Authors: Erin Brown (Child Health Research Centre, School of Medicine, The University of Queensland, Brisbane, Australia), Krittika Vongkiatkajorn (Department of Anaesthesia and Pain Medicine, Queensland Children's Hospital, Brisbane, Australia), Vanessa Rich (Department of Anaesthesia and Pain Medicine, Queensland Children's Hospital, Brisbane, Australia), Justin Kenardy (Child Health Research Centre, School of Medicine, The University of Queensland, Brisbane, Australia; School of Psychology, Jamieson Trauma Institute, Royal Brisbane and Women's Hospital, Queensland Health, The University of Queensland, Brisbane, Australia), Alexandra Donaldson (Department of Anaesthesia and Pain Medicine, Queensland Children's Hospital, Brisbane, Australia), Rebecca Paterson (Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Australia), Cameron Graydon (Department of Anaesthesia, Royal Children's Hospital, Melbourne, Australia), Paul Lee‐Archer (Child Health Research Centre, School of Medicine, The University of Queensland, Brisbane, Australia; Department of Anaesthesia and Pain Medicine, Queensland Children's Hospital, Brisbane, Australia)
Categories: Research Report, anesthetic induction, behavior, parent–child relationship, pediatric, perioperative anxiety, procedural anxiety, psychoeducation intervention, randomized controlled trial
Source: Paediatric Anaesthesia
Doi: 10.1111/pan.70006
The Effect of a Caregiver Preparation Video (Take5) on Child Anxiety During Anesthetic Induction: A Randomized Controlled Trial
Authors: Erin Brown, Krittika Vongkiatkajorn, Vanessa Rich, Justin Kenardy, Alexandra Donaldson, Rebecca Paterson, Cameron Graydon, Paul Lee‐Archer
Abstract
Background
A general anesthetic can be an anxiety‐provoking experience, and children who experience perioperative anxiety are more likely to have negative outcomes such as emergence delirium, increased analgesic requirements, and maladaptive behaviors. Parental presence at the induction of anesthesia can help reduce anxiety; however, only if the parent does not feel anxious themselves and can support their child in a positive way. The aim of this study was to test the efficacy of a short preparation video aimed at caregivers prior to the child's induction of anesthesia.
Methods
We conducted a randomized controlled trial of the Take5 video compared to standard care. The Take5 video was developed by pediatric anesthetists, child psychologists and a consumer panel of parents of children who had lived experience of surgery and anesthesia. The Take5 video is a 5‐min, animated video that prepares caregivers for what to expect during the anesthetic induction. It also provides the caregiver with suggested behaviors that will positively support the child during the induction and psychological coping strategies to manage personal distress. Participants were randomized to the standard preparation group or the intervention group, which consisted of standard preparation plus the caregiver being shown the Take5 video in the preoperative waiting area prior to accompanying their child to the operating room. The primary outcome was child anxiety at induction measured using the Modified Yale Preoperative Anxiety Scale—Short Form (mYPAS‐SF). Secondary outcomes were caregiver procedural behavior, child postoperative pain, emergence delirium, time to discharge, caregiver satisfaction and caregiver and child psychological wellbeing at 3 months.
Results
One‐hundred children and their caregivers were recruited to the trial. There was good to excellent inter‐rater reliability with all of the observer scales (intraclass correlation coefficient = 0.81 for the mYPAS‐SF). For the primary outcome of child anxiety at induction of anesthesia, there was good evidence for no difference between groups. For the secondary outcomes, the video intervention did not show any effect on parental behavior. There was a statistically significant difference in pain scores between groups, with children in the control group rated as having more pain on the Faces, Legs, Activity, Cry and Consolability (FLACC) scale (mean difference 0.6, 95% CI 0.04–1.16, p = 0.037). There was no difference shown in any of the other secondary outcomes including emergence delirium, time to discharge or caregiver satisfaction. There were also no differences in any of the 3‐month psychological wellbeing Child health‐related quality of life, child behavioral difficulties or parent depression and anxiety scores. Despite this, in semistructured interviews, caregivers reported the video to be acceptable and beneficial, but many would have preferred to see it in the days prior to their child's procedure.
Discussion
The Take5 video, shown to caregivers immediately prior to surgery, did not have any demonstrable effect on child anxiety at induction or on a range of postoperative outcomes; however, caregivers reported a perceived benefit to the child's induction experience. The results of this study did not show a measurable benefit of the Take5 video; however, this may be due to the timing of delivery. Providing this resource to families prior to coming into the hospital may be of benefit; however, further studies would be required to confirm this.
Trial Registration
This study was registered in https://www.anzctr.org.au/ (ACTRN12621001337864; October 5, 2021)
Background
Having a procedure under general anesthesia can be a distressing experience for children. Depending on their developmental level, they are particularly vulnerable to experiencing anxiety periprocedurally due to their varying cognitive abilities and ability to self‐regulate their emotions and behavior, and limited knowledge and experience of the healthcare environment. Young children, especially, rely on primary attachment figures for emotional regulation and behavioral cues.
Research reports that 65%–78% of children experience significant levels of perioperative anxiety [1, 2, 3]. For up to 70% of children undergoing elective surgery, induction of anesthesia can be an intensely distressing experience [4, 5]. Children who experience fear, anxiety, and distress in the preoperative phase are more likely to be less cooperative with induction of anesthesia and are at increased risk of postoperative emergence delirium and pain [5, 6, 7]. Over 50% of children can develop acute, negative behavioral outcomes following surgery under general anesthesia. Negative outcomes include separation anxiety, new fears, sleep disturbance, and aggression, with over 7% of children experiencing ongoing behavioral problems up to 12 months after discharge [8]. Having a child undergo a procedure can be a distressing experience for the attending family members; also, the symptoms of which can persist in the first month for up to 25% of parents and at least 6 months in 5% of parents [9]. Recent consumer‐driven research identifying priorities in pediatric perioperative medicine found that reducing fear and anxiety throughout the hospital experience, as well as improving communication with parents, was a high priority [10].
Currently, preoperative anxiety is managed through either pharmacological (sedative or anxiolytic medication) and/or nonpharmacological intervention. Pharmacological interventions can be associated with increased cost, hospital delays, slower discharge from hospital [11], and variable effect on emergence delirium and postoperative distress and behavioral changes [11, 12, 13]. Nonpharmacological interventions such as distraction and hypnotherapy have minimal side effects, but evidence for their efficacy remains variable [14].
It is common in many pediatric hospitals to allow parents to be present as their child is induced under anesthesia, recognizing that primary caregivers are the logical point of first contact, particularly for young children, to seek out support in uncertain situations such as anesthetic induction. However, the evidence for parental presence is mixed, as examined in the protocol for this study published by the authors [15], with one possible explanation being the impact of parental anxiety and the significant association between the parent's emotional regulation and that of their child's. Research which has found promising results from preoperative preparation targeting the parent [11, 16], involved resource‐intensive and time‐consuming processes that may not be feasible in all healthcare settings. Intervening in the acute phase of the child's treatment means that support and coaching must be delivered in a short and effective manner.
Prior to this study, members of the research team developed a short, animated video for caregivers of children having burn dressing changes. The video provided procedural preparation for caregivers, based on consumer feedback that this information was desirable and improved self‐efficacy [17]. behavioral coaching, based on positive behaviors identified from literature and previous research by the project team [18] and psychological self‐coaching strategies [19].
Unpublished findings for this video found parents demonstrated lower rates of anxiety, while children demonstrated significantly lower rates of anxiety and pain, postulated to be related to changes in parental behavior [20]. Additionally, parents and clinicians found the content and delivery of the video acceptable and had high intentions and confidence for using the behavioral strategies.
Based on this previous work, the authors tailored the “Take 5” video to the perioperative context, incorporating video modeling, coaching and education for the parents. This study, utilizing a mixed methods approach of a randomized control trial and qualitative analysis, aimed to evaluate the efficacy of the “Take 5” video in reducing anxiety and postoperative adverse outcomes.
Methods
Study Design
We conducted a single‐center, randomized controlled superiority trial to assess the efficacy of the Take5 video compared to standard care for the reduction of perioperative anxiety in children.
Participants
Children were eligible if they were between the ages of 3 and 10 inclusive and booked to have a day‐case procedure at the Queensland Children's Hospital. Children were excluded if they had a diagnosed developmental disorder, required emergency surgery, were under the care of the Department of Child Safety, if their parent had insufficient English language to understand the video, or if they were highly anxious requiring premedication.
Procedures
Eligible patients were provided with information about the study by a member of the research team and then written consent was obtained from parents and assent from children where possible. Participants were randomly allocated in a 1 ratio to the intervention or standard care group using sealed, opaque envelopes. All participants were observed by a member of the research team in the waiting room prior to induction using the Modified Yale Preoperative Anxiety Scale—Short Form (mYPAS‐SF), the Perioperative Adult‐Child Behavior Interaction Scale (PACBIS), during the anesthetic induction using mYPAS‐SF, PACBIS, and the Induction Compliance Checklist (ICC) and immediately after induction using the Cornell Assessment of Pediatric Delirium (CAP‐D) and the Face, Legs, Activity, Cry and Consolability Pain Scale (FLACC). Caregivers in both groups were asked to rate their levels of anxiety using VAS before and after the induction process. The induction was also videoed so a second blinded observer could rate the same measures at a later time point. For postsurgery follow‐up, parents were assessed after approximately 3 months via an online survey tool, using the Depression, Anxiety and Stress Scale (DASS‐21) and children using the Patient‐Reported Outcomes Measurement Information System (PROMIS) and Child Health Utility instrument (CHU9D). Further detail regarding the measures and timeline is available in the protocol [15].
Intervention
The intervention consisted of caregivers being shown the Take5 video while in the preoperative waiting area in addition to the usual preoperative preparation. The Take5 video contains psychological self‐coping strategies and procedural preparation. The standard care group was not shown the video and received usual preoperative preparation, which includes being assessed by preoperative nurses, anesthetists, and surgeons.
Take5 was designed to be implemented as a universal tool for all parents who attend their child's medical procedure, to increase parental psychological coping and associated behaviors, to target the child's procedural coping. Given the acute delivery design, Take5 was intentionally brief to be provided via a tablet in a clinical environment on the day of surgery prior to the procedure.
The Take5 video was developed using a consumer codesign model in conjunction with a panel of experts made up of pediatric anesthetists and child psychologists. The 5‐min animated video is designed to prepare caregivers for what to expect when accompanying their child for an anesthetic induction and to provide examples of positive behaviors they can use to support their child (Video S1). For a full description of the video development, refer to the published protocol [15].
Primary Outcome
The primary outcome of the study was the difference in child anxiety measured using the mYPAS‐SF [21].
Secondary Outcomes
Secondary outcomes Child and caregiver induction measured during induction using the PACBIS [22].Child induction measured during induction using the ICC [23].Child and parent postoperative Self‐rated by caregivers before and after induction and observed in children during recovery using the Visual Analog Anxiety Scale (VAS‐A) [24].Child emergence scored by a condition‐blinded recovery nurse as the child woke, using the CAP‐D [25].Child postoperative measured by a condition‐blinded recovery nurse as the child woke, via observation using the FLACC [26].Parent satisfaction with purpose‐built survey of feedback via numeric rating scale (1–10 of increasing satisfaction), patient experience survey.Parent and child 3‐month psychosocial measured using validated measures of adult psychological well‐being (DASS‐21) [27], child physical, mental, and social health (Patient‐PROMIS) [28] and health‐related quality of life (CHU9D) [29].Acceptability: a semistructured interview developed specifically for the Take5 video was used to assess acceptability of delivery and content of Take5.
Sample Size
Sample size was based on a similar preparation video used for caregivers of pediatric burns patients [20]. Assuming a clinical meaningful reduction in the mYPAS score of 15 with an estimated control group score of 55, then a sample of 50 participants per group was required to show this effect size with 90% power and an alpha error of 5%.
Statistical Analysis
Intention to treat analysis was used, normally distributed data was described using means and standard deviations, and non‐normally distributed data was described using medians and ranges or percentages as appropriate.
Primary and secondary outcomes measured before and at induction were analyzed using a mixed design ANOVA, or ANCOVA if control variables were required, to be able to also investigate the effect of time. Follow‐up variables with one timepoint were assessed using independent t‐tests.
Semistructured interviews were recorded using field notes and analyzed using qualitative content analysis [30]. The goal of this analysis was to describe the overarching themes raised throughout the interview, as well as individual experiences. Frequency of themes raised was also recorded. The analysis was conducted by a blinded author, and results were validated with the interviewer. Summaries were not returned or discussed with participants.
Results
We recruited 100 caregivers of children to the trial during the study period. Baseline demographics were similar between groups (see Table 1). Participants were randomized in a 1 ratio to the Take5 intervention arm and the standard care arm (see Consort diagram for full details). All children and caregivers completed the primary outcome measures; however, only 33 in each arm had data for the secondary outcome of emergence delirium, and only 16 and 19 in the intervention and standard care arms, respectively, completed the 3‐month follow‐up for psychosocial outcomes.
Measures
Technological difficulties occurred during two inductions, resulting in the video recordings failing to save. In these instances, the blinded rater could not score the behavioral measures, and the primary data collector's scores were imputed for analysis.
MYPAS
Interrater reliability was good (ICC = 0.81).
PACBIS
Interrater reliability was good for child distress (ICC = 0.78). Interrater drift was identified for the other behaviors. Child coping and caregiver distress‐promoting categories required 15 cases to be independently recoded to achieve good reliability (ICCs = 0.85, 0.83, respectively). Caregiver coping‐promoting required 30 cases to be independently recoded to achieve good reliability (ICC = 0.84).
ICC
Interrater reliability was excellent (ICC = 0.91; Figure 1).
Sample Characteristics
Sample characteristics by intervention condition are reported in Table 1.
Review of correlates identified child age as the only required control variable for behavioral variables. Table 2 reports the Pearson's r correlation values of age for behavioral variables, as well as means and standard deviations by intervention condition.
Primary Outcome: Child Perioperative Anxiety
It was hypothesized that children of caregivers in the Take5 intervention group would demonstrate less perioperative distress behaviors compared to children in the control group (H1). A mixed design ANCOVA was conducted to investigate the effect of intervention condition on mYPAS score over time (before, during induction), after controlling for child age. There was no main effect of intervention condition, and no interaction effect between time and intervention condition.
Secondary Outcomes
Child and Parent Induction Variables
Child induction behavior measures PACBIS‐SF and ICC, and parent‐reported child state anxiety using the VAS, a mixed design ANCOVA demonstrated no effect of intervention. Similarly for caregivers, mixed design ANCOVAs showed the intervention had no effect on caregiver self‐reported state anxiety using the VAS, or on caregiver positive and negative behavior as scored on the PACBIS.
Postoperative Pain, Emergence Delirium, Discharge Time
An independent t‐test was conducted, demonstrating nurses rated children in the control group as experiencing more pain (M = 0.76, SD = 1.93) than children in the intervention group (M = 0.16, SD = 0.55), mean difference = 0.6, 95% CI: 0.04–1.16, t
98 = 2.11, p = 0.037.
Emergence delirium was analyzed using 66 participants (nurses did not score 44 participants, distributed evenly across groups). Four children in the control group were scored with emergence delirium, compared to five children in the intervention group. An independent t‐test revealed no effect of intervention.
An independent t‐test was also conducted on time to discharge. No intervention effect was found.
3‐Months Postoperative Recovery
Independent t‐tests were conducted to compare the outcomes of child health‐related quality of life (CHU9D), child behavioral difficulties (PROMIS), and caregiver depression and anxiety scores (DASS‐21) at 3 months in intervention and control groups. No differences were found.
