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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
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Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.
Preterm infants will receive one episode of essential nursing care as standard care and one episode of essential nursing care that includes a nurse-administered comforting touch intervention approximately 24 hours apart in a randomized sequence. For 10 minutes prior to the start of the two observed care episodes, during the care episodes, and for 60 minutes after the conclusion of the care episodes, researchers will measure infants' biobehavioral stress responses. When infants reach 35 weeks post-menstrual age, researchers will perform a neurobehavioral assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse-Administered Touch Intervention | Experimental | Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care. |
|
| Standard Care | No Intervention | Preterm infants will receive one episode of essential nursing care delivered as standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-Administered Touch Intervention | Behavioral | The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Heart Rate -- During Intervention | heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period | during intervention or control period, approximately 20 minutes |
| Average Heart Rate -- Recovery | heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period | recovery, 30 minutes after intervention delivery or control period |
| Measure | Description | Time Frame |
|---|---|---|
| Average High-frequency Heart Rate Variability -- During Caregiving Episode | Spectral analysis of high-frequency heart rate variability averaged over the episode of caregiving during which infants received either the nurse-administered touch intervention or standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marliese D. Nist, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Nurse-Administered Touch Intervention, Then Standard Care | Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care provided as standard care. Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode. Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine. |
| FG001 | Experimental: Standard Care, Then Nurse-Administered Touch Intervention | Preterm infants will receive one episode of essential nursing care delivered as standard care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care that includes the nurse-administered touch intervention. Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine. Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
10 infants assigned to receive nurse-administered touch intervention followed by standard care sequence; 9 infants assigned to receive standard care followed by nurse-administered touch intervention sequence
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Nurse-Administered Touch Intervention, Then Standard Care | Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care followed by a 24-hour washout period. Then, infants will receive one episode of essential nursing care provided as standard care. Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode. Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Heart Rate -- During Intervention | heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period | 19 enrolled infants in randomized cross-over trial | Posted | Mean | Standard Deviation | beats per minute | during intervention or control period, approximately 20 minutes |
|
Essential nursing care is scheduled to occur every 3 hours in the NICU. Study electrodes were attached to enrolled infants during the caregiving episode preceding the observed caregiving episode during which data collection occurred. Adverse events were documented from the time study electrodes were attached to the infant until the end of the 30-minute recovery period following the observed caregiving episode. Thus, total recording of adverse events was approximately 3.5 hours.
standard definition applied
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nurse-Administered Touch Intervention | Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care. Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bradycardia or oxygen desaturation | General disorders | Systematic Assessment | episode of bradycardia with heart rate <100 beats per minute for 10 seconds and/or oxygen desaturation with SpO2 <85% for 10 seconds |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marliese D. Nist | The Ohio State University College of Nursing | 614-247-5781 | nist.10@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2021 | Dec 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 8, 2021 | Dec 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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randomized cross-over design
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The statistician performing the data analysis will be blinded to group.
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|
| during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes |
| Average High-frequency Heart Rate Variability -- Recovery | Spectral analysis of high-frequency heart rate variability averaged over the 30-minute period following caregiving that included the nurse-administered touch intervention or was delivered as standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone. | recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care |
| Average Frequency of Skin Conductance Responses -- During Caregiving Episode | Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the caregiving episode that includes either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of caregiving. | during caregiving episode, approximately 20 minutes |
| Average Frequency of Skin Conductance Responses -- Recovery | Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the 30-minute period following the caregiving episode that included either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of the 30-minute recovery period. | recovery, 30 minutes after intervention delivery or control period |
| BG001 | Experimental: Standard Care, Then Nurse-Administered Touch Intervention | Preterm infants will receive one episode of essential nursing care delivered as standard care followed by a 24-hour washout period. Then, infants will receive an episode of essential nursing care that includes the nurse-administered touch intervention. Standard Care: Essential nursing care includes activities to address infant clinical and hygiene needs and may include discretionary comforting touch. Systematic comforting touch is not routine. Nurse-Administered Touch Intervention: The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | weeks gestation at birth |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Birthweight | Mean | Full Range | grams |
|
| OG001 | Standard Care | Preterm infants will receive one episode of essential nursing care delivered as standard care. |
|
|
| Primary | Average Heart Rate -- Recovery | heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period | 19 total infants participated in randomized cross-over trial | Posted | Mean | Standard Deviation | beats per minute | recovery, 30 minutes after intervention delivery or control period |
|
|
|
| Secondary | Average High-frequency Heart Rate Variability -- During Caregiving Episode | Spectral analysis of high-frequency heart rate variability averaged over the episode of caregiving during which infants received either the nurse-administered touch intervention or standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone. | 19 total participants in randomized cross-over trial | Posted | Median | Full Range | ln(ms^2) | during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes |
|
|
|
| Secondary | Average High-frequency Heart Rate Variability -- Recovery | Spectral analysis of high-frequency heart rate variability averaged over the 30-minute period following caregiving that included the nurse-administered touch intervention or was delivered as standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone. | 19 total participants in randomized cross-over trial | Posted | Median | Full Range | ln(ms^2) | recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care |
|
|
|
| Secondary | Average Frequency of Skin Conductance Responses -- During Caregiving Episode | Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the caregiving episode that includes either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of caregiving. | 19 total participants in randomized cross-over trial | Posted | Mean | Standard Deviation | waves per second | during caregiving episode, approximately 20 minutes |
|
|
|
| Secondary | Average Frequency of Skin Conductance Responses -- Recovery | Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the 30-minute period following the caregiving episode that included either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of the 30-minute recovery period. | 19 total participants in randomized cross-over trial | Posted | Mean | Standard Deviation | waves per second | recovery, 30 minutes after intervention delivery or control period |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 5 |
| 19 |
| EG001 | Standard Care | Preterm infants will receive one episode of essential nursing care delivered as standard care. | 0 | 18 | 0 | 18 | 8 | 18 |
|
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| D000091642 | Urogenital Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |