Separation AnxietyNCT04950088
Reduction of Perioperative Anxiety Using a Hand-held Video Game Device
A study testing Hand-held video game device in people with Separation Anxiety and Anxiety, run by Prisma Health-Upstate.
Trial summary
Distraction techniques, such as use of a virtual reality device, have been used to augment or replace pharmacological practices for relief of anxiety in pediatric patients prior to surgical procedures. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Separation Anxiety, Anxiety, Anxiety, Separation
- What is being tested?
- Hand-held video game device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Oct 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- outpatient pediatric surgery patients between July 2016 and October 2016.
- Children, (ages 3-10 years) undergoing low-risk outpatient surgical procedures, including, but not limited to, tonsillectomies, adenoidectomies, etc., for which a masked induction was planned
- guardians of the children had to be present and consent.
Who cannot join
- patients undergoing ear tube placement/removal (due to the short duration of the procedure)
- patients requiring premedication
- patients with physical or mental disabilities rendering it difficult to use the distraction device
- non-English speaking caregivers (due to the language barriers during the post-operative phone calls).
- patients without guardians providing consent
About this study
Distraction techniques, such as use of a virtual reality device, have been used to augment or replace pharmacological practices for relief of anxiety in pediatric patients prior to surgical procedures. This relief can not only benefit medical staff, as procedures may be easier to perform and require less time, but also have a calming effect on the the parent during the procedure if they feel that their child is being better cared for. In addition, decreased anxiety prior to surgical procedures have been shown to reduce maladaptive behaviors post-operatively. This prospective study plans to evaluate the anxiety level of parents and pediatric patients in an outpatient surgery center pre-, during and post-operatively with and without the use of a virtual reality distraction device. The goal is to determine the existence of correlations between distraction techniques (in this case, the use of handheld video games) pediatric patient anxiety, parental anxiety, and parental satisfaction with the experience surrounding the procedure.
Read the detailed description
General Data will be collected for patients being treated at Patewood Outpatient Surgery Center following legal guardian consent. Patients receiving surgical treatment involving the use of an anesthesia mask, age 4 to 10, will be included in the study. Exclusion criteria will include ear tube cases, patients physically incapable to play a video game, patients of non-English speaking caregivers, and patients without legal guardian present day of surgery. IV Ear tube cases are too short a procedure for data collection and at least one caretaker must be capable of taking both an oral and written survey.
For the purposes of this study, a "caregiver" will be defined as an adult that spends a significant amount of time with the patient, and meets the following criteria.
The primary caregiver is the adult that is responsible for the minor patients' care. The caregiver may reside with the patient full-time or part-time but have the information necessary to assess the child's behavior before and after the outpatient procedure.
Data collected for each patient will include demographics, random placement in Video Game/No Video game group, surgical procedure, information normally recorded by surgeon or anesthesiologist including duration of surgery and duration under anesthesia, caregiver reported changes in patient behavior following surgery, and scores of the anxiety being felt by caregivers and patients. Anxiety scores will be determined using shortened versions of validated anxiety scoring assessments. Behavioral changes will be recorded using a shortened version of the Post Hospital Behavior Questionnaire (PHBQ). Assessments have been shortened to increase study participation, and eliminate any impact the study may have had on day-to-day operations at Patewood Outpatient Surgery Center.
Caregivers will also be asked to fill out a hospital created survey related to how satisfied they are with the care of the patient. It will be referred to as the Preoperative Hospital Satisfaction Survey (PHSS). This survey will be administered while the surgical procedure is in progress, when the caregivers are sitting in the waiting room. The survey is to be a reflection of how caregivers perceive preoperative separation care given to patients, so will not be influenced by surgical outcome.
Consent Legal guardians of patients are contacted over the phone by Patewood Outpatient Surgery Center registration per standard preoperative care procedure. Before concluding the normal preoperative interview, a script will be read that introduces the guardian to the study and its goals. The guardian will then be asked if they are interested in learning more about the study. Those who answer "no" will be removed from a list of potential participants. Those who answer "yes" or "maybe" will be given more information about study participation after arriving at the outpatient surgery center on the day of their scheduled appointment. A more thorough explanation of the study will be given and any questions answered. If a guardian is interested in participating, they will be provided a consent form to fill out.
Group assignment Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day.
Assessment and Survey Descriptions
Modified Yale Preoperative Scale (mYPAS)- Observational survey used to quickly score the anxiety level of children during preoperative holding and induction of anesthesia. It has frequent use and validation as an accurate tool for determining the anxiety level of pediatric surgical patients. Each section has 4 to 6 numbers listed, each corresponding with different patient description. For each section, the number by the most accurate patient description is circled. (Jenkins)(Kain)
State Trait Anxiety Inventory (STAI)- Self-taken survey for adults. Gives 2 different scores. One score is an indicator of susceptibility to stressful situations, the other score is the level of anxiety felt while taking the survey. It has frequent use and validation as a tool for determining anxiety levels of adults. (Spielberger)
Post Hospital Behavior Questionnaire (PHBQ)- Survey taken by primary caregiver of a patient after leaving the hospital. The survey is designed to identify maladaptive behaviors a patient has developed following a time at a hospital. Questions must be answered "much less than before", "less than before", "same as before", "more than before", or "much more than before". This survey is sensitive only to the change in frequency of behaviors, not their presence or absence. Therefore, undesirable behavior existing prior to a hospital stay should have no influence on the PHBQ score.
All surveys used in this study were truncated. Any modification was evaluated and approved by the staff psychologist (PhD.) familiar with using surveys to research anxiety and stress of patients and their families. Any questions that were included or excluded from the surveys was done so under expert direction.
Perioperative Holding After completing standard preoperative procedure, a nurse will complete a short observational survey (mYPAS [modified Yale Preoperative Scale] or mYPAS-SF) to score the patients current anxiety level. Just prior to separation from the caregiver, the patient will be given (or not given) a Video Game by the nurse. During separation, another mYPAS will be scored.
Operating Room Another mYPAS will be scored during the induction of anesthesia. If the patient has a video game, the patient is allowed to play as long as he/she wants. Often times, this is up until the procedure begins.
Caregivers During Procedure One or two primary caregivers will be asked to fill out a shortened STAI (State Trait Anxiety Inventory) and PHSS.
Follow-up Phone Calls The day following surgery, standard postoperative care procedure will be followed. This includes a phone call to the caregiver of a patient. Before concluding the phone call, the instructions at the top of the shortened PHBQ will be read to the caregivers participating in the survey. Then each question will be read and answered. One week and 2 weeks following surgery, the caregiver will be called and the shortened PHBQ will be administered.
Statistics The existence of correlations between maladaptive behavior, patient anxiety, caregiver susceptibility to anxiety, caregiver experience of anxiety, caregiver satisfaction, video game use, and any other collected data will be determined. All information from this study will be used to describe our cohort only. All data will be expressed in summary and is meant to contribute to the generalizable knowledge of the field.
- Conditions
- Separation Anxiety, Anxiety, Anxiety, Separation, Anxiety Generalized
- Being tested
- Hand-held video game device
- Keywords
- anxiety, separation fear
- Medical subject headings
- Anxiety, Separation, Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-held video game deviceOther
| Study group | Role | What they receive |
|---|---|---|
| Game | Active comparator | Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day. Receives: Other: Hand-held video game device |
| no game | Active comparator | Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day. Receives: Other: Hand-held video game device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pediatric anxiety score
The modified Yale Preoperative Anxiety Scale16 (mYPAS): evaluated changes in pediatric anxiety with higher anxiety=higher score. mYPAS completed by nurses during initial preoperative evaluation, upon patient separation from parent and at mask induction. All three surveys were identical.
