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The goal of this randomized trial is to examine the effectiveness of a Provider Tailored Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the recovery process in children undergoing surgery. Four hospitals and all Healthcare Providers (HCP) in it will be randomized to either a P-TIPS Group, who will receive the newly developed intervention, or a Control Group who will receive a 2-hour seminar on the management of preoperative anxiety and postoperative pain and otherwise will provide standard care. The aims of this study are to:
PRIMARY AIM
1. Determine if P-TIPS is more effective than standard care for preventing high preoperative anxiety among children undergoing anesthesia and surgery. The primary outcome will be observational anxiety in the operating room settings as measured by m-YPAS (modified-Yale Preoperative Anxiety Scale).
SECONDARY AIMS
The proposed clustered randomized trial of four children's hospitals: CHOC Children's (CHOC), Children's Hospital Los Angeles (CHLA), Lucile Packard Children's Hospital at Stanford, The Children's Hospital, Denver. At each hospital approximately 20 anesthesia and nursing health care providers (HCP) will examine the effectiveness of a Provider Tailored Intervention for Perioperative Stress (P-TIPS) aimed at preventing high anxiety and improving the recovery process in children undergoing surgery via modifying adults' behavior. Each hospital and all HCP in it will be randomized to either a P-TIPS Group, who will receive the newly developed intervention, or a Control Group who will receive a 2-hour seminar on the management of preoperative anxiety and postoperative pain and otherwise will provide standard care. Objective measures of children's preoperative anxiety and postoperative recovery, as well as adherence measures of HCP will be collected prior and during the experimental period.
HCP in the Intervention group will learn that the use of behaviors as such distraction and medical reinterpretation directs the child's attention towards more enjoyable topics or reframes the procedure into something less threatening, which in turn diverts the child's attention away from their own distress or fear. Conversely, although HCPs often use reassurance and empathy to help soothe children, the education that HCPs receive from P-TIPS will explain that these emotion-focused comments seem to direct children's attention to their own distress and frightening aspects of the medical procedure. HCPs will also learn the intricacies of implementing these strategies and ways to adjust their behavior to effectively keep children engaged in coping related behaviors.
Child's anxiety m-YPAS during induction is assessed at two points, a) entering the operating room and b) introduction of the anesthesia mask to the child. Once in the OR, the child's blood pressure and heart rate is also assessed. A total of 10 child-parent dyad interactions per HCP are collected for the baseline assessment phase. HCP behavior during induction is also videotaped by research assistants and coded later using the P-CAMPIS measure. Also, parents and children answer baseline questionnaires aimed at capturing demographics, anxiety, health beliefs. Postoperative analgesic consumption, behavioral and recovery measures are also collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P-TIPS group | Experimental | Provider Tailored Intervention for Perioperative Stress (P-TIPS) aims at reducing preoperative anxiety in children via modifying adults' behavior.P-TIPS program is developed from the proximal-distal theory that suggested that in acute procedural settings specific adult behaviors directly affect children's distress and coping behaviors. |
|
| Control Group | No Intervention | Subjects in this group will not be trained with the P-TIPS method. They will receive a 2-hour seminar on the management of preoperative anxiety and postoperative pain and otherwise will provide standard care to patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provider Tailored Intervention for Perioperative Stress | Behavioral | Provider Tailored Intervention for Perioperative Stress (P-TIPS) is developed based on the proximal-distal theory that suggested that in acute procedural settings specific adult behaviors directly affect children's distress and coping behaviors. P-TIPS aims at reducing preoperative anxiety in children via modifying adults' behavior. |
| Measure | Description | Time Frame |
|---|---|---|
| Child's anxiety in the operating room settings. | m-YPAS (modified-Yale Preoperative Anxiety Scale) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the intervention on the child's recovery parameters including emergence delirium, systolic pressure, diastolic pressure, heart rate recordings, and analgesic consumption. | 2 weeks |
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INCLUSION CRITERIA:
Children:
Parents: Parents of children who are enrolled in the study.
Healthcare Provider:
EXCLUSION CRITERIA
Children:
Parents:
Healthcare Providers:
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| Name | Affiliation | Role |
|---|---|---|
| Zeev N. Kain, MD, MBA | UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027-6062 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26895152 | Derived | Stevenson RS, Rosales A, Fortier MA, Campos B, Golianu B, Zuk J, Gold J, Kain ZN. The Role of Ethnicity and Acculturation in Preoperative Distress in Parents of Children Undergoing Surgery. J Immigr Minor Health. 2017 Jun;19(3):738-744. doi: 10.1007/s10903-016-0357-7. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D018730 | Infant Behavior |
| D010146 | Pain |
| D000294 | Adolescent Behavior |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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|
| Menlo Park |
| California |
| 94025-3434 |
| United States |
| CHOC Children's Hospital | Orange | California | 92868 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 30602-7411 | United States |
| Boyd Graduate Studies Research Center | Athens | Georgia | 30602-7411 | United States |
| IWK Health Center | Halifax | Nova Scotia | B3K6R8 | Canada |
| D012816 | Signs and Symptoms |
| D002652 | Child Behavior |
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |