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Assessing the Effects of Auricular Acupressure on Newborns With NAS

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: NCT03890562
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:

This study will determine the feasibility of using auricular acupressure as an intervention in newborns with neonatal abstinence syndrome(NAS). Auricular acupuncture has been used as an intervention in adults in withdrawal by the National Acupuncture Detoxification Association with good results. The same points on the ear used by National Acupuncture Detoxification Association (NADA) will be used in this intervention using a spring-loaded microprobe to apply minimal pressure instead of needles.

The purpose of this study is to identify barriers to recruiting newborns with NAS; to identify newborn behaviors during the intervention that determine tolerance of the intervention, and to compare results of vitals signs and withdrawal scores prior to intervention and post-intervention.


Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Other: Auricular acupressure Not Applicable

Detailed Description:

After Institutional Review Board (IRB) approval, the Primary Investigator (PI) will make daily calls to the units to ascertain whether any newborns have been admitted with a positive drug screen. The researcher will go to the mother's private room after delivery to explain the study. Consents and demographic data will be acquired. The PI will make daily calls to the units to ascertain whether the consented newborns have started on treatment for signs of withdrawal. Before each intervention visit, the PI will call the unit to confirm the newborns feeding schedule with the assigned nurse and arrange for a convenient time to perform the intervention. The intervention will begin on day 1 of pharmacological treatment for withdrawal signs of NAS by the medical staff. The intervention will be provided six times over a 2-week period on day 1,3,5,7,9, and 11 of treatment as recommended by the consulting acupuncturist.

On the day of the intervention the PI will arrive 45 minutes prior to the feeding to perform the following (1) scrub in, (2) set up the secluded area for treatment if infant is not in a private room, (3) transport the newborn to the private/secluded area in the nursery/Neonatal Intensive Care Unit (NICU) if with the mother or in one of the nurseries, (4) perform vital signs (about 3 minutes) and assess ears for any signs of redness or bruising, (5) implement the intervention (approximately 5 minutes), and (6) perform vital signs 5 minutes' post-intervention with post-assessment of ears for any signs of redness or bruising.

Acupressure will be implemented by the PI, using a stainless steel spring-loaded probe to apply small amounts of pressure to the 5 points on the newborn's inner earlobe. The stainless-steel probe will be thoroughly cleaned with alcohol between each newborn. Pressure is given over a 30 second period for each site on the ear and then repeated on the opposite ear. The proposed study will include a fixed intervention as the same intervention will be given to all participants in the treatment group.

The behaviors exhibited by the newborn during intervention will be recorded. Distress signs will be monitored. If they continue for greater than a minute or impede the successful implementation of the intervention, then the intervention will be stopped. The newborn will be soothed and comforted for no greater than ten minutes. If calm after soothing, then intervention will proceed. If the same distress signs are exhibited again, then the intervention will be stopped for the day.

Five minutes' post-intervention the PI will reassess vital signs. The Modified Finnegan Scoring Scale (MFSS) will be taken from the chart for the assessment prior to the intervention and scores immediately post-intervention. Infants who were removed from the mother's room will be returned. Total time for intervention infants should be approximately 35-40 minutes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This feasibility study is a single group longitudinal pretest/posttest design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Effects of Auricular Acupressure on Newborn Behaviors and Withdrawal Signs in Newborns With Neonatal Abstinence Syndrome: A Pilot Study
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: Auricular acupressure for NAS infants
Auricular acupressure will be applied to five specific acupressure points using a stainless-steel acupressure probe. The five auricular points are: (1) Shen Men, 2) Sympathetic, (3) Kidney, (4) Lung, and (5) Liver. (Tyme, 2001). These sites have been identified by the National Acupuncture Detoxification Association and used for the treatment of withdrawal in adults.
Other: Auricular acupressure
Auricular acupressure will be applied to five specific acupressure points using a stainless-steel acupressure probe. The five auricular points are: (1) Shen Men, 2) Sympathetic, (3) Kidney, (4) Lung, and (5) Liver. (Tyme, 2001). These sites have been identified by the National Acupuncture Detoxification Association and used for the treatment of withdrawal in adults.




Primary Outcome Measures :
  1. Number of participants recruited compared to number actually enrolled [ Time Frame: Beginning with IRB approval and ending when last eligible newborn completes the intervention. 6 months from IRB approval ]
    The study will collect data on the difficulty or lack thereof in recruiting the participants for the proposed study. How many mothers of newborns with withdrawal symptoms were approached to participate, agreed to participate, or refused to allow their newborn to be a part of the study? If the mother refused, why did she refuse.


Secondary Outcome Measures :
  1. Rate of participant (newborn) study completion [ Time Frame: Beginning with first signed consent form and ending when last eligible newborn completes the intervention. about 6 months from first signed consent form ]
    Number of newborns who completed the final study visit compared to total number of signed consent forms signaling that newborns were enrolled the study


Other Outcome Measures:
  1. List of behaviors exhibited by newborns with NAS during auricular acupressure intervention [ Time Frame: Beginning with first intervention and ending when last eligible newborn completes the intervention. about 6 months from first intervention ]
    Newborn behaviors will be recorded during each of the 6 auricular intervention. Behaviors will be logged and noted as indicating distress or indicating tolerance. Behaviors will be compared across all newborns in study.

  2. The Modified Finnegan Score Scale numbers will decrease following intervention. [ Time Frame: changes from baseline through day 11 ]
    The Modified Finnegan is a paper and pencil instrument that assesses three major newborn systems: (1) the central nervous system, (2) metabolic/respiratory/vasomotor system, and (3) the gastrointestinal system to quantify withdrawal symptoms with a score of 8 or greater indicating significant withdrawal.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 36 weeks gestation
  • Newborns with positive drug screen and initiation of treatment for withdrawal

Exclusion Criteria:

  • Prematurity (< 36 weeks' gestation)
  • Any major disease/ illness at birth (e.g. sepsis, necrotizing enterocolitis, gastroenteritis, respiratory disease, cardiac anomalies, anatomical malformation of ears) that could potentially confound the withdrawal symptoms

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): NCT03890562


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23222
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Lisa Brown, PhD, RN Virginia Commonwealth University
Publications of Results:
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03890562    
Other Study ID Numbers: HM20006825
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
acupressure
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders