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

Primary Purpose

Preterm Infants, Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Multiple Sensory Integrations
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infants

Eligibility Criteria

3 Days - 28 Days (Child)All SexesAccepts 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

Sites / Locations

  • Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

routine care

Multiple Sensory Integrations(1)

Multiple Sensory Integrations(2)

Multiple Sensory Integrations(3)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

preterm infants' physiological parameters:heart rate
Heart rate will be recorded from ECG leads. Heart rate in beats per minute (mean of physiological parameters)
Preterm infants' physiological parameters:respiration rate
Respiration rate will be recorded from ECG leads. Respiration rate in breaths per minute. (mean of physiological parameters)
Preterm infants' physiological parameters: oxygen saturation
Oxygen saturation will be recorded from ECG leads. Oxygen saturation in % (mean of physiological parameters)
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.
preterm infants' duration of fussing and cry
Fussing and crying will be record from the recording pen in minutes.

Full Information

First Posted
August 8, 2017
Last Updated
May 9, 2019
Sponsor
National Defense Medical Center, Taiwan
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03252327
Brief Title
Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes
Official Title
Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 26, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
routine care
Arm Type
No Intervention
Arm Description
Preterm infants in the control condition will receive only usual neonatal intensive care units (NICU) care
Arm Title
Multiple Sensory Integrations(1)
Arm Type
Experimental
Arm Description
The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
Arm Title
Multiple Sensory Integrations(2)
Arm Type
Experimental
Arm Description
The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
Arm Title
Multiple Sensory Integrations(3)
Arm Type
Experimental
Arm Description
The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
Intervention Type
Other
Intervention Name(s)
Multiple Sensory Integrations
Intervention Description
breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.
Primary Outcome Measure Information:
Title
Preterm infants' pain
Description
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.
Time Frame
20-30 minutes (during peripheral venous puncture procedures)
Secondary Outcome Measure Information:
Title
preterm infants' physiological parameters:heart rate
Description
Heart rate will be recorded from ECG leads. Heart rate in beats per minute (mean of physiological parameters)
Time Frame
20-30 minutes (during peripheral venous puncture procedures)
Title
Preterm infants' physiological parameters:respiration rate
Description
Respiration rate will be recorded from ECG leads. Respiration rate in breaths per minute. (mean of physiological parameters)
Time Frame
20-30 minutes (during peripheral venous puncture procedures)
Title
Preterm infants' physiological parameters: oxygen saturation
Description
Oxygen saturation will be recorded from ECG leads. Oxygen saturation in % (mean of physiological parameters)
Time Frame
20-30 minutes (during peripheral venous puncture procedures)
Title
preterm infants' behavioral responses
Description
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.
Time Frame
20-30 minutes (during peripheral venous puncture procedures)
Title
preterm infants' duration of fussing and cry
Description
Fussing and crying will be record from the recording pen in minutes.
Time Frame
20-30 minutes (during peripheral venous puncture procedures)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan

12. IPD Sharing Statement

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

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