Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes

Study Overview
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Brief Summary
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Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. It becomes important, therefore, to relieve preterm infants' pain and distress using multiple sensory integrations during peripheral venous puncture procedures.The proposed 2-year study has specific aim: to compare the effects of different combination of sensory integrations on preterm infants' pain and distress before, during, and after peripheral venous puncture procedures.

Official Title
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Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures

Conditions
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Pain, Preterm Infants

Intervention / Treatment
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* Other: Multiple Sensory Integrations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age (GA) 28-37 weeks Post-menstrual age (PMA) 29-38 weeks Postnatal age 3-28 days Sable condition (NTISSscore ≦ 22) Apgar scores≧7 at 5 minutes after birth Exclusion Criteria: Neurologic impairment Congenital anomalies Surgery Severe growth restriction at birth Severe medical conditions requiring treatments

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: routine care<br>Preterm infants in the control condition will receive only usual neonatal intensive care units (NICU) care | |
| Experimental: Multiple Sensory Integrations(1)<br>The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile). | Other: Multiple Sensory Integrations<br>* breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.<br>|
| Experimental: Multiple Sensory Integrations(2)<br>The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile). | Other: Multiple Sensory Integrations<br>* breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.<br>|
| Experimental: Multiple Sensory Integrations(3)<br>The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile). | Other: Multiple Sensory Integrations<br>* breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm infants' pain | Premature Infant Pain Profile-Revised (PIPP-R) for pain, A score <7 suggests no or little pain, 7-12 mild to moderate pain and scores >12 indicate moderate to severe pain. | 20-30 minutes (during peripheral venous puncture procedures) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm infants' physiological parameters:heart rate | Heart rate will be recorded from ECG leads. Heart rate in beats per minute (mean of physiological parameters) | 20-30 minutes (during peripheral venous puncture procedures) | 
| Preterm infants' physiological parameters:respiration rate | Respiration rate will be recorded from ECG leads. Respiration rate in breaths per minute. (mean of physiological parameters) | 20-30 minutes (during peripheral venous puncture procedures) | 
| Preterm infants' physiological parameters: oxygen saturation | Oxygen saturation will be recorded from ECG leads. Oxygen saturation in % (mean of physiological parameters) | 20-30 minutes (during peripheral venous puncture procedures) | 
| preterm infants' behavioral responses | The infant behavioral responses will be measured by using an infant behavioral coding scheme. Behavioral data during venous puncture procedures will be collected using a real-time colour video recorder. Frequency ratios for pain and distress behaviors, include: facial activity (e.g. brow bulge, eye squeeze, nasolabial furrow), body movement, cry, transition between sleep and wake states. | 20-30 minutes (during peripheral venous puncture procedures) | 
| preterm infants' duration of fussing and cry | Fussing and crying will be record from the recording pen in minutes. | 20-30 minutes (during peripheral venous puncture procedures) |