Assessing the Effects of Auricular Acupressure on Newborns With NAS

Neonatal Abstinence Syndrome Clinical Trial

Official title:

Assessing the Effects of Auricular Acupressure on Newborn Behaviors and Withdrawal Signs in Newborns With Neonatal Abstinence Syndrome: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890562
• Other study ID #: HM20006825
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: March 5, 2021

Study information

• Verified date: April 2021
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	List of behaviors exhibited by newborns with NAS during auricular acupressure 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.	Beginning with first intervention and ending when last eligible newborn completes the intervention. about 6 months from first intervention
Other	The Modified Finnegan Score Scale numbers will decrease following intervention.	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.	changes from baseline through day 11
Primary	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	Rate of participant (newborn) study completion	Number of newborns who completed the final study visit compared to total number of signed consent forms signaling that newborns were enrolled the study	Beginning with first signed consent form and ending when last eligible newborn completes the intervention. about 6 months from first signed consent form