Cost‐Effectiveness
Cost‐effectiveness of the intervention, assessing direct and indirect healthcare costs to the healthcare system was planned. Without a significant result of the intervention, these analyses were not conducted.
Caregiver Satisfaction of Induction
Caregivers were asked to rate their satisfaction with the procedure. The majority of caregivers (85%) reported the top score of 100. An independent t‐test showed no differences between intervention and control groups.
Parent Acceptability of Intervention
A total of 13 interviews were conducted after induction for caregivers in the intervention group (initially 10 interviews, followed by three more interviews to confirm saturation). The interviews were semistructured, asking questions about the format, delivery, application, perceived outcome, and ongoing benefit of the intervention.
Format
All caregivers agreed the video format was preferable, and the language used was understandable. Most caregivers (85%) liked the design (attention‐grabbing, calming, creative), although one caregiver suggested more diverse representation, and another caregiver would have preferred photo images over drawings. One caregiver noted that the video is engaging for young children, but children should be given their own version, as one child (3 years old) became worried they would be separated from their caregiver after watching the video. Most caregivers (77%) reported they could follow the video structure, although two caregivers felt the video was too repetitive and long. One caregiver felt the video should have ended on the topic of distraction rather than psychoeducation. Some quotes from caregivers relating to the video “That's the only way to do it really,” “yes, it's a good medium,” “good, relatable, however not sure if it's diverse enough,” “video is great.”
Delivery
Half of the caregivers were satisfied with receiving the video on the day of the induction, and the other half would have preferred to receive it between 1 and 4 days before the surgery to prepare, practice role‐playing with the child, and limit anxious buildup. If provided on the day of induction, caregivers preferred it to be provided earlier while waiting, not immediately before induction. Most caregivers (77%) reported that the video did not interfere with the hospital visit. However, one caregiver reported that the video increased their anxiety about what might happen and whether they should be more worried. Some quotes relating to delivery of the “While waiting is ok but a day before so parents could prepare would be good. That way we can anticipate what to expect,” “as you wait is good, as it fills in the time,” “it helps us to be kept informed about the process,” “80% of it was good but 20% of it made me anxious.”
Application
All caregivers agreed that the information was applicable and sufficiently detailed to apply the strategies. All caregivers reported procedural preparation (what to expect) and parenting behaviors (distraction, focusing on the child's needs) were helpful information. Some caregivers then shared “what to expect” with their child. Some caregivers reported that psychoeducation (breathing, compassion exercise, and self‐care) was important; however, one caregiver commented that this element was not personally relevant.
Many caregivers (69%) reported using the strategies, whether before induction (preparing the child for what will happen), during induction (using distraction, breathing, and keeping calm), or after induction (self‐care while waiting for the child to go into recovery). Caregivers commonly spoke of working with the anesthetist to distract the child.
Most caregivers did not report barriers to using the strategies (62%), although interactions with anesthetists were commented on. Two caregivers reported they were not confident in the moment and relied on the anesthetist to lead the distraction; other caregivers with previous induction experiences reflected that every anesthetist approaches the induction differently and that they would prefer the anesthetist to communicate with the caregiver beforehand, so they could work together for consistent messaging to the child (be empowered). Some quotes relating to the application of the “It was helpful to talk him through what would be happening,” “the deep breathing was important for me,” “the doctors all have different techniques so we just need to play it by ear.”
Perceived Outcome
All caregivers felt the video made a difference to the procedure outcome, helping the procedure go faster because of less child anxiety. One caregiver said, “This time the induction process was much better as a result of experience and being prepared.”
Potential Future Benefits
All caregivers reported they will apply the strategies (breathing, distraction) to future medical procedures, such as visiting the dentist. “Yes, it made me think about what to say and do in the future,” “yes, all of them, breathing, distraction for both parties – parent and child.”
Discussion
This study tested the efficacy of the Take5 intervention on child and caregiver procedural and 3‐month outcomes. There was no effect of the intervention on perioperative anxiety measures for the child or caregiver. While postanesthetic variable pain was significantly reduced in the intervention group, the lack of effect on the child's perioperative anxiety as a potential modifier [1], suggests this finding was likely a Type 1 error, and in addition, the effect size was small. No effects were found for emergence delirium, time to discharge, 3‐month wellbeing outcomes, or caregiver satisfaction with the induction.
Caregiver acceptability interviews revealed possible explanations for no intervention effect. While caregivers accepted the video format, application, and reported perceive and potential future benefits, caregivers raised issues with the delivery timing. The study was designed to require low resource intensity in an elective surgery environment. The greatest challenges for recruiting to an RCT in this environment are emergent changes to the patient list, and the potential for the care team to give the child premedication for perceived anxiety (part of the exclusion criterion). This approach led to caregivers being recruited in the 10–20 min prior to the child's induction. Bailey et al. reported a similar nonsignificant result when providing a brief intervention immediately prior to induction [17]. In comparison, the ADVANCE study by Kain et al. successfully improved child perioperative outcomes through parental preparation but was much more resource intensive [11].
Further, the present study showed that caregiver behavior was not able to be adjusted immediately prior to the child's induction. This supports the findings by Bailey et al., and Kain et al., that more time is required for parents to consolidate the information and prepare (themselves and the child) for a nondistressing induction [11, 17]. There is potential for the Take5 video to be valuable resource in the days leading up to a child's anesthetic induction if operational procedures can be adjusted, such as if elective surgery coordinators can provide a link to the video as part of booking confirmation procedures.
Another finding from the interviews was the caregiver's dynamic with the anesthetist. The Take5 video was designed to empower caregivers to use these techniques with the child, but caregivers reported that the anesthetist did not always facilitate empowering the caregiver. Although parents may know their children best, they may not be equipped to respond to specific events (i.e., anesthetic induction) while also experiencing elevated levels of anxiety themselves. In contrast, pediatric anesthetists are often well trained in controlling the induction experience with distraction and guided imagery techniques. Therefore, while parents prefer to be present for their child's medical procedures [31], they can have both a positive and negative influence on their child's procedural anxiety [19], and further consideration about preparation for the parent's role and their ability to cocreate a conducive environment alongside trained clinicians during induction, remains necessary and an important area of research for patient centered care.
Improving the parent's skills in supporting their child and managing their own emotions during a child's anesthetic induction is an important factor to a successful (nondistressing) induction. Caregivers reported the Take5 video was acceptable and beneficial to the induction experience, showing a bias toward believing the video had been helpful.
Strengths and Limitations
The strength of this study is that it was a randomized, controlled trial and it tested an intervention that was developed using an evidence‐based approach with input from pediatric anesthetists, psychologists, and consumers. Additionally, the direct assessment of the intervention on parental behavior allowed testing of whether the intervention had the desired effect. This inclusion builds on the study design by Bailey et al. [17], and led to further consideration of whether the video did not act as intended due to timing and/or practice requirements.
The limitation of the study was it was a single‐center study, which may limit the generalisability of the results. For example, access to and skill training of pediatric anesthetists varies across hospitals. While the skillset of the pediatric anesthetists in this study to use distraction and guided imagery is of clear benefit, it also limited the need for the parent to provide similar support to their child. Evaluation of the utility of this resource in centers without dedicated pediatric anesthetic services may be beneficial. Furthermore, the timing of the intervention may not have been optimal, with many caregivers expressing that they would have liked more time to prepare after watching the video. There may also be a benefit for tailored preparation material for specific patient groups. For example, in this trial 12% of the control group and 6% of the intervention group identified as Indigenous. Culturally appropriate messaging codesigned with First Nations people may be more effective than the generic version used in this study. Finally, the response rate at the 3‐month timepoint was low, despite participants receiving two reminders to complete the survey. A previous study [32] has reported a similar rate of response in parents of young children after a child's medical event. It is possible that the parents were either too busy with general life events to complete the survey, and/or did not perceive benefit of engagement because their child was not displaying any psychological distress symptoms.
Future research should be designed to ensure there is sufficient time for knowledge acquisition and application of the intervention. Overall, the challenge to successfully modify parental behavior to improve child induction experience and recovery remains.