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Assessing the Effects of Auricular Acupressure on Newborns With NAS

Primary Purpose

Neonatal Abstinence Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular acupressure
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Abstinence Syndrome focused on measuring acupressure

Eligibility Criteria

undefined - 2 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Auricular acupressure for NAS infants

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2018
Last Updated
April 12, 2021
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03890562
Brief Title
Assessing the Effects of Auricular Acupressure on Newborns With NAS
Official Title
Assessing the Effects of Auricular Acupressure on Newborn Behaviors and Withdrawal Signs in Newborns With Neonatal Abstinence Syndrome: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
March 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome
Keywords
acupressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This feasibility study is a single group longitudinal pretest/posttest design
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auricular acupressure for NAS infants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Auricular acupressure
Intervention Description
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 Measure Information:
Title
Number of participants recruited compared to number actually enrolled
Description
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.
Time Frame
Beginning with IRB approval and ending when last eligible newborn completes the intervention. 6 months from IRB approval
Secondary Outcome Measure Information:
Title
Rate of participant (newborn) study completion
Description
Number of newborns who completed the final study visit compared to total number of signed consent forms signaling that newborns were enrolled the study
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
Other Pre-specified Outcome Measures:
Title
List of behaviors exhibited by newborns with NAS during auricular acupressure intervention
Description
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.
Time Frame
Beginning with first intervention and ending when last eligible newborn completes the intervention. about 6 months from first intervention
Title
The Modified Finnegan Score Scale numbers will decrease following intervention.
Description
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.
Time Frame
changes from baseline through day 11

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Brown, PhD, RN
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23222
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1163358
Citation
Finnegan LP, Connaughton JF Jr, Kron RE, Emich JP. Neonatal abstinence syndrome: assessment and management. Addict Dis. 1975;2(1-2):141-58.
Results Reference
result
Citation
Tyme, L. (2001). Student Manual on the Fundamentals of Traditional Oriental Medicine (4th edition). Living Earth Enterprises, CA.
Results Reference
result
PubMed Identifier
14736587
Citation
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.
Results Reference
result

Learn more about this trial

Assessing the Effects of Auricular Acupressure on Newborns With NAS

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