conditions
- Infant Behavior, Pain, Acute, Physiological Stress, Breast Milk
- Being tested
- GT+VC, Smell, Taste
- Medical subject headings
- Infant Behavior, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT+VCBehavioural
Gentle touch and verbal comfort,
SmellBehavioural
Smell breast milk
TasteBehavioural
Taste breast milk
| Study group | Role | What they receive |
|---|---|---|
| GT+VC | Active comparator | Gentle touch +Verbal comfort Receives: Behavioral: GT+VC |
| GT+VC+Smell | Experimental | Gentle touch +Verbal comfort+ Smell breast milk Receives: Behavioral: GT+VC; Behavioral: Smell |
| GT+VC+Smell+Taste | Experimental | Gentle touch +Verbal comfort+ Smell breast milk+ Taste milk Receives: Behavioral: GT+VC; Behavioral: Smell; Behavioral: Taste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infants' pain reponse
Neonatal Infant Pain Scale
Measured: Six months
Secondary outcomes (1)
The distress events of physiological parameters
Heart rate, oxygen saturation, and crying event
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start26 Sep 2017
- Primary completion28 Feb 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant BehaviorStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiang-Yun Lan, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851353
- Sponsor's protocol ID
- 1-106-05-136
- Acronym
- MSI
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 20 Apr 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 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Milk as Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
- ClinicalTrials.gov ID
- NCT04851353
- Acronym / sponsor ID
- MSI / 1-106-05-136
- Conditions
- Infant Behavior, Pain, Acute, Physiological Stress, Breast Milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 20 Apr 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.
The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures.
Detailed description
Newborns undergo many necessary invasive procedures for routine care, but these treatments may cause stress and pain. The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures. This study was a prospective, randomized controlled trial. Infants were recruited by convenience sampling in a baby room of a medical center in northern Taiwan from September in 2017 to September in 2018. Newborns who met the criteria were recruited by blocked random to three treatment groups: (1)Gentle touch + Verbal comfort, (2) Smell + gentle touch + Verbal comfort, (3) Smell + Taste + Touch + Verbal comfort. Pain response was measured by the Neonatal Infant Pain Scale (NIPS). The physical distress events were measured by the abnormal heart rate and oxygen saturation event, and crying event. All data were collected 5 minutes before heel-stick (baseline), during heel-stick and in recovery status.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GT+VC | Active comparator | Behavioral: GT+VCGentle touch +Verbal comfort |
| GT+VC+Smell | Experimental | Behavioral: GT+VC, Behavioral: SmellGentle touch +Verbal comfort+ Smell breast milk |
| GT+VC+Smell+Taste | Experimental | Behavioral: GT+VC, Behavioral: Smell, Behavioral: TasteGentle touch +Verbal comfort+ Smell breast milk+ Taste milk |
Who may qualify
- Ages
- 2 days to 1 week
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age > 36 weeks, birth weight > 2200 g, and at least one parent agreed to participate.
Key exclusion criteria (1 listed)
- had congenital anomalies and neurologic impairment
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 |
|---|---|---|
| GT+VCGentle touch and verbal comfort, | Behavioural | GT+VC, GT+VC+Smell, GT+VC+Smell+Taste |
| SmellSmell breast milk | Behavioural | GT+VC+Smell, GT+VC+Smell+Taste |
| TasteTaste breast milk | Behavioural | GT+VC+Smell+Taste |
Primary outcome
Infants' pain reponse
Time frame: Six months
Neonatal Infant Pain Scale
1 secondary outcome
The distress events of physiological parameters
Time frame: Six months
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 20 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GT+VC, Smell and Taste in people with Infant Behavior and Pain, Acute, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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 1 inclusion and 1 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 20 Apr 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 Taiwan. 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?
Infants' pain reponse (time frame: Six months). 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 20 Apr 2021.