Parent-Child RelationsBLISSNCT06353243
Bilateral Infant Stimulation Study
A study testing Bilateral alternating stimulation in people with Parent-Child Relations and Preterm Birth, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parent-Child Relations, Preterm Birth, Stress Reaction
- What is being tested?
- Bilateral alternating stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- admitted to the NICU at the time of study
- greater than 34 weeks gestational age and less than 43 weeks gestational age
- within 4 weeks of admission to NICU at time of initial contact
- have parent or legal guardian willing and able to participate in the study
Who cannot join
- those who are less than 3 days postop from surgical procedures
- current use of psychotropic medications or medications that affect the central nervous system (CNS)
- CNS anomaly.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Science University Neonatal Intensive Care Unit
Portland, Oregon, 97219
Emily Garavatti, MD, 503-494-2634, garavatt@ohsu.edu
About this study
Official title: Pilot of the Bilateral Infant Stimulation Study (BLISS): A Parent Provided Positive-Touch Intervention Targeting Stress in the Neonatal Intensive Care Unity (NICU)
This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention.
Read the detailed description
Objectives:
- Examine the effect of a bilateral alternating stimulation (BAS) NICU intervention on parental anxiety and psychological distress in the NICU using biological and self-report measurements.
- Examine the effect of a bilateral alternating stimulation NICU intervention on infants' physiological stress response after parental engagement in the BAS intervention with the infant.
This is a pilot study of bilateral alternating stimulation (BAS) examining the effectiveness as a therapeutic intervention for parental and infant stress in the NICU. It is a single arm design. Participants include parents and their infant that is currently admitted to the NICU. All participants will engage in parent-neonate intervention session, following this, infants will complete a delayed comparison arm (control session) with the interventionist. Infants currently admitted to NICU will be screened for eligibility, and if eligible, the families will be approached for enrollment. Families that enroll will be scheduled for one study session. During study session, parents will wear a heart rate monitor, complete psychologic scales of anxiety, stress, and feelings of closeness to thier infant, parents will be trained on the intervention and then engage in the intervention with their infant. Continuous vital signs will be collected for infant throughout the study session. After the intervention, parents will complete psychologic scales and satisfaction scales. Infants will then be scheduled for follow-up session where an interventionist will engage infant in intervention and vital signs will be collected throughout.
- Being tested
- Bilateral alternating stimulation
- Keywords
- neonates, heart rate variability, bilateral stimulation, positive touch, NICU
- Medical subject headings
- Premature Birth, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral alternating stimulationBehavioural
positive touch intervention provided by parent to infant using alternating stimulation
| Study group | Role | What they receive |
|---|---|---|
| Bilateral alternating Stimulation | Experimental | positive touch intervention provided by parent to infant using alternating stimulation Receives: Behavioral: Bilateral alternating stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental anxiety
Visual Analog Scale- Anxiety (VAS-A). The VAS scale asks participants to rate current anxiety on a horizontal line ranging from "calm" and "anxious" with scores between 0-100, with higher scores indicating higher levels of anxiety.
Measured: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention
Physiologic stress response
heart rate variability variable- the root mean square of successive differences (RMSSD) which reflects vagal tone
Measured: total length of recording approximately 20 minutes for each participate, analysis will look at several minute epochs prior to and following intervention
Parental distress
Distress Thermometer
Measured: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start26 Feb 2024
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Mackiewicz Seghete, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353243
- Sponsor's protocol ID
- STUDY00022901
- Acronym
- BLISS
- Status last verified
- May 2024
- First submitted
- 28 Mar 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of the Bilateral Infant Stimulation Study (BLISS): A Parent Provided Positive-Touch Intervention Targeting Stress in the Neonatal Intensive Care Unity (NICU)
- ClinicalTrials.gov ID
- NCT06353243
- Acronym / sponsor ID
- BLISS / STUDY00022901
- Keywords
- neonates, heart rate variability, bilateral stimulation, positive touch, NICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 9 Apr 2024 (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.
This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention.
Detailed description
Objectives:
- Examine the effect of a bilateral alternating stimulation (BAS) NICU intervention on parental anxiety and psychological distress in the NICU using biological and self-report measurements.
- Examine the effect of a bilateral alternating stimulation NICU intervention on infants' physiological stress response after parental engagement in the BAS intervention with the infant.
This is a pilot study of bilateral alternating stimulation (BAS) examining the effectiveness as a therapeutic intervention for parental and infant stress in the NICU. It is a single arm design. Participants include parents and their infant that is currently admitted to the NICU. All participants will engage in parent-neonate intervention session, following this, infants will complete a delayed comparison arm (control session) with the interventionist. Infants currently admitted to NICU will be screened for eligibility, and if eligible, the families will be approached for enrollment. Families that enroll will be scheduled for one study session. During study session, parents will wear a heart rate monitor, complete psychologic scales of anxiety, stress, and feelings of closeness to thier infant, parents will be trained on the intervention and then engage in the intervention with their infant. Continuous vital signs will be collected for infant throughout the study session. After the intervention, parents will complete psychologic scales and satisfaction scales. Infants will then be scheduled for follow-up session where an interventionist will engage infant in intervention and vital signs will be collected throughout.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral alternating Stimulation | Experimental | Behavioral: Bilateral alternating stimulationpositive touch intervention provided by parent to infant using alternating stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- admitted to the NICU at the time of study
- greater than 34 weeks gestational age and less than 43 weeks gestational age
- within 4 weeks of admission to NICU at time of initial contact
- have parent or legal guardian willing and able to participate in the study
Key exclusion criteria (3 listed)
- those who are less than 3 days postop from surgical procedures
- current use of psychotropic medications or medications that affect the central nervous system (CNS)
- CNS anomaly.
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 |
|---|---|---|
| Bilateral alternating stimulationpositive touch intervention provided by parent to infant using alternating stimulation | Behavioural | Bilateral alternating Stimulation |
Primary outcome
Parental anxiety
Time frame: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention
Visual Analog Scale- Anxiety (VAS-A). The VAS scale asks participants to rate current anxiety on a horizontal line ranging from "calm" and "anxious" with scores between 0-100, with higher scores indicating higher levels of anxiety.
Physiologic stress response
Time frame: total length of recording approximately 20 minutes for each participate, analysis will look at several minute epochs prior to and following intervention
heart rate variability variable- the root mean square of successive differences (RMSSD) which reflects vagal tone
Parental distress
Time frame: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention
Distress Thermometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
Related trials for Parent-Child Relations
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
Not yet recruiting
Hybrid Pilot of Personalized Parent-Child Interaction Therapy
Disruptive Behaviors
Active, not recruiting
Adapting the Sensory Environment to Reduce Stress in Children With Autism During Dental Visits
Autism, Autism Disorders and Maternal Stress
Recruiting
Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder
Autism
Active, not recruiting
CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
Parent-Child Relations, Parenting
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral alternating stimulation in people with Parent-Child Relations and Preterm Birth, run by Oregon Health and Science University at 1 site in United States.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 May 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily Garavatti (5034942634, garavatt@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental anxiety (time frame: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention). 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 3 May 2024.