An interventional study of Auricular acupuncture in Neonatal Abstinence Syndrome and Withdrawal, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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).
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).
65 studies on the registry are indexed under Neonatal Abstinence Syndrome; 6 are open to participants now.
This study's enrollment of 12 is below the median of 44 across 50 interventional studies indexed under Neonatal Abstinence Syndrome.
Browse Neonatal Abstinence Syndrome studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Auricular acupuncture
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.
Percent of eligible patients enrolled
Time frame: end of study enrollment (about 12 weeks)
Percent of patients prematurely terminating treatment
Time frame: hospital discharge (about 48-72 hours after delivery)
Percent of participants completing all study assessments
Time frame: hospital discharge (about 48-72 hours after delivery)
Percent of data collection procedures completed
Time frame: hospital discharge (about 48-72 hours after delivery)
Percent of missing medical record data
Time frame: hospital discharge (about 48-72 hours after delivery)
Percent of providers enrolled in 3 day training course for NADA protocol
Time frame: Prior to start of study enrollment (May 31, 2019)
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.
Time frame: Day 3 of training
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
Time frame: Prior to start of study enrollment (May 31, 2019)
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
Time frame: Prior to start of study enrollment (May 31, 2019)
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.
Time frame: Prior to start of study enrollment (May 31, 2019)
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.
Time frame: Day of discharge (about 48-72 hours after delivery)
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.
Time frame: Day of hospital discharge of baby (about 48-72 hours after delivery)
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.
Time frame: Day of hospital discharge of baby (about 48-72 hours after delivery)
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.
Time frame: Day of hospital discharge of baby (about 48-72 hours after delivery)
Plan to share: No
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Vanderbilt University Medical Center