Assessing the Effects of Auricular Acupressure on Newborns With NAS

NCT03890562 | Completed DMC

• 1 other identifier: HM20006825
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome

Keywords

acupressure

Outcome Measures

Primary Outcomes (1)

• Number of participants recruited compared to number actually enrolled

  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.

  Beginning with IRB approval and ending when last eligible newborn completes the intervention. 6 months from IRB approval

Secondary Outcomes (1)

• Rate of participant (newborn) study completion

  Beginning with first signed consent form and ending when last eligible newborn completes the intervention. about 6 months from first signed consent form

Other Outcomes (2)

• List of behaviors exhibited by newborns with NAS during auricular acupressure intervention

  Beginning with first intervention and ending when last eligible newborn completes the intervention. about 6 months from first intervention

• The Modified Finnegan Score Scale numbers will decrease following intervention.

  changes from baseline through day 11

Study Arms (1)

Auricular acupressure for NAS infants

EXPERIMENTAL

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

Interventions

Auricular acupressure OTHER

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.

Auricular acupressure for NAS infants

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23222, United States

Location

Related Publications (3)

• Finnegan LP, Connaughton JF Jr, Kron RE, Emich JP. Neonatal abstinence syndrome: assessment and management. Addict Dis. 1975;2(1-2):141-58.

  PMID: 1163358 RESULT

• Tyme, L. (2001). Student Manual on the Fundamentals of Traditional Oriental Medicine (4th edition). Living Earth Enterprises, CA.

  RESULT

• Warnock F, Sandrin D. Comprehensive description of newborn distress behavior in response to acute pain (newborn male circumcision). Pain. 2004 Feb;107(3):242-255. doi: 10.1016/j.pain.2003.11.006.

  PMID: 14736587 RESULT

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lisa Brown, PhD, RN

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This feasibility study is a single group longitudinal pretest/posttest design

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: March 26, 2019
• Study Start: September 4, 2019
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

US (1)