Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03252327
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Hsiang-Ping Wu, 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.

Condition or disease Intervention/treatment Phase
Preterm Infants Pain Other: Multiple Sensory Integrations Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures
Actual Study Start Date : August 26, 2017
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : July 31, 2018

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

Experimental: Multiple Sensory Integrations(2)
The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
Other: Multiple Sensory Integrations
breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.

Experimental: Multiple Sensory Integrations(3)
The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
Other: Multiple Sensory Integrations
breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.




Primary Outcome Measures :
  1. Preterm infants' pain [ Time Frame: 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 :
  1. preterm infants' physiological parameters:heart rate [ Time Frame: 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)

  2. Preterm infants' physiological parameters:respiration rate [ Time Frame: 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)

  3. Preterm infants' physiological parameters: oxygen saturation [ Time Frame: 20-30 minutes (during peripheral venous puncture procedures) ]
    Oxygen saturation will be recorded from ECG leads. Oxygen saturation in % (mean of physiological parameters)

  4. preterm infants' behavioral responses [ Time Frame: 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.

  5. preterm infants' duration of fussing and cry [ Time Frame: 20-30 minutes (during peripheral venous puncture procedures) ]
    Fussing and crying will be record from the recording pen in minutes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252327


Locations
Layout table for location information
Taiwan
Tri-Service General Hospital
Taipei, Taiwan, 114
Sponsors and Collaborators
National Defense Medical Center, Taiwan
Ministry of Science and Technology, Taiwan

Layout table for additonal information
Responsible Party: Hsiang-Ping Wu, Principal Investigator, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier: NCT03252327     History of Changes
Other Study ID Numbers: 2-106-05-080
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications