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Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)

Primary Purpose

Neonatal Abstinence Syndrome, Withdrawal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular acupuncture
Sponsored by
Vanderbilt University Medical Center
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 - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 37 weeks gestational age or greater
  • Maternal age 16 or older
  • Substance exposure in utero including opioids, illicit drugs, or other medications that cause neonatal withdrawal

Exclusion Criteria:

  • Birth trauma
  • Neonatal asphyxia
  • Maternal or neonatal infection
  • Congenital abnormalities
  • Requiring Neonatal Intensive Care Unit (NICU) care

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Auricular acupressure

Arm Description

Outcomes

Primary Outcome Measures

Percent of eligible patients enrolled
Percent of patients prematurely terminating treatment
Percent of participants completing all study assessments
Percent of data collection procedures completed
Percent of missing medical record data

Secondary Outcome Measures

Percent of providers enrolled in 3 day training course for NADA protocol
Percent of providers completing 3 day training course for NADA protocol
Percent of providers completing 3 day training course for NADA protocol: The training course includes a national, standardized curriculum, clinical demonstration and skills lab. Providers are trained in application of acupuncture needles which are placed at the same location as acupressure stickers.
Percent of providers completing clinical competency with NADA protocol
Percent of providers completing clinical competency with NADA protocol: Following the training course providers must submit pictures to the NADA instructor with a clinical log of 40 appropriately placed acupuncture needles in accordance with the NADA protocol. Training includes
Percent of providers receiving NADA certification
Percent of providers receiving NADA certification: Once clinical practice is complete and verified by a NADA trainer, providers will receive a NADA certification
Percent of providers receiving credentialing
Following certification of the providers, competency of acupressure placement on neonates for the specific study protocol will be demonstrated via simulation lab. Providers must perform the acupressure, in accordance with the NADA protocol, on a neonatal manikin, and documentation of the appropriate technique will be completed for credentialing purposes. Providers will submit the NADA certificate, a skills checklist that documents appropriate NADA technique on a neonate manikin, and a neonatal simulation lab certificate for credentialing to perform NADA protocol at VUMC.
Client Satisfaction Questionnaire (CSQ*) Score
On day of discharge, the parent(s) will receive the Client Satisfaction Questionnaire (CSQ8) to assess parental satisfaction of acupuncture as an additional therapy. The CSQ8 is an 8 item measure of client satisfaction with services. Items are questions inquiring about respondents' opinions and conclusions about services they have received. Response options differ from item to item, but all are based on a four-point scale. The overall score is produced by summing all item responses. CSQ-8 version scores range from 8 to 32, with higher values indicating higher satisfaction.
Intervention Appropriateness Measure (IAM) Score
Provider and staff acceptability of acupressure as an additional non-pharmacologic treatment will be measured with the Intervention Appropriateness Measure (IAM). The IAM is a four-item measure of the appropriateness of an intervention. Each item of the score is rated on a five point scale where 1 equals completely disagree and 5 equals completely agree. The total score ranges from 5 to 20, with a higher score indicating a higher level of appropriateness.
Acceptability of Intervention Measure (AIM)
Provider and staff acceptability of acupressure as an additional non-pharmacologic treatment will be measured with the Acceptability of Intervention Measure (AIM). The AIM is a four-item measure of the acceptability of an intervention. Each item of the score is rated on a five point scale where 1 equals completely disagree and 5 equals completely agree. The total score ranges from 5 to 20, with a higher score indicating a higher level of acceptability.
Feasibility of Intervention Measure (FIM)
Provider and staff acceptability of acupressure as an additional non-pharmacologic treatment will be measured with the Feasibility of Intervention Measure (FIM). The FIM is a four-item measure of the feasibility of an intervention. Each item of the score is rated on a five point scale where 1 equals completely disagree and 5 equals completely agree. The total score ranges from 5 to 20, with a higher score indicating a higher level of feasibility.

Full Information

First Posted
June 3, 2019
Last Updated
March 7, 2020
Sponsor
Vanderbilt University Medical Center
Collaborators
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03973801
Brief Title
Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)
Official Title
Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
September 16, 2019 (Actual)
Study Completion Date
September 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Medical University of South Carolina

