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Completed

NCT Number: NCT03252327

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

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.

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Key information

Conditions

Preterm Infants Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, 114, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiple Sensory Integrations

Other

breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2017
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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