- Activity scored 1-4; B. Vocalizations scored 1-6; C. Emotional expressivity scored 1-4; D. State of apparent arousal scored 1-4
Measured: at three timepoints in the peri-operative suite prior to induction for surgery
Change in parent anxiety score
The Strait-Trait Anxiety Inventory (STAI)17 assessed self-reported parental anxiety (below). The STAI was completed by the parent immediately after separation in the waiting room. STAI consists of two parts: A= perceived anxiety during the child's perioperative period; B= the parent's general state of anxiety. Differences between these two metrics were used to indicate parental satisfaction with their experience.
The A questions were evaluated with the following scale (1-4) utilizing the descriptors
'Not at all' 'Somewhat' 'Moderately So' 'Very Much So' in response to 7 statements.
The B section regarding generalized anxiety was measured as follows (1-4) utilizing the descriptors
'Not at all' 'Somewhat' 'Moderately So' 'Very Much So' in response to 7 statements different from the A section.
The final question is as follows (Y/N):
- The experience of separation from my child for this procedure was better than expected. Y N
Measured: Immediately following separation from the child; change in anxiety from baseline
Overall Parental Satisfaction with the pre-operative process, particularly regarding parent/child separation
To evaluate overall satisfaction of parents with the pre-operative process specifically, a final question was added to the STAI which inquired if the parent/guardian thought that the experience of separation was better or worse than was expected. This question was scored independently.
Measured: Immediately following separation from the child
Change in post-operative behavior as assessed by the parent
The PHBQ queried change in perceived patient's behavior before and after the procedure with an inquiry regarding new-onset negative behaviors manifesting post-surgery. Three attempts were made to gather survey information for each time-point; if a parent could not be reached, data collection for that patient was truncated. Each of the three follow-up calls were completed utilizing the same protocol. The protocol consisted of 10 questions regarding the child's behavior with parent answers utilizing the following scale:
much less less same more much more
The final question was a rank from 1-10 with 10 being the worst (highest) score:
- On a scale from 1 to 10, 1 being no pain and 10 being more pain, how would you rate your child's current pain level?
1 2 3 4 5 6 7 8 9 10
Measured: 24-48 hours, 7 days and 14 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study startJul 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Separation AnxietyStudies 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
- Model description
- Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950088
- Sponsor's protocol ID
- Pro00057182
- Status last verified
- Jun 2021
- First submitted
- 22 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Perioperative Anxiety Using a Hand-held Video Game Device
- ClinicalTrials.gov ID
- NCT04950088
- Acronym / sponsor ID
- Pro00057182
- Conditions
- Separation Anxiety, Anxiety, Anxiety, Separation, Anxiety Generalized
- Keywords
- anxiety, separation fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Jul 2021 (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.
Distraction techniques, such as use of a virtual reality device, have been used to augment or replace pharmacological practices for relief of anxiety in pediatric patients prior to surgical procedures. This relief can not only benefit medical staff, as procedures may be easier to perform and require less time, but also have a calming effect on the the parent during the procedure if they feel that their child is being better cared for. In addition, decreased anxiety prior to surgical procedures have been shown to reduce maladaptive behaviors post-operatively. This prospective study plans to evaluate the anxiety level of parents and pediatric patients in an outpatient surgery center pre-, during and post-operatively with and without the use of a virtual reality distraction device. The goal is to determine the existence of correlations between distraction techniques (in this case, the use of handheld video games) pediatric patient anxiety, parental anxiety, and parental satisfaction with the experience surrounding the procedure.
Detailed description
General Data will be collected for patients being treated at Patewood Outpatient Surgery Center following legal guardian consent. Patients receiving surgical treatment involving the use of an anesthesia mask, age 4 to 10, will be included in the study. Exclusion criteria will include ear tube cases, patients physically incapable to play a video game, patients of non-English speaking caregivers, and patients without legal guardian present day of surgery. IV Ear tube cases are too short a procedure for data collection and at least one caretaker must be capable of taking both an oral and written survey.
For the purposes of this study, a "caregiver" will be defined as an adult that spends a significant amount of time with the patient, and meets the following criteria.
The primary caregiver is the adult that is responsible for the minor patients' care. The caregiver may reside with the patient full-time or part-time but have the information necessary to assess the child's behavior before and after the outpatient procedure.
Data collected for each patient will include demographics, random placement in Video Game/No Video game group, surgical procedure, information normally recorded by surgeon or anesthesiologist including duration of surgery and duration under anesthesia, caregiver reported changes in patient behavior following surgery, and scores of the anxiety being felt by caregivers and patients. Anxiety scores will be determined using shortened versions of validated anxiety scoring assessments. Behavioral changes will be recorded using a shortened version of the Post Hospital Behavior Questionnaire (PHBQ). Assessments have been shortened to increase study participation, and eliminate any impact the study may have had on day-to-day operations at Patewood Outpatient Surgery Center.
Caregivers will also be asked to fill out a hospital created survey related to how satisfied they are with the care of the patient. It will be referred to as the Preoperative Hospital Satisfaction Survey (PHSS). This survey will be administered while the surgical procedure is in progress, when the caregivers are sitting in the waiting room. The survey is to be a reflection of how caregivers perceive preoperative separation care given to patients, so will not be influenced by surgical outcome.
Consent Legal guardians of patients are contacted over the phone by Patewood Outpatient Surgery Center registration per standard preoperative care procedure. Before concluding the normal preoperative interview, a script will be read that introduces the guardian to the study and its goals. The guardian will then be asked if they are interested in learning more about the study. Those who answer "no" will be removed from a list of potential participants. Those who answer "yes" or "maybe" will be given more information about study participation after arriving at the outpatient surgery center on the day of their scheduled appointment. A more thorough explanation of the study will be given and any questions answered. If a guardian is interested in participating, they will be provided a consent form to fill out.
Group assignment Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day.
Assessment and Survey Descriptions
Modified Yale Preoperative Scale (mYPAS)- Observational survey used to quickly score the anxiety level of children during preoperative holding and induction of anesthesia. It has frequent use and validation as an accurate tool for determining the anxiety level of pediatric surgical patients. Each section has 4 to 6 numbers listed, each corresponding with different patient description. For each section, the number by the most accurate patient description is circled. (Jenkins)(Kain)
State Trait Anxiety Inventory (STAI)- Self-taken survey for adults. Gives 2 different scores. One score is an indicator of susceptibility to stressful situations, the other score is the level of anxiety felt while taking the survey. It has frequent use and validation as a tool for determining anxiety levels of adults. (Spielberger)
Post Hospital Behavior Questionnaire (PHBQ)- Survey taken by primary caregiver of a patient after leaving the hospital. The survey is designed to identify maladaptive behaviors a patient has developed following a time at a hospital. Questions must be answered "much less than before", "less than before", "same as before", "more than before", or "much more than before". This survey is sensitive only to the change in frequency of behaviors, not their presence or absence. Therefore, undesirable behavior existing prior to a hospital stay should have no influence on the PHBQ score.
All surveys used in this study were truncated. Any modification was evaluated and approved by the staff psychologist (PhD.) familiar with using surveys to research anxiety and stress of patients and their families. Any questions that were included or excluded from the surveys was done so under expert direction.
Perioperative Holding After completing standard preoperative procedure, a nurse will complete a short observational survey (mYPAS [modified Yale Preoperative Scale] or mYPAS-SF) to score the patients current anxiety level. Just prior to separation from the caregiver, the patient will be given (or not given) a Video Game by the nurse. During separation, another mYPAS will be scored.
Operating Room Another mYPAS will be scored during the induction of anesthesia. If the patient has a video game, the patient is allowed to play as long as he/she wants. Often times, this is up until the procedure begins.
Caregivers During Procedure One or two primary caregivers will be asked to fill out a shortened STAI (State Trait Anxiety Inventory) and PHSS.
Follow-up Phone Calls The day following surgery, standard postoperative care procedure will be followed. This includes a phone call to the caregiver of a patient. Before concluding the phone call, the instructions at the top of the shortened PHBQ will be read to the caregivers participating in the survey. Then each question will be read and answered. One week and 2 weeks following surgery, the caregiver will be called and the shortened PHBQ will be administered.
Statistics The existence of correlations between maladaptive behavior, patient anxiety, caregiver susceptibility to anxiety, caregiver experience of anxiety, caregiver satisfaction, video game use, and any other collected data will be determined. All information from this study will be used to describe our cohort only. All data will be expressed in summary and is meant to contribute to the generalizable knowledge of the field.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day.
| Arm | Type | Receives |
|---|---|---|
| Game | Active comparator | Other: Hand-held video game devicePatients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day. |
| no game | Active comparator | Other: Hand-held video game devicePatients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- outpatient pediatric surgery patients between July 2016 and October 2016.
- Children, (ages 3-10 years) undergoing low-risk outpatient surgical procedures, including, but not limited to, tonsillectomies, adenoidectomies, etc., for which a masked induction was planned
- guardians of the children had to be present and consent.
Key exclusion criteria (5 listed)
- patients undergoing ear tube placement/removal (due to the short duration of the procedure)
- patients requiring premedication
- patients with physical or mental disabilities rendering it difficult to use the distraction device
- non-English speaking caregivers (due to the language barriers during the post-operative phone calls).
- patients without guardians providing consent
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 |
|---|---|---|
| Hand-held video game device | Other | Game, no game |
Primary outcome
Change in pediatric anxiety score
Time frame: at three timepoints in the peri-operative suite prior to induction for surgery
The modified Yale Preoperative Anxiety Scale16 (mYPAS): evaluated changes in pediatric anxiety with higher anxiety=higher score. mYPAS completed by nurses during initial preoperative evaluation, upon patient separation from parent and at mask induction. All three surveys were identical. A. Activity scored 1-4; B. Vocalizations scored 1-6; C. Emotional expressivity scored 1-4; D. State of apparent arousal scored 1-4
Change in parent anxiety score
Time frame: Immediately following separation from the child; change in anxiety from baseline
The Strait-Trait Anxiety Inventory (STAI)17 assessed self-reported parental anxiety (below). The STAI was completed by the parent immediately after separation in the waiting room. STAI consists of two parts: A= perceived anxiety during the child's perioperative period; B= the parent's general state of anxiety. Differences between these two metrics were used to indicate parental satisfaction with their experience. The A questions were evaluated with the following scale (1-4) utilizing the descriptors 'Not at all' 'Somewhat' 'Moderately So' 'Very Much So' in response to 7 statements. The B section regarding generalized anxiety was measured as follows (1-4) utilizing the descriptors 'Not at all' 'Somewhat' 'Moderately So' 'Very Much So' in response to 7 statements different from the A section. The final question is as follows (Y/N): 8. The experience of separation from my child for this procedure was better than expected. Y N
Overall Parental Satisfaction with the pre-operative process, particularly regarding parent/child separation
Time frame: Immediately following separation from the child
To evaluate overall satisfaction of parents with the pre-operative process specifically, a final question was added to the STAI which inquired if the parent/guardian thought that the experience of separation was better or worse than was expected. This question was scored independently.
Change in post-operative behavior as assessed by the parent
Time frame: 24-48 hours, 7 days and 14 days post procedure
The PHBQ queried change in perceived patient's behavior before and after the procedure with an inquiry regarding new-onset negative behaviors manifesting post-surgery. Three attempts were made to gather survey information for each time-point; if a parent could not be reached, data collection for that patient was truncated. Each of the three follow-up calls were completed utilizing the same protocol. The protocol consisted of 10 questions regarding the child's behavior with parent answers utilizing the following scale: much less less same more much more The final question was a rank from 1-10 with 10 being the worst (highest) score: 11. On a scale from 1 to 10, 1 being no pain and 10 being more pain, how would you rate your child's current pain level? 1 2 3 4 5 6 7 8 9 10
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 6 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-held video game device in people with Separation Anxiety and Anxiety, run by Prisma Health-Upstate.
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 3 inclusion and 5 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 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in pediatric anxiety score (time frame: at three timepoints in the peri-operative suite prior to induction for surgery). 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 6 Jul 2021.