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

National Defense Medical Center, Taiwan

Status: Completed

Conditions: Preterm Infants; Pain

Treatments: Other: Multiple Sensory Integrations

Study type: Interventional

Funder types: Other

Identifiers

NCT03252327

2-106-05-080

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 3 to 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 4 patient groups

routine care

No Intervention group

Description:

Preterm infants in the control condition will receive only usual neonatal intensive care units (NICU) care

Multiple Sensory Integrations(1)

Experimental group

Description:

The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).

Treatment:

Other: Multiple Sensory Integrations

Multiple Sensory Integrations(2)

Experimental group

Description:

The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).

Treatment:

Other: Multiple Sensory Integrations

Multiple Sensory Integrations(3)

Experimental group

Description:

The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).

Treatment:

Other: Multiple Sensory Integrations