Pain, PostoperativeNCT01878747
Healthcare Provider Behavior and Children's Perioperative Distress
A study testing Provider Tailored Intervention for Perioperative Stress in people with Pain, Postoperative and Infant Behavior, run by University of California, Irvine at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Pain, Postoperative, Infant Behavior
- What is being tested?
- Provider Tailored Intervention for Perioperative Stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,471 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jun 2011to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children:
- Children who are scheduled to undergo outpatient T\&A
- Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study
- Only children who are in the normal range of development will be recruited for this study
- Parents: Parents of children who are enrolled in the study.
- Healthcare Provider:
- Anesthesia care providers in the four study hospitals
- Nurses who provide preoperative nursing care to children who are about to undergo surgery in the four study hospitals
Who cannot join
- Children:
- Patients with health status defined by ASA status IV-V
- Patients who are taking psychotropic medications that affect emotion modulation
- Patients who are taking medications such as erythromycin that interfere with the metabolism of midazolam
- Patients born before 36 weeks gestational age are considered premature and will not be included in this study
- Patients with a positive sleep study and patients who have any indication to be admitted postoperatively (e.g. positive sleep study)
Show all 13Show fewer
- Patients with a positive sleep study indicating sleep apnea will also be excluded from this study.
- Parents:
- Parents who refuse to be part of the study
- Parents who don't speak English if the health care providers involved with that child-parent dyad don't speak the language that is spoken by the parent and child
- Healthcare Providers:
- Anesthesiologists who refuse to be part of the study
- Nurses who refuse to be part of the study
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Boyd Graduate Studies Research Center
Athens, Georgia, 30602-7411
Children's Hospital Colorado
Aurora, Colorado, 30602-7411
Children's Hospital Los Angeles
Los Angeles, California, 90027-6062
Stanford University
Menlo Park, California, 94025-3434
CHOC Children's Hospital
Orange, California, 92868
About this study
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
Read more
- 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
- Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain, recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral changes as measured by the PAED, and PHBQ
- Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires
- Determine if HCP in P-TIPS group display more desired behaviors and less undesired behaviors as compared to control group and whether these behaviors mediate the child and parent-level outcomes.These behaviors will be measured using the m-PCAMPIS
Read the detailed description
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.
- Conditions
- Pain, Postoperative, Infant Behavior
- Being tested
- Provider Tailored Intervention for Perioperative Stress
- Keywords
- Pediatric, Pain, Postoperative, General Anesthesia, Anesthesia Recovery Period, Infant Behavior, Adolescent Behavior, Patient Satisfaction
- Medical subject headings
- Pain, Postoperative, Infant Behavior, Pain, Adolescent Behavior, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Tailored Intervention for Perioperative StressBehavioural
Also called P-TIPS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Provider Tailored Intervention for Perioperative Stress |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's anxiety in the operating room settings.
m-YPAS (modified-Yale Preoperative Anxiety Scale)
Measured: 1 day
Secondary outcomes (1)
Impact of the intervention on the child's recovery parameters including emergence delirium, systolic pressure, diastolic pressure, heart rate recordings, and analgesic consumption.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJun 2011
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- 1,471 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeev Kain, University of California, Irvine
- Investigators
- Zeev N. Kain, MD, MBA, Principal investigator, UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878747
- Sponsor's protocol ID
- UCIANES02
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2013
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26895152
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Provider Behavior and Children's Perioperative Distress
- ClinicalTrials.gov ID
- NCT01878747
- Acronym / sponsor ID
- UCIANES02
- Conditions
- Pain, Postoperative, Infant Behavior
- Keywords
- Pediatric, Pain, Postoperative, General Anesthesia, Anesthesia Recovery Period, Infant Behavior, Adolescent Behavior, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,471 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Jun 2013 (estimated)
- 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.
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
- 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
- Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain, recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral changes as measured by the PAED, and PHBQ
- Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires
- Determine if HCP in P-TIPS group display more desired behaviors and less undesired behaviors as compared to control group and whether these behaviors mediate the child and parent-level outcomes.These behaviors will be measured using the m-PCAMPIS
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-TIPS group | Experimental | Behavioral: Provider Tailored Intervention for Perioperative StressProvider 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. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children who are scheduled to undergo outpatient T\&A
- Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study
- Only children who are in the normal range of development will be recruited for this study
- Parents: Parents of children who are enrolled in the study.
- Anesthesia care providers in the four study hospitals
Key exclusion criteria (13 listed)
- Patients with health status defined by ASA status IV-V
- Patients who are taking psychotropic medications that affect emotion modulation
- Patients who are taking medications such as erythromycin that interfere with the metabolism of midazolam
- Patients born before 36 weeks gestational age are considered premature and will not be included in this study
- Patients with a positive sleep study and patients who have any indication to be admitted postoperatively (e.g. positive sleep 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 |
|---|---|---|
| Provider Tailored Intervention for Perioperative StressAlso: P-TIPSProvider 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. | Behavioural | P-TIPS group |
Primary outcome
Child's anxiety in the operating room settings.
Time frame: 1 day
m-YPAS (modified-Yale Preoperative Anxiety Scale)
1 secondary outcome
Impact of the intervention on the child's recovery parameters including emergence delirium, systolic pressure, diastolic pressure, heart rate recordings, and analgesic consumption.
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Derived from this study: PubMed 26895152Stevenson 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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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. This study is not recruiting at the moment.
Zeev N. Kain, MD, MBA principal investigator
UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Tailored Intervention for Perioperative Stress in people with Pain, Postoperative and Infant Behavior, run by University of California, Irvine at 6 sites in 2 countries.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's anxiety in the operating room settings. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878747, which also lists 1 linked publication.
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 25 Feb 2019.