Preoperative, AnxietyChildLifeNCT02395094
Study to Examine the Effects of Child Life Interventions on Children's Anxiety Levels at Induction of Anesthesia
A study testing Child Life in people with Preoperative, Anxiety, run by University of British Columbia at 1 site in Canada.
Trial summary
Children can experience high levels of anxiety immediately prior to surgery. In fact, this can be the most stressful part of the whole surgical experience for children. Anxiety before surgery is associated with problems after surgery; such as short-term increased need for pain medication and long-term sleep… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Preoperative, Anxiety
- What is being tested?
- Child Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Undergoing elective day surgery under general anesthesia, expected to last ≤ 2 hours
- ASA I to III
- Ages 3 - 10y
- Written parental/guardian informed consent and subject informed assent when required (subject age ≥ 7 years)
Who cannot join
- Previous surgery
- Severe anxiety (according to the staff anesthesiologist) in the preoperative period, requiring sedative pre-medication
- Severe anxiety in the preoperative period, deemed to require intervention by Child Life
- Anticipated mask induction of anesthesia
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital Department of Anesthesia
Vancouver, British Columbia, V6H 3V4
About this study
Children can experience high levels of anxiety immediately prior to surgery. In fact, this can be the most stressful part of the whole surgical experience for children. Anxiety before surgery is associated with problems after surgery; such as short-term increased need for pain medication and long-term sleep disturbances or behaviour change. Child Life, a program run in some North American children's hospitals has developed ways to reduce children's anxiety prior to surgery. These techniques can include role-play or story books amongst others.
In this study, the investigators aim to look at the benefits of the Child Life techniques on anxiety levels of children and their caregivers just prior to receiving anesthesia in the operating room. The study will include children between the ages of 3 and 10 years old, needing day case surgery lasting less than 2 hours, and having never had surgery before. They will be randomly allocated to either not receive any intervention by Child Life or to receive Child Life intervention in the period prior to their surgery, when they are waiting in the Surgical Day Care Unit. Anxiety levels of the children and their caregivers will be measured as they arrive in the hospital and immediately prior to anesthesia, to see if there is a lower level of anxiety in the group receiving the Child Life intervention.
Read the detailed description
RESEARCH DESIGN:
This is a prospective, randomized controlled clinical trial that will assess the effectiveness of immediate preoperative Child Life intervention in reducing preoperative anxiety prior to induction of anesthesia.
This prospective, randomized controlled clinical trial will compare two groups of children undergoing induction of anesthesia.
- Group 1 (Standard Procedure) will receive BCCH standard care, which consists of topical anesthetic cream, waiting with parents in the playroom in the surgical daycare unit preoperatively, parental presence in the operating room (OR), the BC Children's Hospital (BCCH) 'parent hug' and standard distraction techniques
- Group 2 (Child Life) will receive Child Life intervention applicable to the individual patient, on the day of surgery in addition to standard practice techniques
The primary outcome measures will be the scores from validated observer ratings of anxiety at induction of anesthesia. A trained research assistant (RA) will observe and score the child's anxiety using the following validated tools:
- The modified Yale Preoperative Anxiety Scale - short form (m-YPAS-SF), designed specifically to assess the preoperative anxiety in children aged 3 to 12 years, using real-time observational assessment of the child's anxiety-indicating behaviours (activity, vocalizations, emotional expressivity and state of arousal).
- The Perioperative Adult Child Behavioral Interaction Scale (PACBIS), designed for real-time evaluation of perioperative anxiety behaviours of children and parents, which include child coping behaviours and parent-positive/negative behaviours.
STUDY PROCEDURES
Baseline anxiety score and randomization:
On the child's arrival in the Surgical Day Care Unit (SDCU), a baseline observational anxiety score will be taken by the RA (at t0), using the m-YPAS-SF.
The RA will then leave SDCU prior to randomization, which will be carried out by the Child Life specialist. Consented subjects will be randomly assigned into one of two groups to receive either Standard Procedure (n = 30) or Child Life (n = 30). Groups will be randomized using computer generated random numbers.
In the SDCU:
Following the baseline anxiety scores and randomization, the child will then follow as per SDCU policy. If the child has been randomized to receive Child Life intervention (Group 2), then the Child Life specialist will carry out the interventions, prior to the child coming to the OR. All other processes will be as standard: the anesthesiologist and dentist making their preoperative visit, analgesic premedication being given, etc.
Child Life specialists work around other clinical activities. In some cases, there may not be enough time to provide sufficient Child Life guidance; for example, some patients are 'fast tracked' if the OR is running ahead of schedule or if the family arrives late. If the participant is in group 2, we will require that the Child Life specialist be able to spend a minimum of 15 minutes with the child and family. If that is not possible, the family will be excluded from further participation in the study and from any data analysis.
Similarly, if the case is delayed by > 1 hour or is postponed to another day, the family will be excluded from further participation in the study and from any data analysis.
In the OR:
All subjects will enter into the OR with one caregiver, according to BCCH standard policy. Distraction will consist of the usual techniques employed by the attending anesthesiologist and OR staff. These techniques will not be standardized or altered for the purpose of the study and may include such measures as bubbles, storytelling, video, or music.
The RA will be present in the OR and score the subject's state anxiety (m-YPAS-SF) and the anxiety behaviours of the subject/parent (PACBIS) at the time (t1) of IV insertion or attempt at IV insertion. Planned mask inductions of anesthesia will be excluded, but in some cases, the anesthesiologist may elect to proceed with a mask induction after attempting an IV insertion. The m-YPAS-SF and PACBIS scoring will still be possible during the initial attempt at IV insertion.
- Conditions
- Preoperative, Anxiety
- Being tested
- Child Life
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child LifeBehavioural
Child Life preparation in surgical daycare can include:
- role-play using dolls and medical equipment (either toy doctor kits or true medical materials)
- the use of books/storyboards that show pictures of operating room and daycare routines
- teaching \& rehearsing coping and relaxation skills such as deep breathing and guided imagery
- age-appropriate explanation of what to expect throughout the day in SDCU
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Standard Procedure) | No intervention | Group 1 (Standard Procedure) will receive BCCH standard care, which consists of topical anesthetic cream, waiting with parents in the playroom in the surgical daycare unit preoperatively, parental presence in the OR, the BCCH 'parent hug' and standard distraction techniques |
| Group 2 (Child Life) | Experimental | Group 2 (Child Life) will receive Child Life intervention applicable to the individual patient, on the day of surgery in addition to standard practices Receives: Behavioral: Child Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety using m-YPAS-SF scoring tool
Observational ratings of preoperative anxiety using m-YPAS-SFscoring tool
Measured: 1 hour
Secondary outcomes (1)
Preoperative anxiety using PACBIS scoring tool
Observational rating of preoperative anxiety using PACBIS scoring tool
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative, AnxietyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoe Brown, University of British Columbia
- Investigators
- Zoe Brown, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395094
- Sponsor's protocol ID
- H15-00342
- Acronym
- ChildLife
- Status last verified
- Oct 2017
- First submitted
- 16 Mar 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Examine the Effects of Child Life Interventions on Children's Anxiety Levels at Induction of Anesthesia
- ClinicalTrials.gov ID
- NCT02395094
- Acronym / sponsor ID
- ChildLife / H15-00342
- Conditions
- Preoperative, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Mar 2015 (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.
Children can experience high levels of anxiety immediately prior to surgery. In fact, this can be the most stressful part of the whole surgical experience for children. Anxiety before surgery is associated with problems after surgery; such as short-term increased need for pain medication and long-term sleep disturbances or behaviour change. Child Life, a program run in some North American children's hospitals has developed ways to reduce children's anxiety prior to surgery. These techniques can include role-play or story books amongst others.
In this study, the investigators aim to look at the benefits of the Child Life techniques on anxiety levels of children and their caregivers just prior to receiving anesthesia in the operating room. The study will include children between the ages of 3 and 10 years old, needing day case surgery lasting less than 2 hours, and having never had surgery before. They will be randomly allocated to either not receive any intervention by Child Life or to receive Child Life intervention in the period prior to their surgery, when they are waiting in the Surgical Day Care Unit. Anxiety levels of the children and their caregivers will be measured as they arrive in the hospital and immediately prior to anesthesia, to see if there is a lower level of anxiety in the group receiving the Child Life intervention.
Detailed description
RESEARCH DESIGN:
This is a prospective, randomized controlled clinical trial that will assess the effectiveness of immediate preoperative Child Life intervention in reducing preoperative anxiety prior to induction of anesthesia.
This prospective, randomized controlled clinical trial will compare two groups of children undergoing induction of anesthesia.
- Group 1 (Standard Procedure) will receive BCCH standard care, which consists of topical anesthetic cream, waiting with parents in the playroom in the surgical daycare unit preoperatively, parental presence in the operating room (OR), the BC Children's Hospital (BCCH) 'parent hug' and standard distraction techniques
- Group 2 (Child Life) will receive Child Life intervention applicable to the individual patient, on the day of surgery in addition to standard practice techniques
The primary outcome measures will be the scores from validated observer ratings of anxiety at induction of anesthesia. A trained research assistant (RA) will observe and score the child's anxiety using the following validated tools:
- The modified Yale Preoperative Anxiety Scale - short form (m-YPAS-SF), designed specifically to assess the preoperative anxiety in children aged 3 to 12 years, using real-time observational assessment of the child's anxiety-indicating behaviours (activity, vocalizations, emotional expressivity and state of arousal).
- The Perioperative Adult Child Behavioral Interaction Scale (PACBIS), designed for real-time evaluation of perioperative anxiety behaviours of children and parents, which include child coping behaviours and parent-positive/negative behaviours.
STUDY PROCEDURES
Baseline anxiety score and randomization:
On the child's arrival in the Surgical Day Care Unit (SDCU), a baseline observational anxiety score will be taken by the RA (at t0), using the m-YPAS-SF.
The RA will then leave SDCU prior to randomization, which will be carried out by the Child Life specialist. Consented subjects will be randomly assigned into one of two groups to receive either Standard Procedure (n = 30) or Child Life (n = 30). Groups will be randomized using computer generated random numbers.
In the SDCU:
Following the baseline anxiety scores and randomization, the child will then follow as per SDCU policy. If the child has been randomized to receive Child Life intervention (Group 2), then the Child Life specialist will carry out the interventions, prior to the child coming to the OR. All other processes will be as standard: the anesthesiologist and dentist making their preoperative visit, analgesic premedication being given, etc.
Child Life specialists work around other clinical activities. In some cases, there may not be enough time to provide sufficient Child Life guidance; for example, some patients are 'fast tracked' if the OR is running ahead of schedule or if the family arrives late. If the participant is in group 2, we will require that the Child Life specialist be able to spend a minimum of 15 minutes with the child and family. If that is not possible, the family will be excluded from further participation in the study and from any data analysis.
Similarly, if the case is delayed by > 1 hour or is postponed to another day, the family will be excluded from further participation in the study and from any data analysis.
In the OR:
All subjects will enter into the OR with one caregiver, according to BCCH standard policy. Distraction will consist of the usual techniques employed by the attending anesthesiologist and OR staff. These techniques will not be standardized or altered for the purpose of the study and may include such measures as bubbles, storytelling, video, or music.
The RA will be present in the OR and score the subject's state anxiety (m-YPAS-SF) and the anxiety behaviours of the subject/parent (PACBIS) at the time (t1) of IV insertion or attempt at IV insertion. Planned mask inductions of anesthesia will be excluded, but in some cases, the anesthesiologist may elect to proceed with a mask induction after attempting an IV insertion. The m-YPAS-SF and PACBIS scoring will still be possible during the initial attempt at IV insertion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Standard Procedure) | No intervention | –Group 1 (Standard Procedure) will receive BCCH standard care, which consists of topical anesthetic cream, waiting with parents in the playroom in the surgical daycare unit preoperatively, parental presence in the OR, the BCCH 'parent hug' and standard distraction techniques |
| Group 2 (Child Life) | Experimental | Behavioral: Child LifeGroup 2 (Child Life) will receive Child Life intervention applicable to the individual patient, on the day of surgery in addition to standard practices |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Undergoing elective day surgery under general anesthesia, expected to last ≤ 2 hours
- ASA I to III
- Ages 3 - 10y
- Written parental/guardian informed consent and subject informed assent when required (subject age ≥ 7 years)
Key exclusion criteria (4 listed)
- Previous surgery
- Severe anxiety (according to the staff anesthesiologist) in the preoperative period, requiring sedative pre-medication
- Severe anxiety in the preoperative period, deemed to require intervention by Child Life
- Anticipated mask induction of anesthesia
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 |
|---|---|---|
| Child LifeChild Life preparation in surgical daycare can include: * role-play using dolls and medical equipment (either toy doctor kits or true medical materials) * the use of books/storyboards that show pictures of operating room and daycare routines * teaching \& rehearsing coping and relaxation skills such as deep breathing and guided imagery * age-appropriate explanation of what to expect throughout the day in SDCU | Behavioural | Group 2 (Child Life) |
Primary outcome
Preoperative anxiety using m-YPAS-SF scoring tool
Time frame: 1 hour
Observational ratings of preoperative anxiety using m-YPAS-SFscoring tool
1 secondary outcome
Preoperative anxiety using PACBIS scoring tool
Time frame: 10 min
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 27 Oct 2017.
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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.
Zoe Brown principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child Life in people with Preoperative, Anxiety, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 4 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 27 Oct 2017. 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 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?
Preoperative anxiety using m-YPAS-SF scoring tool (time frame: 1 hour). 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 27 Oct 2017.