Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac Intensive Care Unit (PCICU) of Monroe Carrell Jr Children's Hospital at Vanderbilt (MCJCHV). The investigators will recruit 40 healthy, 34 weeks gestational age or older infants exposed to prolonged medications (greater than 5 days) for cardiac procedures that may cause withdrawal upon cessation such as opioids, benzodiazepines, or other sedative medications. Participants will receive the auricular acupressure in addition to the standard of care such as clustered nursing care, touch, position change, environmental controls, holding, and swaddling.
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac Intensive Care Unit (PCICU) of Monroe Carrell Jr Children's Hospital at Vanderbilt (MCJCHV). The investigators will recruit 40 healthy, 34 weeks gestational age or older infants exposed to prolonged medications (greater than 5 days) for cardiac procedures that may cause withdrawal upon cessation such as opioids, benzodiazepines, or other sedative medications. Participants will receive the auricular acupressure in addition to the standard of care such as clustered nursing care, touch, position change, environmental controls, holding, and swaddling. Within 24 hours of implementing a weaning protocol, acupressure will be applied to three designated points of one ear following the NADA protocol acupuncture technique while also incorporating the Near-Term Infant (NTI) conceptual framework identified elements (see figure 3). Acupressure will be administered via stickers that are adhesive to the skin like a Band-Aid (see figure 1). These stickers include a vaccaria plant seed in the center that applies continuous light pressure on the designated points. This form of acupressure was selected as it is organic and does not contain metal which may interfere with emergency medical care such as imaging. After the initial 24 hours of application, stickers will be removed, the infant's skin will be assessed for any disruption such as bruising or discoloration, and the stickers will be rotated to the infant's other ear at the same NADA protocol auricular sites. Acupressure stickers will be removed and applied to the opposite ear every 48 hours until withdrawal symptoms improve (1). Withdrawal symptoms are measured every 6 hours with the enhanced Withdrawal Assessment tool (WAT) as part of the standard of care. Upon completion of the weaning regimen, infants with a score of less than or equal to 3 or less than 2 above baseline with no more than 2 rescue medication doses in 24 hours will have the acupressure removed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. |
|
| No Intervention | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure | Other | Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. Application will occur at designated points including Shen Men, Liver, and Lung: in the room with the mother; and potentially during breast feeding, holding, skin to skin contact or bottle feeds. Stickers will remain in place for 24 hours. At 24 hours, skin will be assessed, and stickers will then be rotated to the opposite ear every 48 - 72 hours if there are no adverse effects such as skin irritation. |
| Measure | Description | Time Frame |
|---|---|---|
| Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1) | The Withdrawal Assessment Tool- Version 1 (WAT-1) monitors opioid and benzodiazepine withdrawal symptoms in pediatric patients. A total of 19 withdrawal symptoms are rated where 0 indicates no symptoms and 10 is worst possible score in indicating intensity of withdrawal. | Baseline to 72 hours |
| Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU) | Prevalence of Delirium will be reported using the preschool confusion assessment method for the ICU (psCAM-ICU). The psCAM-ICU is designed to assess for presence of delirium in critically ill children with or without mechanical ventilation. The psCAM-ICU was designed with cognitive testing that is developmentally appropriate for infants-5 years. Presence of Delirium is assessed using: 1) Acute change or fluctuating course of mental status, 2) Inattention, 3) Altered level of consciousness, 4) disorganized thinking. Presence of number 1) AND number 2) AND either number 3) OR number 4) indicates delirium is present. The following is how the data was coded: '1' for present and '2' for absent. | Baseline to 72 hours |
| Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS) | RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The primary outcome was median change in RASS score between baseline (immediately before randomized intervention or standard of care) and 72 hours later. | Baseline to 72 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Heather Jackson, MSN, APRN | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Schwartz L, Xiao R, Brown E, Sommers E. Auricular acupressure augmentation of standard medical management of the neonatal narcotic abstinence syndrome. Medical Acupuncture. 2011;23(3):175-86. | ||
| 30234674 | Background | Amirnovin R, Sanchez-Pinto LN, Okuhara C, Lieu P, Koh JY, Rodgers JW, Nelson LP. Implementation of a Risk-Stratified Opioid and Benzodiazepine Weaning Protocol in a Pediatric Cardiac ICU. Pediatr Crit Care Med. 2018 Nov;19(11):1024-1032. doi: 10.1097/PCC.0000000000001719. | |
| 28734732 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acupressure Intervention Group | Per protocol, acupressure provided. |
| FG001 | Control Group | Per protocol, control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
11 participants excluded per protocol and not included in analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. Acupressure: Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. Application will occur at designated points including Shen Men, Liver, and Lung: in the room with the mother; and potentially during breast feeding, holding, skin to skin contact or bottle feeds. Stickers will remain in place for 24 hours. At 24 hours, skin will be assessed, and stickers will then be rotated to the opposite ear every 48 - 72 hours if there are no adverse effects such as skin irritation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1) | The Withdrawal Assessment Tool- Version 1 (WAT-1) monitors opioid and benzodiazepine withdrawal symptoms in pediatric patients. A total of 19 withdrawal symptoms are rated where 0 indicates no symptoms and 10 is worst possible score in indicating intensity of withdrawal. | Posted | Median | Inter-Quartile Range | Score on a scale | Baseline to 72 hours |
|
Adverse events were collected from baseline to 72 hours post intervention per the protocol
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. There was one adverse event recorded in one participant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupressure Intervention Group | Per protocol, acupressure provided. | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin irritation | Skin and subcutaneous tissue disorders | skin irritation | Systematic Assessment | skin irritation |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krista Vermillion | Vanderbilt University Medical Center | 615-875-1921 | krista.k.vermillion@vumc.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2022 | Jun 16, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 23, 2022 | Jun 16, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Infants will be randomized in a 1:1 ratio to two groups - intervention vs. no intervention.
Not provided
Not provided
Participants are electronically randomized in the REDCap database.
Not provided
|
| Background |
| McPherson C, Inder T. Perinatal and neonatal use of sedation and analgesia. Semin Fetal Neonatal Med. 2017 Oct;22(5):314-320. doi: 10.1016/j.siny.2017.07.007. Epub 2017 Jul 19. |
| 26337372 | Background | Weber F, Van Beek S, Scoones G. Potential neurotoxicity of anesthetic drugs in young children: who cares? A survey among European anesthetists. Minerva Anestesiol. 2016 Mar;82(3):294-300. Epub 2015 Sep 3. |
| 26643428 | Background | Chen X, Wan Y, Wen K, Liang T, Lin T, Li P. [Perioperative anesthetic exposure and the neurodevelopmental status of 1 year old baby underwent neonatal cardiac surgery]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2015 Nov;40(11):1234-8. doi: 10.11817/j.issn.1672-7347.2015.11.012. Chinese. |
| 28607205 | Background | Mebius MJ, Kooi EMW, Bilardo CM, Bos AF. Brain Injury and Neurodevelopmental Outcome in Congenital Heart Disease: A Systematic Review. Pediatrics. 2017 Jul;140(1):e20164055. doi: 10.1542/peds.2016-4055. Epub 2017 Jun 13. |
| 32365412 | Background | Barnett AM, Machovec KA, Ames WA, Homi HM, Turi JL, Koo J, Fuller M, Jooste EH. The effect of intraoperative methadone during pediatric cardiac surgery on postoperative opioid requirements. Paediatr Anaesth. 2020 Jul;30(7):773-779. doi: 10.1111/pan.13903. Epub 2020 Jun 25. |
| 22791093 | Background | Gupta P, Whiteside W, Sabati A, Tesoro TM, Gossett JM, Tobias JD, Roth SJ. Safety and efficacy of prolonged dexmedetomidine use in critically ill children with heart disease*. Pediatr Crit Care Med. 2012 Nov;13(6):660-6. doi: 10.1097/PCC.0b013e318253c7f1. |
| 27636695 | Background | Edwards L, Brown LF. Nonpharmacologic Management of Neonatal Abstinence Syndrome: An Integrative Review. Neonatal Netw. 2016;35(5):305-13. doi: 10.1891/0730-0832.35.5.305. |
| 25062522 | Background | Maguire D. Care of the infant with neonatal abstinence syndrome: strength of the evidence. J Perinat Neonatal Nurs. 2014 Jul-Sep;28(3):204-11; quiz E3-4. doi: 10.1097/JPN.0000000000000042. |
| 29414848 | Background | Stuyt EB, Voyles CA, Bursac S. NADA Protocol for Behavioral Health. Putting Tools in the Hands of Behavioral Health Providers: The Case for Auricular Detoxification Specialists. Medicines (Basel). 2018 Feb 7;5(1):20. doi: 10.3390/medicines5010020. |
| Background | Association NAD. Acupuncture Detoxification Specialist Training and Resource Manual. Fourth ed: NADA Literature Clearinghouse; 2015. 203 p. |
| 23230968 | Background | Bergdahl L, Berman AH, Haglund K. Patients' experience of auricular acupuncture during protracted withdrawal. J Psychiatr Ment Health Nurs. 2014 Mar;21(2):163-9. doi: 10.1111/jpm.12028. Epub 2012 Dec 12. |
| 20959312 | Background | Landgren K, Kvorning N, Hallstrom I. Acupuncture reduces crying in infants with infantile colic: a randomised, controlled, blind clinical study. Acupunct Med. 2010 Dec;28(4):174-9. doi: 10.1136/aim.2010.002394. Epub 2010 Oct 18. |
| 22141917 | Background | Gentry KR, McGinn KL, Kundu A, Lynn AM. Acupuncture therapy for infants: a preliminary report on reasons for consultation, feasibility, and tolerability. Paediatr Anaesth. 2012 Jul;22(7):690-5. doi: 10.1111/j.1460-9592.2011.03743.x. Epub 2011 Dec 6. |
| 25875844 | Background | Nager AL, Kobylecka M, Pham PK, Johnson L, Gold JI. Effects of acupuncture on pain and inflammation in pediatric emergency department patients with acute appendicitis: a pilot study. J Altern Complement Med. 2015 May;21(5):269-72. doi: 10.1089/acm.2015.0024. Epub 2015 Apr 15. |
| 30247457 | Background | Tsai SL, Reynoso E, Shin DW, Tsung JW. Acupuncture as a Nonpharmacologic Treatment for Pain in a Pediatric Emergency Department. Pediatr Emerg Care. 2021 Jul 1;37(7):e360-e366. doi: 10.1097/PEC.0000000000001619. |
| 25950453 | Background | Yang C, Hao Z, Zhang LL, Guo Q. Efficacy and safety of acupuncture in children: an overview of systematic reviews. Pediatr Res. 2015 Aug;78(2):112-9. doi: 10.1038/pr.2015.91. Epub 2015 May 7. |
| 26242287 | Background | Abbasoglu A, Cabioglu MT, Tugcu AU, Ince DA, Tekindal MA, Ecevit A, Tarcan A. Acupressure at BL60 and K3 Points Before Heel Lancing in Preterm Infants. Explore (NY). 2015 Sep-Oct;11(5):363-6. doi: 10.1016/j.explore.2015.07.005. Epub 2015 Jul 3. |
| 28741805 | Background | Chen KL, Lindrea KB, Quah-Smith I, Schmolzer GM, Daly M, Schindler T, Oei JL. Magnetic noninvasive acupuncture for infant comfort (MAGNIFIC) - a single-blinded randomised controlled pilot trial. Acta Paediatr. 2017 Nov;106(11):1780-1786. doi: 10.1111/apa.14002. Epub 2017 Aug 29. |
| 18416793 | Background | Chen LL, Su YC, Su CH, Lin HC, Kuo HW. Acupressure and meridian massage: combined effects on increasing body weight in premature infants. J Clin Nurs. 2008 May;17(9):1174-81. doi: 10.1111/j.1365-2702.2007.02147.x. |
| 22462236 | Background | Ecevit A, Ince DA, Tarcan A, Cabioglu MT, Kurt A. Acupuncture in preterm babies during minor painful procedures. J Tradit Chin Med. 2011 Dec;31(4):308-10. doi: 10.1016/s0254-6272(12)60009-0. |
| 24078899 | Background | Filippelli AC, White LF, Spellman LW, Broderick M, Highfield ES, Sommers E, Gardiner P. Non-Insertive Acupuncture and Neonatal Abstinence Syndrome: A Case Series from an Inner City Safety Net Hospital. Glob Adv Health Med. 2012 Sep;1(4):48-52. doi: 10.7453/gahmj.2012.1.4.007. |
| 26504123 | Background | Raith W, Schmolzer GM, Resch B, Reiterer F, Avian A, Koestenberger M, Urlesberger B. Laser Acupuncture for Neonatal Abstinence Syndrome: A Randomized Controlled Trial. Pediatrics. 2015 Nov;136(5):876-84. doi: 10.1542/peds.2015-0676. |
| 25303949 | Background | Raith W, Urlesberger B. Laser acupuncture as an adjuvant therapy for a neonate with neonatal abstinence syndrome (NAS) due to maternal substitution therapy: additional value of acupuncture. Acupunct Med. 2014 Dec;32(6):523-4. doi: 10.1136/acupmed-2014-010638. Epub 2014 Oct 10. No abstract available. |
| 31031873 | Background | Jackson HJ, Lopez C, Miller S, Engelhardt B. A Scoping Review of Acupuncture as a Potential Intervention for Neonatal Abstinence Syndrome. Med Acupunct. 2019 Apr 1;31(2):69-84. doi: 10.1089/acu.2018.1323. Epub 2019 Apr 19. |
| 31140978 | Background | Jackson HJ, Lopez C, Miller S, Englehardt B. Neonatal Abstinence Syndrome: An Integrative Review of Neonatal Acupuncture to Inform a Protocol for Adjunctive Treatment. Adv Neonatal Care. 2019 Jun;19(3):165-178. doi: 10.1097/ANC.0000000000000630. |
| 32635829 | Background | Jackson HJ, Lopez C, Miller S, Englehardt B. Feasibility of auricular acupressure as an adjunct treatment for neonatal opioid withdrawal syndrome (NOWS). Subst Abus. 2021;42(3):348-357. doi: 10.1080/08897077.2020.1784360. Epub 2020 Jul 7. |
| 31110855 | Background | Whelan KT, Heckmann MK, Lincoln PA, Hamilton SM. Pediatric Withdrawal Identification and Management. J Pediatr Intensive Care. 2015 Jun;4(2):73-78. doi: 10.1055/s-0035-1556749. |
| BG001 | No Intervention | No intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU) | Prevalence of Delirium will be reported using the preschool confusion assessment method for the ICU (psCAM-ICU). The psCAM-ICU is designed to assess for presence of delirium in critically ill children with or without mechanical ventilation. The psCAM-ICU was designed with cognitive testing that is developmentally appropriate for infants-5 years. Presence of Delirium is assessed using: 1) Acute change or fluctuating course of mental status, 2) Inattention, 3) Altered level of consciousness, 4) disorganized thinking. Presence of number 1) AND number 2) AND either number 3) OR number 4) indicates delirium is present. The following is how the data was coded: '1' for present and '2' for absent. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline to 72 hours |
|
|
|
| Primary | Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS) | RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The primary outcome was median change in RASS score between baseline (immediately before randomized intervention or standard of care) and 72 hours later. | Posted | Median | Inter-Quartile Range | score in a scale | Baseline to 72 hours |
|
|
|
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Control Group | Per protocol, control group. | 0 | 20 | 0 | 20 | 0 | 20 |
|
Not provided
Not provided
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |