UnknownNot Applicable

Bilateral Infant Stimulation Study

United States40 participantsStarted 2024-02-26

Plain-language 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. 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Parental anxiety

Timeframe: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention

Physiologic stress response

Timeframe: total length of recording approximately 20 minutes for each participate, analysis will look at several minute epochs prior to and following intervention

Parental distress

Timeframe: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention

Trial details

NCT IDNCT06353243

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08

Contact for this trial

Emily Garavatti

5034942634 garavatt@ohsu.edu

View on ClinicalTrials.gov More Parent-Child Relations trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Parental anxiety

Timeframe: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention

Physiologic stress response

Timeframe: total length of recording approximately 20 minutes for each participate, analysis will look at several minute epochs prior to and following intervention

Parental distress

Timeframe: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention