Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624410
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
We Will Compare Anxiety Levels Between English and Spanish-speaking Patients Before Surgery At a Childrens Hospital We Hypothesize That Spanish-speaking Patients Will Experience Greater Anxiety so an Educational Intervention Will Be Introduced One-week Before Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Reduction of Perioperative Anxiety in Spanish-Speaking Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Rationale Pre-operative anxiety is a common phenomenon among children as well as their parents with some studies suggesting it occurs in up to 50 of children who are undergoing surgery in the United States US Therefore the prevalence of this phenomenon within the surgical field represents a solvable problem the elimination of which would be of added benefit to the surgical experience for patients Beyond the simple unpleasantness of experiencing anxiety higher levels of pre-operative anxiety have also been shown to associate with worse post-surgical outcomes including increased pain agitated emergence from anesthesia emergence delirium and maladaptive behavioral change Indeed this means that addressing pre-operative anxiety could lead to better overall health outcomes post-operatively
Demographically the Hispanic Latino population is one of the fastest growing in the US with a predicted increase by 240 by the year 2060 meaning that one in three US residents will be Hispanic at that time Our ever-diversifying US population highlights a need for more personalized and culturally considerate medical care as research has shown that ethnicity culture and language may play a role in decision making as well as the patient experience
Given the association between pre-operative anxiety and worse post-operative outcomes and the fact that Hispanic children with Spanish-speaking parents experience higher levels of pre-operative anxiety as opposed to their white counterparts the investigators have thus identified a gap in healthcare that leaves Hispanic populations vulnerable to preventable health disparities Therefore the purpose of this project is to create an intervention designed specifically for Hispanic Spanish-speaking children that will lower rates of pre-operative anxiety and thus improve their post-operative outcomes
Background To address the problem of pre-operative anxiety in children it was paramount to develop a valid metric for accurately assessing anxiety level To assist with measuring anxiety in children before surgery the modified Yale Preoperative Anxiety Scale mYPAS was developed in 1995 and then modified in 1997 This scale uses 5 items each of which represent a different domain of child anxiety and is used at 4 distinct timepoints throughout the surgical experience However though this metric was reliable and accurate the inclusion of 5 different domains of assessment over 4 timepoints proved to be somewhat redundant and cumbersome to use in a hectic surgical setting Therefore in 2014 Jenkins et al developed a short form version of the mYPAS aptly renamed mYPAS-SF through elimination of areas of redundancy and only administered at 2 time points instead of 4 Use of this metric has helped identify characteristics which may correspond to higher levels of anxiety such as younger age a shyer temperament an established history of surgery and miscellaneous parental factors
Once a reliable metric for assessing pre-operative anxiety in children was established various experimental interventions were developed and introduced to children pre-operatively like listening to calming music or encouragement of participation in recreation beforehand both of which had a significant impact on the reduction of pre-operative anxiety However an inherent problem with these studies is that most of them are conducted on primarily white English-speaking children or their parents which limits their generalizability Indeed research has confirmed that cultural consideration is necessary Hispanic children with Spanish-speaking parents experience higher levels of pre-operative anxiety as compared to white children with English-speaking parents This is not exclusively limited to children but to their parents as well Fortier et al specifically concluded that Spanish-speaking Hispanic parents exhibited higher levels of anxiety and this correlates to higher levels of preoperative anxiety in their children These differences represent a gap in healthcare that could be filled through tailored delivery of interventions pre-operatively which reduce Hispanic childrens anxiety and will correspond to better outcomes post-operatively
Study Design Initially the investigators plan to perform an observational pilot study to identify differences in pre-operative anxiety scores in our patient population between English-speaking patients and Spanish-speaking patients This will not include any sort of intervention only generation of mYPAS scores between two groups of patients The investigators will use the same inclusion and exclusion criteria for this phase with the goal of identifying 20 patients in each arm
The main study to follow our pilot data gathering phase is a single center prospective randomized controlled trial RCT with 11 allocation between 2 parallel arms Blocked randomization will be used to reduce bias reduce the opportunity for confounding and achieve balance between study arms To reduce selection bias random block sizes of 4 and 8 will be used with blinding of the investigator to block size
Intervention arm Home video educational intervention Control arm Standard of care preoperative instructions
The initial observational phase of the study will look at 20 English-speaking children in comparison with 20 Spanish-speaking children and their mYPAS scores This will be to help elucidate any existing difference in baseline anxiety between groups Investigators will then move onto the intervention portion of the study by implementing an educational home video for Spanish-speaking families to watch in preparation for the surgery
For both the observational and intervention portion of the study baseline anxiety will be scored by the mYPAS scoring system with a range of 23-100 as an anxiety score Prior studies noted that a score in the 40s is predictive for worsened anxiety at induction of anesthesia where a score of 60 was associated with extreme anxiety Thus a decrease in anxiety score of 10-15 may be argued as valuable From prior studies investigators have noted about a 30 decrease with their interventions Based on pilot data collected from our DCH patient population investigators have decided on the numbers below to find a similar difference based on power analysis calculations The portion of the study will include 25 subjects in the intervention arm and 25 subjects in the control standard of care arm Investigators will aim to enroll more patients to improve our sample size as able from the Doernbecher hospital on the OHSU campus The investigators predict that 5-10 of patients within the Doernbecher operating room will meet inclusion criteria and assume a 50 enrollment rate to achieve a total enrollment number of around 50 patients
Strategies for Subject Recruitment and Retention Most subject recruitment is expected to occur by approved study staff the week prior to surgery in Doernbecher Childrens Hospital via review of the surgical schedule as posted in Epic Verona Wisconsin The investigators will work with anesthesiology providers and pre-anesthesia nursing staff to identify and screen for potential eligible subjects All inclusionexclusion criteria will be reviewed as early as two weeks prior to a potential subjects scheduled surgery If a potential subject has been identified as meeting all inclusion criteria and none of the exclusion criteria an approved member of the study team will call the potential subjects parent using the approved telephone script to introduce the study included in Consent Form and Recruitment Materials section of application If the subjects parent is amenable to including the subject in the study study staff will provide formal consent materials and obtain signature Spanish-speaking subjects will be consented and enrolled using phone interpretive services
Vulnerable Populations The clinical question is about children so it is impossible to conduct this study without involving children Vulnerable populations including neonates up to 28 days post birth will be excluded Children currently in youth correctional facilities and pregnant pediatric subjects in our age range will be excluded
Setting The study will take place in the pediatric operating suites of OHSU Doernbecher Hospital located in Portland Oregon Verbal consent will be obtained through the telephone during the week preceding surgery All study interventions will occur in the preoperative area the operating rooms or in the post-anesthesia care unit Data collection will continue to occur throughout the patients hospitalization
Consent Process The subject parent consent process will take place over the phone with the research staff in a private and confidential area All subject parents that are approached for recruitment will hear a description of the study reasons for pursuing this research study options for opting out the research protocol or not completing data collection and potential risks advantages and disadvantages from participating Investigators will ask pediatric subjects to reiterate their understanding of how the study will affect their care and allow time for questions If subject age and mental capacity allow assent will be obtained from study subjects A copy of the consent will be mailed electronically to subjects for their medical records
Since this study poses no more than minimal risk and no procedures will be conducted in this study for which written documentation is normally required outside of research verbal consent will be used in lieu of written consent Due to the minimal risk nature of the study permission from one parent or guardian will be sufficient The study team will identify parents who are able to assent based on age and cognitive ability and present all necessary consent information and documentation to them Both parental consent and subject assent will be documented in the HIPAA compliant database After verbal consent has been obtained an informational sheet will be emailed to subject parents The informational sheet will be created in both Spanish and English
Investigators are requesting that verbal consent be used for this study because it is not practical to obtain consent prior to the day of surgery Verbal consent will not adversely affect the rights or welfare of the study subjects Investigators will provide contact information for the principal investigator on the informational sheet and study subjects and their parents will be informed on how to withdrawal without penalty from the study at any time
For study subjects or their parents who are not primary English speakers consent documentation will be communicated verbally over the phone in the subjects native language with 3rd party medical grade interpretation or a certified interpreter from the study team Interpreter services will be used for all study visits
Handling of Data Study subjects will be assigned a unique study number after enrollment in the study All data points procedure related data and electronic files for data analysis will be linked only to this unique study number which will be not include patient identifying information The key linking study subjects to study code will be kept in a cloud location with special protection for confidential and restricted health information the OHSU OneDrive for indefinite use Only the principal investigator and other study staff will have access to this key
Data Analysis The database will be created and managed by Praveen Tekkali a computer scientist within the Clinical Research Division of Anesthesiology and Perioperative Medicine The statistical analysis described herein will be conducted by RDB The research team led by Dr Tomas Lazo will be responsible for interpreting the data
Statistical Analysis The primary endpoints of this study will be pediatric patient preoperative anxiety measured in the pre-operative bay while awaiting surgery with the mYPAS-SF anxiety index Simple descriptive statistics and the student T-test or Mann Whitney test will be used where appropriate All statistical analysis will use intention-to-treat patient population
PowerSample Size This study is powered to detect a 30 percent reduction in preoperative anxiety as measured by the mYPAS-SF anxiety index Our baseline mYPAS-SF anxiety for pediatric patients at Doernbecher is 386 As such investigators plan to enroll 25 subjects in each arm
Privacy Confidentiality and Data Security Verbal consent will be obtained from parents interested in participating over the phone The research team will conduct these phone interviews from closed private offices in Multnomah Pavilion 3rd floor Phone calls be made from OHSU phones using approved OHSU long distance codes The key linking study subjects to study code will be kept in a cloud location with special protection for confidential and restricted health information OHSU OneDrive Only the principal investigator and other study staff will have access to this key
Potential Benefits to Subjects This study is being performed because preoperative anxiety has been linked to worse postoperative outcomes and pediatric non-English speakers have higher levels of preoperative anxiety Patients in the intervention group may experience lower preoperative anxiety and have greater understanding of perioperative anesthesia care
Risks and Benefits Risks to Subjects As with all studies breach of confidentiality is a common risk In addition there is the possibility of slightly increased anxiety or psychological stress on the day of surgery Investigators believe the magnitude and duration of this psychological stress to be small and brief There is also likely to be a loss of free time in the preoperative area due to study procedures
Demographically the Hispanic Latino population is one of the fastest growing in the US with a predicted increase by 240 by the year 2060 meaning that one in three US residents will be Hispanic at that time Our ever-diversifying US population highlights a need for more personalized and culturally considerate medical care as research has shown that ethnicity culture and language may play a role in decision making as well as the patient experience
Given the association between pre-operative anxiety and worse post-operative outcomes and the fact that Hispanic children with Spanish-speaking parents experience higher levels of pre-operative anxiety as opposed to their white counterparts the investigators have thus identified a gap in healthcare that leaves Hispanic populations vulnerable to preventable health disparities Therefore the purpose of this project is to create an intervention designed specifically for Hispanic Spanish-speaking children that will lower rates of pre-operative anxiety and thus improve their post-operative outcomes
Background To address the problem of pre-operative anxiety in children it was paramount to develop a valid metric for accurately assessing anxiety level To assist with measuring anxiety in children before surgery the modified Yale Preoperative Anxiety Scale mYPAS was developed in 1995 and then modified in 1997 This scale uses 5 items each of which represent a different domain of child anxiety and is used at 4 distinct timepoints throughout the surgical experience However though this metric was reliable and accurate the inclusion of 5 different domains of assessment over 4 timepoints proved to be somewhat redundant and cumbersome to use in a hectic surgical setting Therefore in 2014 Jenkins et al developed a short form version of the mYPAS aptly renamed mYPAS-SF through elimination of areas of redundancy and only administered at 2 time points instead of 4 Use of this metric has helped identify characteristics which may correspond to higher levels of anxiety such as younger age a shyer temperament an established history of surgery and miscellaneous parental factors
Once a reliable metric for assessing pre-operative anxiety in children was established various experimental interventions were developed and introduced to children pre-operatively like listening to calming music or encouragement of participation in recreation beforehand both of which had a significant impact on the reduction of pre-operative anxiety However an inherent problem with these studies is that most of them are conducted on primarily white English-speaking children or their parents which limits their generalizability Indeed research has confirmed that cultural consideration is necessary Hispanic children with Spanish-speaking parents experience higher levels of pre-operative anxiety as compared to white children with English-speaking parents This is not exclusively limited to children but to their parents as well Fortier et al specifically concluded that Spanish-speaking Hispanic parents exhibited higher levels of anxiety and this correlates to higher levels of preoperative anxiety in their children These differences represent a gap in healthcare that could be filled through tailored delivery of interventions pre-operatively which reduce Hispanic childrens anxiety and will correspond to better outcomes post-operatively
Study Design Initially the investigators plan to perform an observational pilot study to identify differences in pre-operative anxiety scores in our patient population between English-speaking patients and Spanish-speaking patients This will not include any sort of intervention only generation of mYPAS scores between two groups of patients The investigators will use the same inclusion and exclusion criteria for this phase with the goal of identifying 20 patients in each arm
The main study to follow our pilot data gathering phase is a single center prospective randomized controlled trial RCT with 11 allocation between 2 parallel arms Blocked randomization will be used to reduce bias reduce the opportunity for confounding and achieve balance between study arms To reduce selection bias random block sizes of 4 and 8 will be used with blinding of the investigator to block size
Intervention arm Home video educational intervention Control arm Standard of care preoperative instructions
The initial observational phase of the study will look at 20 English-speaking children in comparison with 20 Spanish-speaking children and their mYPAS scores This will be to help elucidate any existing difference in baseline anxiety between groups Investigators will then move onto the intervention portion of the study by implementing an educational home video for Spanish-speaking families to watch in preparation for the surgery
For both the observational and intervention portion of the study baseline anxiety will be scored by the mYPAS scoring system with a range of 23-100 as an anxiety score Prior studies noted that a score in the 40s is predictive for worsened anxiety at induction of anesthesia where a score of 60 was associated with extreme anxiety Thus a decrease in anxiety score of 10-15 may be argued as valuable From prior studies investigators have noted about a 30 decrease with their interventions Based on pilot data collected from our DCH patient population investigators have decided on the numbers below to find a similar difference based on power analysis calculations The portion of the study will include 25 subjects in the intervention arm and 25 subjects in the control standard of care arm Investigators will aim to enroll more patients to improve our sample size as able from the Doernbecher hospital on the OHSU campus The investigators predict that 5-10 of patients within the Doernbecher operating room will meet inclusion criteria and assume a 50 enrollment rate to achieve a total enrollment number of around 50 patients
Strategies for Subject Recruitment and Retention Most subject recruitment is expected to occur by approved study staff the week prior to surgery in Doernbecher Childrens Hospital via review of the surgical schedule as posted in Epic Verona Wisconsin The investigators will work with anesthesiology providers and pre-anesthesia nursing staff to identify and screen for potential eligible subjects All inclusionexclusion criteria will be reviewed as early as two weeks prior to a potential subjects scheduled surgery If a potential subject has been identified as meeting all inclusion criteria and none of the exclusion criteria an approved member of the study team will call the potential subjects parent using the approved telephone script to introduce the study included in Consent Form and Recruitment Materials section of application If the subjects parent is amenable to including the subject in the study study staff will provide formal consent materials and obtain signature Spanish-speaking subjects will be consented and enrolled using phone interpretive services
Vulnerable Populations The clinical question is about children so it is impossible to conduct this study without involving children Vulnerable populations including neonates up to 28 days post birth will be excluded Children currently in youth correctional facilities and pregnant pediatric subjects in our age range will be excluded
Setting The study will take place in the pediatric operating suites of OHSU Doernbecher Hospital located in Portland Oregon Verbal consent will be obtained through the telephone during the week preceding surgery All study interventions will occur in the preoperative area the operating rooms or in the post-anesthesia care unit Data collection will continue to occur throughout the patients hospitalization
Consent Process The subject parent consent process will take place over the phone with the research staff in a private and confidential area All subject parents that are approached for recruitment will hear a description of the study reasons for pursuing this research study options for opting out the research protocol or not completing data collection and potential risks advantages and disadvantages from participating Investigators will ask pediatric subjects to reiterate their understanding of how the study will affect their care and allow time for questions If subject age and mental capacity allow assent will be obtained from study subjects A copy of the consent will be mailed electronically to subjects for their medical records
Since this study poses no more than minimal risk and no procedures will be conducted in this study for which written documentation is normally required outside of research verbal consent will be used in lieu of written consent Due to the minimal risk nature of the study permission from one parent or guardian will be sufficient The study team will identify parents who are able to assent based on age and cognitive ability and present all necessary consent information and documentation to them Both parental consent and subject assent will be documented in the HIPAA compliant database After verbal consent has been obtained an informational sheet will be emailed to subject parents The informational sheet will be created in both Spanish and English
Investigators are requesting that verbal consent be used for this study because it is not practical to obtain consent prior to the day of surgery Verbal consent will not adversely affect the rights or welfare of the study subjects Investigators will provide contact information for the principal investigator on the informational sheet and study subjects and their parents will be informed on how to withdrawal without penalty from the study at any time
For study subjects or their parents who are not primary English speakers consent documentation will be communicated verbally over the phone in the subjects native language with 3rd party medical grade interpretation or a certified interpreter from the study team Interpreter services will be used for all study visits
Handling of Data Study subjects will be assigned a unique study number after enrollment in the study All data points procedure related data and electronic files for data analysis will be linked only to this unique study number which will be not include patient identifying information The key linking study subjects to study code will be kept in a cloud location with special protection for confidential and restricted health information the OHSU OneDrive for indefinite use Only the principal investigator and other study staff will have access to this key
Data Analysis The database will be created and managed by Praveen Tekkali a computer scientist within the Clinical Research Division of Anesthesiology and Perioperative Medicine The statistical analysis described herein will be conducted by RDB The research team led by Dr Tomas Lazo will be responsible for interpreting the data
Statistical Analysis The primary endpoints of this study will be pediatric patient preoperative anxiety measured in the pre-operative bay while awaiting surgery with the mYPAS-SF anxiety index Simple descriptive statistics and the student T-test or Mann Whitney test will be used where appropriate All statistical analysis will use intention-to-treat patient population
PowerSample Size This study is powered to detect a 30 percent reduction in preoperative anxiety as measured by the mYPAS-SF anxiety index Our baseline mYPAS-SF anxiety for pediatric patients at Doernbecher is 386 As such investigators plan to enroll 25 subjects in each arm
Privacy Confidentiality and Data Security Verbal consent will be obtained from parents interested in participating over the phone The research team will conduct these phone interviews from closed private offices in Multnomah Pavilion 3rd floor Phone calls be made from OHSU phones using approved OHSU long distance codes The key linking study subjects to study code will be kept in a cloud location with special protection for confidential and restricted health information OHSU OneDrive Only the principal investigator and other study staff will have access to this key
Potential Benefits to Subjects This study is being performed because preoperative anxiety has been linked to worse postoperative outcomes and pediatric non-English speakers have higher levels of preoperative anxiety Patients in the intervention group may experience lower preoperative anxiety and have greater understanding of perioperative anesthesia care
Risks and Benefits Risks to Subjects As with all studies breach of confidentiality is a common risk In addition there is the possibility of slightly increased anxiety or psychological stress on the day of surgery Investigators believe the magnitude and duration of this psychological stress to be small and brief There is also likely to be a loss of free time in the preoperative area due to study procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None