- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03252327
Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes
May 9, 2019 updated by: Hsiang-Ping Wu, National Defense Medical Center, Taiwan
Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 114
- Tri-service general hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 days to 4 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
|
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).
|
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).
|
breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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20-30 minutes (during peripheral venous puncture procedures)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
20-30 minutes (during peripheral venous puncture procedures)
|
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)
|
20-30 minutes (during peripheral venous puncture procedures)
|
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)
|
20-30 minutes (during peripheral venous puncture procedures)
|
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.
|
20-30 minutes (during peripheral venous puncture procedures)
|
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.
|
20-30 minutes (during peripheral venous puncture procedures)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 26, 2017
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
August 8, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (Actual)
August 17, 2017
Study Record Updates
Last Update Posted (Actual)
May 13, 2019
Last Update Submitted That Met QC Criteria
May 9, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-106-05-080
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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