We Will Compare Anxiety Levels Between English and Spanish-speaking Patients Before Surgery at a Children's Hospital. We Hypothesize That Spanish-speaking Patients Will Experience Greater Anxiety, so an Educational Intervention Will be Introduced One-week Before Surgery.

NCT06624410 | Not Yet Recruiting

• 1 other identifier: STUDY00024545
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this trial is to first evaluate whether a difference exists in anxiety scores between Spanish-speaking children and English-speaking children in the pre-operative setting in our patient population as assessed by the validated myPAS-SF anxiety index. In the interventional phase, the investigators hypothesize that the use of a language-concordant, educational intervention by study participants at home during the week preceding surgery will decrease pre-operative anxiety in Spanish-speaking children, as assessed by the validated mYPAS-SF anxiety index.

Conditions

Anxiety; Healthcare Disparity

Keywords

anxiety; myPAS-SF; healthcare disparity

Outcome Measures

Primary Outcomes (1)

• Anxiety score using the mYPAS-SF anxiety index

  Pre-operative anxiety levels will be assessed with the mYPAS-SF6-12 (below). Subjects will be observed for behaviors and then given a score out of possible 5 across 5 domains that corresponds with demonstrated behaviors, specified in the figure below. The 5 domains include Activity, Vocalization, Emotional Expressivity, State of Arousal, and Use of Parent. Note that the "Vocalization" domain differs in that It's possible scores range from 1-7. Pilot data collection will involve mYPAS scoring in isolation to demonstrate existing anxiety burden at Doernbecher Children's Hospital.

  On average 1-2 weeks. From enrollment to day of surgery.

Secondary Outcomes (3)

• Post-operative/Emergence Delirium

  Up to 24 hours

• VAS pain score

  Up to 1 week

• Morphine equivalents

  Up to 1 week

Other Outcomes (2)

• PACU phase 1 duration

  From day of surgery to end of recovery period in the post-anesthesia care unit

• Total PACU duration

  Up to 1 week.

Study Arms (2)

Control Arm

NO INTERVENTION

Pre-operative anxiety levels will be assessed with the mYPAS-SF6-12 (below). Subjects will be observed for behaviors and then given a score out of possible 5 across 5 domains that corresponds with demonstrated behaviors, specified in the figure below. The 5 domains include Activity, Vocalization, Emotional Expressivity, State of Arousal, and Use of Parent. Note that the "Vocalization" domain differs in that It's possible scores range from 1-7. Pilot data collection will involve mYPAS scoring in isolation to demonstrate existing anxiety burden at Doernbecher Children's Hospital.

Educational Intervention Arm

EXPERIMENTAL

The educational intervention, an informational video to prepare the child for what to expect in the perioperative period, will be delivered within one week of the scheduled surgery assuming parental consent has been confirmed. They will watch the video prior to coming in for surgery and then proceed to have standard care provided as they are assessed for anxiety scores.

Other: Educational Intervention

Interventions

Educational Intervention OTHER

Pre-operative anxiety levels will be assessed with the mYPAS-SF6-12 (below). Subjects will be observed for behaviors and then given a score out of possible 5 across 5 domains that corresponds with demonstrated behaviors, specified in the figure below. The 5 domains include Activity, Vocalization, Emotional Expressivity, State of Arousal, and Use of Parent. Note that the "Vocalization" domain differs in that It's possible scores range from 1-7. Pilot data collection will involve mYPAS scoring in isolation to demonstrate existing anxiety burden at Doernbecher Children's Hospital.

Educational Intervention Arm

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Hispanic/Latino Spanish-Speaking children ages 5-14 years
• Undergoing surgery in the Doernbecher Operating Rooms

You may not qualify if:

• Subjects having cardiac surgery
• Parent refusal of consent
• Children that refuse assent
• Children with psychiatric or atypical neurodevelopmental conditions such as autism or sensory processing disorders that put them at greater risk for pre-surgical anxiety, history of prior surgery, and children with global developmental delay as noted by ICD codes or diagnosis on their problem list
• Impaired decision-making adults
• Incarcerated adults

Sponsors & Collaborators

• Oregon Health and Science University: lead

Related Publications (15)

• Mamtora PH, Kain ZN, Stevenson RS, Golianu B, Zuk J, Gold JI, Fortier MA. An evaluation of preoperative anxiety in Spanish-speaking and Latino children in the United States. Paediatr Anaesth. 2018 Aug;28(8):719-725. doi: 10.1111/pan.13425. Epub 2018 Jul 1.

  PMID: 29962037 BACKGROUND

• Fortier MA, Gomez SH, Kain A. Motivation and parental presence during induction of anesthesia: an examination of the role of ethnicity and language. Paediatr Anaesth. 2012 Nov;22(11):1094-9. doi: 10.1111/j.1460-9592.2012.03841.x.

  PMID: 22458854 BACKGROUND

• Weber FS. The influence of playful activities on children's anxiety during the preoperative period at the outpatient surgical center. J Pediatr (Rio J). 2010 May-Jun;86(3):209-14. doi: 10.2223/JPED.2000. Epub 2010 Apr 23.

  PMID: 20419272 BACKGROUND

• Franzoi MA, Goulart CB, Lara EO, Martins G. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial. Rev Lat Am Enfermagem. 2016 Dec 19;24:e2841. doi: 10.1590/1518-8345.1121.2841.

  PMID: 27992027 BACKGROUND

• Vetter TR. The epidemiology and selective identification of children at risk for preoperative anxiety reactions. Anesth Analg. 1993 Jul;77(1):96-9. doi: 10.1213/00000539-199307000-00019.

  PMID: 8317755 BACKGROUND

• Kain ZN, Mayes LC, Weisman SJ, Hofstadter MB. Social adaptability, cognitive abilities, and other predictors for children's reactions to surgery. J Clin Anesth. 2000 Nov;12(7):549-54. doi: 10.1016/s0952-8180(00)00214-2.

  PMID: 11137417 BACKGROUND

• McCann ME, Kain ZN. The management of preoperative anxiety in children: an update. Anesth Analg. 2001 Jul;93(1):98-105. doi: 10.1097/00000539-200107000-00022. No abstract available.

  PMID: 11429348 BACKGROUND

• Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children. Paediatr Anaesth. 2010 Apr;20(4):318-22. doi: 10.1111/j.1460-9592.2010.03263.x. Epub 2010 Feb 23.

  PMID: 20199609 BACKGROUND

• Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350.

  PMID: 25010821 BACKGROUND

• Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.

  PMID: 9322455 BACKGROUND

• Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.

  PMID: 15562048 BACKGROUND

• Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.

  PMID: 10320165 BACKGROUND

• Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.

  PMID: 17197846 BACKGROUND

• Perry JN, Hooper VD, Masiongale J. Reduction of preoperative anxiety in pediatric surgery patients using age-appropriate teaching interventions. J Perianesth Nurs. 2012 Apr;27(2):69-81. doi: 10.1016/j.jopan.2012.01.003.

  PMID: 22443919 BACKGROUND

• Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.

  PMID: 8953995 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Brandon Togioka, MD

  Oregon Health & Science University

  STUDY CHAIR

Central Study Contacts

Tomas A Lazo, MD

CONTACT

503-346-0264; lazo@ohsu.edu

Sarah Feller, B.S.

CONTACT

503-494-6233

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Anesthesia providers, nurse providers, and surgical providers will be masked. The outcome assessor will be masked. The subject and their parent cannot be masked, due to the nature of the study. We will request of our subjects and parents/guardians to not inform their pre-operative nurse as to their allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 3, 2024
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share