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

Not Applicable

Completed

• Conditions: Preterm Infants; Pain
• Interventions: Other: Multiple Sensory Integrations

• Registration Number: NCT03252327
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-17
• Study Start: 2017-08-26
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Sensory Integrations(3)	Multiple Sensory Integrations	The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
Multiple Sensory Integrations(2)	Multiple Sensory Integrations	The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
Multiple Sensory Integrations(1)	Multiple Sensory Integrations	The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).

Primary Outcome Measures

Name	Time	Method
Preterm infants' pain	20-30 minutes (during peripheral venous puncture procedures)	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.

Secondary Outcome Measures

Name	Time	Method
Preterm infants' physiological parameters: oxygen saturation	20-30 minutes (during peripheral venous puncture procedures)	Oxygen saturation will be recorded from ECG leads. Oxygen saturation in % (mean of physiological parameters)
preterm infants' physiological parameters:heart rate	20-30 minutes (during peripheral venous puncture procedures)	Heart rate will be recorded from ECG leads. Heart rate in beats per minute (mean of physiological parameters)
Preterm infants' physiological parameters:respiration rate	20-30 minutes (during peripheral venous puncture procedures)	Respiration rate will be recorded from ECG leads. Respiration rate in breaths per minute. (mean of physiological parameters)
preterm infants' duration of fussing and cry	20-30 minutes (during peripheral venous puncture procedures)	Fussing and crying will be record from the recording pen in minutes.
preterm infants' behavioral responses	20-30 minutes (during peripheral venous puncture procedures)	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.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan