Pain, PostoperativeNCT06020677
Latinx Children and Surgery
A study testing L-WebTIPS in people with Pain, Postoperative and Pain, Acute, run by University of California, Irvine at 1 site in United States.
Trial summary
Over 60 million persons in the United States (US) identify themselves as Latinx and 25.6% are children under the age of 16. Surgical disparities for adults and children have been identified as a major problem in the US and can be experienced at multiple points along a patient's health care trajectory. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Pain, Acute
- What is being tested?
- L-WebTIPS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children:
- Children age 2-12 who are scheduled to undergo outpatient surgery.
- Children of Latinx parents, who speak Spanish as a primary language and who may speak English
- Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study. ASA status I refers to "patients who are normal and healthy with no known systemic disease". ASA status II refers to "patients who have mild or well-controlled systemic diseases," such as non-insulin dependent diabetes, upper respiratory conditions, well-controlled asthma or allergies. ASA status III refers to patients who have moderate or severe systemic disease, which does limit their activities (e.g., stable angina or diabetes with systemic sequellae). This criteria was chosen as this group of children will typically undergo surgery in an outpatient setting. ASA status IV children will most likely undergo surgery in an inpatient setting and represents a much sicker population of children with different barriers.
- Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents at the time of recruitment. The rationale for excluding patients with developmental delay is that it is unknown whether parents manage their children's postoperative pain differently than in the general population. To generalize the findings to the general population, children with developmental delays will be excluded.
- 1. Latinx Parents of children who are enrolled in the study who speak Spanish as a primary language and who may speak English.
Who cannot join
- Children with health status defined by ASA status IV-V will be excluded from this study. ASA status IV refers to "patients with an incapacitating systemic disease that is a constant threat to life". ASA status V "patients are considered moribund".
- Children whose parents do not identify as Latinx will be excluded from this study.
- Children who are taking psychotropic or pain medications that affect emotion modulation will be excluded from this study because of the potential for confounding effects on pain.
- Children with current malignant or any other disease or pain condition will be excluded as this may impact postoperative pain and thus be a confounding variable.
- Parent:
- Parents who refuse to be part of the study.
- Parents who do not speak Spanish as the primary language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
Haydee Cortes, 818-438-6107, cortesh@hs.uci.edu
About this study
Over 60 million persons in the United States (US) identify themselves as Latinx and 25.6% are children under the age of 16.
Surgical disparities for adults and children have been identified as a major problem in the US and can be experienced at multiple points along a patient's health care trajectory. Data from the investigator's center indicates that a substantial portion of Latinx children who undergo surgery experience high anxiety and postoperative pain as well as postoperative impairments in psychological and physical functioning as compared to White non-Latin children who undergo surgery. Recent growth in use of mobile devices provides us an opportunity to create low-cost mobile health (mHealth) behavioral interventions to reduce this disparity in surgical outcomes.
Read more
In a previous National Institutes of Health (NIH) award, the principal investigator (PI) developed and tested an evidence based mHealth tailored intervention (WebTIPS) that aims to prepare and be a companion of a child and their family during a surgical event. WebTIPS aims to enhance the recovery of the child in several ways such as reducing anxiety and pain and is based on information provision, modeling, and teaching of coping skills. WebTIPS, however, was developed and validated with a population of primarily White non-Latinx English-speaking children and their parents. Unfortunately, it is well established that mHealth interventions are significantly less effective when used with specific ethnic minorities unless they underwent a process of cultural adaptation. Over the past 4-years, the investigators have established multiple academic and community collaborations, conducted extensive participatory research with Latinx stakeholders and used the heuristic framework and a modified ecological validity model to culturally adapt WebTIPS. The culturally adapted intervention is called L-WebTIPS. The overall aim of this application is to reduce surgical disparities in a population of Latinx children undergoing surgery. The first phase of this application (R61) includes web programming of L-WebTIPS, and a feasibly randomized control trial (RCT) to test this intervention. The second phase (R33) includes a multi-center RCT which aims to determine the effectiveness of L-WebTIPS compared to attention control intervention in decreasing postoperative pain, opioids consumption and lowering anxiety in Latinx children undergoing outpatient surgery. Secondary aims of the R33 include examining the impact of L-WebTIPS on home-based clinical recovery parameters such as pain, analgesic requirements, new onset behavioral changes and return to normal daily activity in Latinx children undergoing outpatient surgery. The investigators also plan to determine if the use of L-WebTIPS reduces anxiety and improve experience among the parents of Latinx children undergoing surgery.
Finally, the investigators plan to determine if the use of L-WebTIPS reduces anxiety and enhance experience among the parents of Latinx children undergoing surgery. The investigators submit that using a cultural adaption process for an existing validated intervention will accelerate the process of reducing surgical disparities and bringing an effective intervention to clinical settings and routine use.
- Conditions
- Pain, Postoperative, Pain, Acute
- Being tested
- L-WebTIPS
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-WebTIPSOther
This mobile health application includes cultural adaption and grounding of a previously developed and tested tailored mHealth intervention, WebTIPS. LWebTIPS is a culturally adapted mHealth intervention that is aimed at the child and parent and strives to improve clinical outcomes and patient experience of Latinx children. Tailoring variables include: Simpatia, Religiosity and Familism.
| Study group | Role | What they receive |
|---|---|---|
| L-WebTIPS | Experimental | Not described Receives: Other: L-WebTIPS |
| L-WebINFO | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Anxiety
Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
Measured: Child anxiety before surgery, while in the holding area.
Child Anxiety
Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
Measured: Child anxiety when exiting the holding room and up to the point when the child reaches the operating room (OR) doors.
Child Anxiety
Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
Measured: Child anxiety when child walks into the OR and ends when they are presented with and visually aware of the induction mask.
Child Anxiety
Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
Measured: Child anxiety when the child becomes aware of the mask and ends when they are asleep.
Secondary outcomes (4)
Assess Pediatric Anesthesia Emergence Delirium [Emergence status and Psychometric Evaluation in children]
Emergence status will be assessed through the Pediatric Anesthesia Emergence Delirium Scale (PAED). Items rated on a 5-point rating scale from 0 ("extremely") to 4 ("not at all"). The PAED rating scale consists of five psychometric items ("child makes eye contact with the caregiver", "child's actions are purposeful," "child is aware of the surroundings," "child is restless," "child is inconsolable") for the measurement of Emergence Delirium in children. Items are summed up for a total score that directly increases with the degree of emergence delirium.
Measured: Post surgery while in the post anesthesia care unit
Change in children's pain intensity using the Postoperative Pain Measure (PPPM)
Postoperative pain intensity will be assessed through the 15-item Postoperative Pain Measure (PPPM) in which parents can indicate the presence or absence of each of the 15 behavioral indicators of pain by selecting either "Yes" or "No" for each question. In this scale, "0: Yes" and "1: No." A total score is achieved by summing all 15 items--higher scores suggest greater pain intensity. The questions on this scale are specific to postoperative pain (e.g. Refuse to eat? Eat less than usual?).
Measured: Days 1-14 after surgery, once a day
Parental Preoperative Anxiety using the State Trait Anxiety Inventory (STAI-T)
The Trait section of the questionnaire is administered to parents to assess their self-reported anxiety. Items rated on a 4-point Likert Scale from 1 ("Almost Never") to 4 ("Almost Always"). The score range is 20-80, the higher score indicating greater anxiety.
Measured: Day of surgery
Assess parent satisfaction outcomes using the National Research Council (NRC) Picker satisfaction survey
Parent satisfaction scores will be evaluated through the National Research Council (NRC) Picker satisfaction survey - Outpatient surgery questionnaire. The questions on this survey evaluate satisfaction with the most recent hospital stay (e.g. Did the care providers explain things in a way you could understand?). Each question presents a multiple choice response of either "Yes-definitely, Yes - mostly, Yes-somewhat, and No." For each question, a higher score indicates greater satisfaction with their visit.
Measured: Postoperative, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start23 Aug 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Zeev Kain, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020677
- Sponsor's protocol ID
- 2330
- Other IDs
- R61MH132249-01
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latinx Children and Surgery
- ClinicalTrials.gov ID
- NCT06020677
- Acronym / sponsor ID
- 2330
- Conditions
- Pain, Postoperative, Pain, Acute
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 60 million persons in the United States (US) identify themselves as Latinx and 25.6% are children under the age of 16.
Surgical disparities for adults and children have been identified as a major problem in the US and can be experienced at multiple points along a patient's health care trajectory. Data from the investigator's center indicates that a substantial portion of Latinx children who undergo surgery experience high anxiety and postoperative pain as well as postoperative impairments in psychological and physical functioning as compared to White non-Latin children who undergo surgery. Recent growth in use of mobile devices provides us an opportunity to create low-cost mobile health (mHealth) behavioral interventions to reduce this disparity in surgical outcomes.
