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Pilot Study of Nursing Touch and Biobehavioral Stress
NA trial testing Nurse-Administered Touch Intervention in Prematurity in 19 participants. Completed in 17 May 2022.
| Lead sponsor | Ohio State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 19 |
| Start date | 10 September 2021 |
| Primary completion | 20 April 2022 |
| Estimated completion | 17 May 2022 |
| Sites | 1 location across United States |
Ohio State University
Under 10 Days, any sex, with Prematurity or Stress Reaction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
| Group | Value | 95% CI |
|---|---|---|
| Nurse-Administered Touch Intervention | 172.6 | ± 10.5 |
| Standard Care | 168.6 | ± 9.2 |
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
| Group | Value | 95% CI |
|---|---|---|
| Nurse-Administered Touch Intervention | 161.7 | ± 10.0 |
| Standard Care | 158.6 | ± 8.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Nurse-Administered Touch Intervention | 3.2 | 2.1 – 4.8 |
| Standard Care | 3.2 | 2.5 – 4.3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Nurse-Administered Touch Intervention | 3.0 | 2.1 – 5.5 |
| Standard Care | 3.0 | 2.3 – 4.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Nurse-Administered Touch Intervention | 0.14 | ± 0.05 |
| Standard Care | 0.14 | ± 0.05 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Nurse-Administered Touch Intervention | 0.06 | ± 0.04 |
| Standard Care | 0.06 | ± 0.05 |
Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Nurse-Administered Touch I… | Standard Care |
|---|---|---|---|
| bradycardia or oxygen desaturation | General disorders | — | — |
Data from ClinicalTrials.gov NCT05030233 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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