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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252327
• Other study ID #: 2-106-05-080
• Status: Completed
• Phase: N/A
• Start date: August 26, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: May 2019
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Premature Birth
• Preterm Infants

Intervention

Other:
• Multiple Sensory Integrations
breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)