4. Oversight

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

5. Study Description

Brief Summary
This study will assess the feasibility of implementing auricular acupressure as an additional non-pharmacologic therapy for neonates at risk for developing neonatal abstinence syndrome (NAS) at Monroe Carrell Jr Children's Hospital at Vanderbilt University Medical Center (VUMC).
Detailed Description
NAS is a condition in which newborns experience withdrawal symptoms as a result of in utero exposure to opioids and/or other substances ingested by the mother. The condition has significantly risen over the past 20 years. First line treatments for NAS involve the maximization of non-pharmacologic therapies. NAS management focuses on reducing or eliminating the need for medication management to prevent further developmental complications, promote maternal bonding, and reduce hospital length of stay. Auricular acupuncture has been used for the treatment of addiction and has demonstrated efficacy in the adult population. Current evidence suggests that acupuncture is safe and beneficial for multiple conditions that impact neonatal and pediatric populations including NAS. Acupressure is a less invasive therapy and may serve as an additional non-pharmacological adjunct to ease the severe discomfort of withdrawal in neonates at risk for NAS. This study will assess the feasibility of implementing auricular acupressure as an additional non-pharmacologic therapy for neonates at risk for developing neonatal abstinence syndrome (NAS) at Monroe Carrell Jr Children's Hospital at Vanderbilt University Medical Center (VUMC).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auricular acupressure
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Auricular acupuncture
Intervention Description
National Acupuncture Detoxification Association (NADA) protocol for auricular acupressure will be initiated within 24 hours of delivery and continued until withdrawal symptoms measure 6 or less for 12 hours on the modified Finnegan score and/or the morning of expected discharge as in line with standard of care.
Primary Outcome Measure Information:
Title
Percent of eligible patients enrolled
Time Frame
end of study enrollment (about 12 weeks)
Title
Percent of patients prematurely terminating treatment
Time Frame
hospital discharge (about 48-72 hours after delivery)
Title
Percent of participants completing all study assessments
Time Frame
hospital discharge (about 48-72 hours after delivery)
Title
Percent of data collection procedures completed
Time Frame
hospital discharge (about 48-72 hours after delivery)
Title
Percent of missing medical record data
Time Frame
hospital discharge (about 48-72 hours after delivery)
Secondary Outcome Measure Information:
Title
Percent of providers enrolled in 3 day training course for NADA protocol
Time Frame
Prior to start of study enrollment (May 31, 2019)
Title
Percent of providers completing 3 day training course for NADA protocol
Description
Percent of providers completing 3 day training course for NADA protocol: The training course includes a national, standardized curriculum, clinical demonstration and skills lab. Providers are trained in application of acupuncture needles which are placed at the same location as acupressure stickers.
Time Frame
Day 3 of training
Title
Percent of providers completing clinical competency with NADA protocol
Description
Percent of providers completing clinical competency with NADA protocol: Following the training course providers must submit pictures to the NADA instructor with a clinical log of 40 appropriately placed acupuncture needles in accordance with the NADA protocol. Training includes
Time Frame
Prior to start of study enrollment (May 31, 2019)
Title
Percent of providers receiving NADA certification
Description
Percent of providers receiving NADA certification: Once clinical practice is complete and verified by a NADA trainer, providers will receive a NADA certification
Time Frame
Prior to start of study enrollment (May 31, 2019)
Title
Percent of providers receiving credentialing
Description
Following certification of the providers, competency of acupressure placement on neonates for the specific study protocol will be demonstrated via simulation lab. Providers must perform the acupressure, in accordance with the NADA protocol, on a neonatal manikin, and documentation of the appropriate technique will be completed for credentialing purposes. Providers will submit the NADA certificate, a skills checklist that documents appropriate NADA technique on a neonate manikin, and a neonatal simulation lab certificate for credentialing to perform NADA protocol at VUMC.
Time Frame
Prior to start of study enrollment (May 31, 2019)
Title
Client Satisfaction Questionnaire (CSQ*) Score
Description
On day of discharge, the parent(s) will receive the Client Satisfaction Questionnaire (CSQ8) to assess parental satisfaction of acupuncture as an additional therapy. The CSQ8 is an 8 item measure of client satisfaction with services. Items are questions inquiring about respondents' opinions and conclusions about services they have received. Response options differ from item to item, but all are based on a four-point scale. The overall score is produced by summing all item responses. CSQ-8 version scores range from 8 to 32, with higher values indicating higher satisfaction.
Time Frame
Day of discharge (about 48-72 hours after delivery)
Title
Intervention Appropriateness Measure (IAM) Score
Description
Provider and staff acceptability of acupressure as an additional non-pharmacologic treatment will be measured with the Intervention Appropriateness Measure (IAM). The IAM is a four-item measure of the appropriateness of an intervention. Each item of the score is rated on a five point scale where 1 equals completely disagree and 5 equals completely agree. The total score ranges from 5 to 20, with a higher score indicating a higher level of appropriateness.
Time Frame
Day of hospital discharge of baby (about 48-72 hours after delivery)
Title
Acceptability of Intervention Measure (AIM)
Description
Provider and staff acceptability of acupressure as an additional non-pharmacologic treatment will be measured with the Acceptability of Intervention Measure (AIM). The AIM is a four-item measure of the acceptability of an intervention. Each item of the score is rated on a five point scale where 1 equals completely disagree and 5 equals completely agree. The total score ranges from 5 to 20, with a higher score indicating a higher level of acceptability.
Time Frame
Day of hospital discharge of baby (about 48-72 hours after delivery)
Title
Feasibility of Intervention Measure (FIM)
Description
Provider and staff acceptability of acupressure as an additional non-pharmacologic treatment will be measured with the Feasibility of Intervention Measure (FIM). The FIM is a four-item measure of the feasibility of an intervention. Each item of the score is rated on a five point scale where 1 equals completely disagree and 5 equals completely agree. The total score ranges from 5 to 20, with a higher score indicating a higher level of feasibility.
Time Frame
Day of hospital discharge of baby (about 48-72 hours after delivery)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 37 weeks gestational age or greater Maternal age 16 or older Substance exposure in utero including opioids, illicit drugs, or other medications that cause neonatal withdrawal Exclusion Criteria: Birth trauma Neonatal asphyxia Maternal or neonatal infection Congenital abnormalities Requiring Neonatal Intensive Care Unit (NICU) care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Jackson, MSN
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS)

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