In a previous National Institutes of Health (NIH) award, the principal investigator (PI) developed and tested an evidence based mHealth tailored intervention (WebTIPS) that aims to prepare and be a companion of a child and their family during a surgical event. WebTIPS aims to enhance the recovery of the child in several ways such as reducing anxiety and pain and is based on information provision, modeling, and teaching of coping skills. WebTIPS, however, was developed and validated with a population of primarily White non-Latinx English-speaking children and their parents. Unfortunately, it is well established that mHealth interventions are significantly less effective when used with specific ethnic minorities unless they underwent a process of cultural adaptation. Over the past 4-years, the investigators have established multiple academic and community collaborations, conducted extensive participatory research with Latinx stakeholders and used the heuristic framework and a modified ecological validity model to culturally adapt WebTIPS. The culturally adapted intervention is called L-WebTIPS. The overall aim of this application is to reduce surgical disparities in a population of Latinx children undergoing surgery. The first phase of this application (R61) includes web programming of L-WebTIPS, and a feasibly randomized control trial (RCT) to test this intervention. The second phase (R33) includes a multi-center RCT which aims to determine the effectiveness of L-WebTIPS compared to attention control intervention in decreasing postoperative pain, opioids consumption and lowering anxiety in Latinx children undergoing outpatient surgery. Secondary aims of the R33 include examining the impact of L-WebTIPS on home-based clinical recovery parameters such as pain, analgesic requirements, new onset behavioral changes and return to normal daily activity in Latinx children undergoing outpatient surgery. The investigators also plan to determine if the use of L-WebTIPS reduces anxiety and improve experience among the parents of Latinx children undergoing surgery.
Finally, the investigators plan to determine if the use of L-WebTIPS reduces anxiety and enhance experience among the parents of Latinx children undergoing surgery. The investigators submit that using a cultural adaption process for an existing validated intervention will accelerate the process of reducing surgical disparities and bringing an effective intervention to clinical settings and routine use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-WebTIPS | Experimental | Other: L-WebTIPS |
| L-WebINFO | No intervention | – |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children age 2-12 who are scheduled to undergo outpatient surgery.
- Children of Latinx parents, who speak Spanish as a primary language and who may speak English
- Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study. ASA status I refers to "patients who are normal and healthy with no known systemic disease". ASA status II refers to "patients who have mild or well-controlled systemic diseases," such as non-insulin dependent diabetes, upper respiratory conditions, well-controlled asthma or allergies. ASA status III refers to patients who have moderate or severe systemic disease, which does limit their activities (e.g., stable angina or diabetes with systemic sequellae). This criteria was chosen as this group of children will typically undergo surgery in an outpatient setting. ASA status IV children will most likely undergo surgery in an inpatient setting and represents a much sicker population of children with different barriers.
- Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents at the time of recruitment. The rationale for excluding patients with developmental delay is that it is unknown whether parents manage their children's postoperative pain differently than in the general population. To generalize the findings to the general population, children with developmental delays will be excluded.
- 1. Latinx Parents of children who are enrolled in the study who speak Spanish as a primary language and who may speak English.
Key exclusion criteria (7 listed)
- Children with health status defined by ASA status IV-V will be excluded from this study. ASA status IV refers to "patients with an incapacitating systemic disease that is a constant threat to life". ASA status V "patients are considered moribund".
- Children whose parents do not identify as Latinx will be excluded from this study.
- Children who are taking psychotropic or pain medications that affect emotion modulation will be excluded from this study because of the potential for confounding effects on pain.
- Children with current malignant or any other disease or pain condition will be excluded as this may impact postoperative pain and thus be a confounding variable.
- Parents who refuse to be part of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-WebTIPSThis mobile health application includes cultural adaption and grounding of a previously developed and tested tailored mHealth intervention, WebTIPS. LWebTIPS is a culturally adapted mHealth intervention that is aimed at the child and parent and strives to improve clinical outcomes and patient experience of Latinx children. Tailoring variables include: Simpatia, Religiosity and Familism. | Other | L-WebTIPS |
Primary outcome
Child Anxiety
Time frame: Child anxiety before surgery, while in the holding area.
Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
Child Anxiety
Time frame: Child anxiety when exiting the holding room and up to the point when the child reaches the operating room (OR) doors.
Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
Child Anxiety
Time frame: Child anxiety when child walks into the OR and ends when they are presented with and visually aware of the induction mask.
Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
Child Anxiety
Time frame: Child anxiety when the child becomes aware of the mask and ends when they are asleep.
Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
4 secondary outcomes
Assess Pediatric Anesthesia Emergence Delirium [Emergence status and Psychometric Evaluation in children]
Time frame: Post surgery while in the post anesthesia care unit
Change in children's pain intensity using the Postoperative Pain Measure (PPPM)
Time frame: Days 1-14 after surgery, once a day
Parental Preoperative Anxiety using the State Trait Anxiety Inventory (STAI-T)
Time frame: Day of surgery
Assess parent satisfaction outcomes using the National Research Council (NRC) Picker satisfaction survey
Time frame: Postoperative, day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-WebTIPS in people with Pain, Postoperative and Pain, Acute, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haydee Cortes, BA (7144562838, cortesh@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Anxiety (time frame: Child anxiety before surgery, while in the holding area.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.