The Caregiver Burden of Helmet Therapy following Endoscopic Strip Craniectomy: A Phenomenological Qualitative Study

Abstract

Introduction

This cohort study aimed to elucidate the caregiver burden of helmet therapy (HT), following endoscopic strip craniectomy (ESC) to treat craniosynostosis, in an effort to inform clinicians and future caregivers navigating this therapeutic option.

Methods

Fourteen caregivers of children with positional plagiocephaly (6) and craniosynostosis treated by ESC (8) undergoing HT at a single center were recruited via convenience sampling. Using a phenomenological qualitative approach, semi-structured interviews were conducted to understand the experience of HT for caregivers. Data collection and analysis were iterative and conducted until thematic saturation was reached.

Results

Emerging themes revealed five domains of caregiver burden: emotional, cognitive, physical, psychosocial, and financial. No caregiver felt the therapy was too burdensome to complete. Caregivers of both groups also expressed positive aspects of HT related to support from the team, the noninvasive nature of treatment, and the outcomes of therapy. Furthermore, caregivers report overall satisfaction with the process, stating willingness to repeat the treatment with subsequent children if required.

Conclusion

HT is associated with five major domains of caregiver burden; however, none of the caregivers regret choosing this treatment option, nor was the burden high enough to encourage treatment cessation. This study will inform future prospective analyses that will quantify real-time caregiver burden throughout HT.

Introduction

Despite its frequent use for the treatment of positional plagiocephaly [1–4] and postoperative management following endoscopic strip craniectomy (ESC) [5–9], cranial remodeling orthosis or helmet therapy (HT) is often criticized for its burden of care on caregivers [10–13]. Critics of HT report that the longitudinal need for constant helmet wear creates undue harm for the child and caregivers, on account of multiple trips to the hospital and associated time off work [13], presumed inconvenience of helmet wear, and financial burdens [10, 11]. To close the gap between what is known and what is presumed, more research is needed to understand the caregivers’ experience with HT following ESC. This information may allow for more accurate preoperative counseling and informed consent when presenting surgical options to caregivers of children with craniosynostosis.

Caregiver burden describes the physical, psychological, social, and financial stressors that can be experienced by caregivers of a chronically ill or impaired patient [14]. In pediatric populations, caregivers are essential to treatment support and adherence [15]. Therein, understanding caregiver burden is pertinent to improving overall care and treatment success rates [16–18]. HT’s success in treatment of craniosynostosis following ESC is reliant on consistent helmet application and caregiver compliance, which may be negatively affected by undue caregiver burden. With an accurate understanding of the burden of care associated with HT, healthcare providers can educate future caregivers about the potential burdens to prepare them for the treatment course and encourage adherence, thereby improving results. They may also counsel caregivers regarding other treatment options if, together, they determine that the caregiver burden associated with HT might create undue stress for the caregiver.

The caregiver burden for HT in children with plagiocephaly has been deemed significant by previous studies [10, 11, 19, 20]. It is projected to include the negative sequelae of financial burden [10, 11, 19–21], healthcare system inundation [20], quality of life reduction [11, 20], and stigma [20]. One might presume that the same burdens would be experienced by caregivers of children receiving HT following ESC; however, when caregivers choose to pursue ESC and HT, they are avoiding a more invasive surgical option such as open cranial vault remodeling. The relief associated with avoiding a more invasive surgery may influence the caregivers’ perceptions of burden of care. As such, we sought to interview caregivers of both children with plagiocephaly and craniosynostosis to generate a rich understanding of the caregivers’ experience with HT, focusing primarily on the burden of care. Through this study, we aimed to generate practical information that may be useful for caregivers and providers navigating treatment options in the management of both positional plagiocephaly and craniosynostosis.

Methods

Study Design

We employed a descriptive, phenomenological, qualitative approach to generate an understanding of the experience of caregivers of children undergoing HT for plagiocephaly and craniosynostosis following ESC. A phenomenological approach is best used to address the topic of caregiver burden as the approach allows for capturing the essence of experiences associated with various phenomena [22, 23]. Participants were recruited via convenience sampling by a researcher independent to the care team. Inclusion criteria were English-speaking caregivers of children up to 2 years of age who were currently undergoing or had recently completed HT within the last 2 months in the treatment of plagiocephaly or following ESC. Caregivers of patients with a diagnosis of torticollis or syndromic craniosynostosis were excluded from the study as they may also be managing simultaneous burdens of care that might confound the data.

Ethical Considerations and Consent

Ethics approval was received from the Hospital for Sick Children’s (SickKids) Research Ethics Board (REB). The hospital’s electronic medical records system – Epic – was utilized to pre-screen for eligible patients in the craniofacial and orthotics clinic. Caregivers of eligible patients were informed, in the clinic, of the study purpose, procedures, responsibilities, risks, benefits, and the choice to withdraw; those who agreed to participate provided written consent and scheduled an interview that would follow a prior scheduled orthotics clinic visit. No financial compensation was provided for participants in this study.

Data Collection and Analysis

The demographics questionnaire was completed using Research Electronic Data Capture (REDCap Software, version 6.0, Nashville, TN, USA). Semi-structured interviews were conducted by a researcher independent to the care team to create a neutral environment in which participants could describe their experiences. The interviews were conducted one-on-one using the communication software Microsoft Teams (MS Teams). The MS Teams transcription tool was used to transcribe the interview audio recordings, and video cameras were turned off to promote comfort. Interviews were conducted from June 2022 to October 2022. The interviews were 20 to 30 min long and consisted of open-ended questions to cover topics on quality of life, finances, and stress associated with HT. The list of semi-structured interview questions and probes can be found as the attached online supplementary material (for all online suppl. material, see https://doi.org/10.1159/000539299). Participants were also given the opportunity to volunteer any further details of their experiences that they had not been asked about. All interviews were reviewed by a research staff member to ensure transcript accuracy.

Recruitment, data collection, and data analysis were iterative; conducted until thematic saturation was reached. The researchers engaged in member-checking by performing follow-up interviews with the participants to clarify responses and ensure a clear understanding of the participants’ experiences. The interview transcripts were analyzed using line-by-line coding on NVivo 12 software (version 12.7.0) by two researchers independent to the care team (T.E. and A.H.), thereby practising reflexivity and minimizing influence on the participants. Emerging themes were elicited by comparing of coding books until consensus was achieved. Peer debriefing was also employed, and the study team had periodic meetings to discuss all aspects of the study including the qualitative interviewing procedures, data collection, data quality, saturation, and thematic analysis, to ensure that there was consensus at every stage.

Results

A total of fourteen caregivers of children with positional plagiocephaly (6) and craniosynostosis following ESC (8) completed both the demographics questionnaires and interviews. Data analysis reached thematic saturation after fourteen interviews, and recruitment was stopped thereafter.

The median age of the caregiver participants was 37 years. The median age of the children was 10.5 months. Caregiver demographics are listed in Table 1.

Table 1.

Participant demographics

Characteristics	n (%)	Median
Caregiver	14 (100)
Age of the caregiver, years		37
Gender
Female	12 (86)
Relationship to the child
Mother	12 (86)
Father	2 (14)
Marital status
Married	13 (93)
Single	1 (7)
Number of caregivers at home
Two parents	11 (79)
More than two parents	3 (21)
Maternity leave
Yes	7 (50)
Education, n (%)
High school	1 (7)
College/university	8 (57)
Graduate degree	5 (36)
Income, CAD
25,000–39,000	2 (14)
40,000–59,000	1 (7)
60,000–99,000	1 (7)
100,000–249,000	8 (57)
>250,000	1 (7)
Prefer not to answer	1 (7)
Employment status
Full time in the office	6 (43)
Full-time work from home	1 (7)
Other	5 (36)
Maternity leave	4 (80)
Self-employed	1 (20)
Effects of COVID-19 on employment
Unemployed	2 (14)
Reduced hours	3 (21)
Full-time work from home	3 (21)
Hybrid work	1 (7)
Essential worker	5 (36)
Insurance coverage
Yes	11 (79)
No	3 (21)
Child	14 (100)
Age, months		10.5
Gender
Male	10 (71)
Diagnosis
Craniosynostosis	8 (57)
Positional plagiocephaly	6 (43)

Domains of Caregiver Burden

Thematic analysis revealed five domains of burden of care for caregivers of children undergoing HT for plagiocephaly and following ESC, which include emotional, cognitive, physical, psychosocial, and financial. These themes were experienced equally by both plagiocephaly and craniosynostosis caregiver groups, and analysis revealed no differences between the groups. The distribution of the five domains and their expanded themes, as well as direct caregiver quotes, is presented in Table 2. “Pc” represents participants in the craniosynostosis group, while “Pp” represents participants in the plagiocephaly group.

Table 2.

Domains of caregiver burden: expended themes

Domain (% of burden)	Theme/code	Quotes
Emotional (11.88%)	Bonding limitations	“There’s a lot going on when you just give birth and[are] recovering,[like] anxiety and depression; and then you have to watch for this – the baby’s head and everything.” (Pp8)
	New experience/adjustment period	“You can’t see what’s going on because the helmets on, so it was a lot of[wondering] what is going on under there – is it working?[But] the visits when they scanned[the head] really helped because I could really see the difference with the information that they gave me.” (Pp10)
	Anxious about results
	Frustrated with helmet fit
Cognitive (15.84%)	Scheduling conflicts	“We’re down there every 2 weeks[and] I have multiple children – it’s hard to find childcare.” (Pc5)
	Navigating care with their other children	“At first, we were really worried and scared as to how he would adjust to[helmeting], being that he was only 3 months old, and we had no previous experience with helmet therapies.” (Pc14)
	Balancing motherhood	“[At visits] they take the helmet away and go adjust it and bring it back. So, it was constantly[like] she would settle and then[it will] be fidgeted with again…it was kind of hard.” (Pc3)
	Child’s comfort and experience
	Child’s head shape
	Helmeting outcomes
Physical (50.5%)	Cleaning and daily tasks	“[Helmeting] added maybe 30 to 40 minutes to the regular routine with the baby. But later on, probably even less[time as it became] part of the procedure for bedtime. So, while the baby is in[the] bath or just before that, the helmets is being cleaned.” (Pc4)
	Time added to the regular routine	“It[depends] on the appointment,[but] when she got a new helmet it was probably about a good 3 hours. I think our shortest one was an hour and a half, and that was just a readjustment.” (Pc3)
	Temperature regulation
	Minor adverse events	“It’s a 2-ish hour drive down and then the COVID screening always takes a minute. Depending on the day, I’ve been down there for 4 hours.” (Pc5)
	Time commitment
	COVID-19 pandemic effects
Psychosocial (10.89%)	Attention in public	“Only one of us was allowed in the hospital for probably half of his helmet journey just because of the COVID regulations so that meant one of us waiting in the car and there was nowhere to go to the bathroom; and it was winter for half of it, so that was brutal… and the emotional side of things – where only one of us was allowed to go in[for the appointment] was really difficult.” (Pc13)
	Decrease in social activities	“I think the hardest part is that we live at the cottage right next to the lake, and I wasn’t able to have the summer that I was planning with[the infant] to go swimming every day because of the 23 hours with the helmet on. So, I think that was the most frustrating part.” (Pp10)
	COVID-19 pandemic effects
	Others’ perceptions
Financial (10.89%)	Indirect costs (only; no direct costs)	“We needed to rent a car for[the appointment] day, and[we] count that[as] one of those days we[couldn’t] be at work; so[those are] additional[costs]…” (Pc4)
		“[The hospital] offers the USCAD 10 a day parking pass for families. So yeah, I went through a couple USCAD 100 of them just with the visits and everything.[Also] with helmet therapy we bought a special shampoo for him just because we wanted to make sure that[we were] conscious of his skin so that nothing would irritate it. We were lucky that Vaseline was a simple fix for him[for red spots] so that was something[additional].” (Pc14)

Pc, participants from the craniosynostosis following ESC group; Pp, participants from the plagiocephaly group.

Emotional

A variety of stressors contributed to the emotional burden of care, including anxiety related to a myriad of unknowns and new adjustment periods. Caregivers also described anxiety related to general unfamiliarity with HT and uncertainty regarding ultimate treatment results. One caregiver described bonding limitations related to HT stating that, “The biggest transition for me was not being able to nuzzle his head [often]… so it’s kind of taken that bonding piece away” (Pc5). Other elements of this domain are highlighted in Table 2.

Cognitive

The cognitive burden of care was expressed with respect to navigating schedules and scheduling conflicts, mental preoccupation about the child’s tolerance of the procedure, helmeting outcomes, and navigating care with their other children. As one caregiver with multiple children explained, “it is a little bit challenging to take off the helmet, put everyone in the car, get all the car seats buckled up, and then bring the helmet; and then when we get there, [get] everyone out of the car [and putting] the helmet back on. It’s just a lot” (Pc5). However, caregivers report that these concerns were assuaged as the treatment progressed and they developed better management techniques and routines (Table 2).

Physical

This was the most prominent domain, expressed by over half of the caregivers in this study. It encompasses a wide range of burdens that are a result of the effects of physical changes to the patient, as well as strain on daily functioning and routines – with additional time commitment experienced by the caregivers. Some of these include cleaning and wear time; temperature regulation with increased sweating and helmet odor; minor adverse events like rashes, eczema, pressure spots, skin tears, and infections. For one caregiver, “it was winter but [the infant] was hot, he broke out in a heat rash over his entire body, and he was wearing almost next to no clothes, and it was January [but] the helmet made him so hot; and then through the summer [it] was really challenging too because he was so hot” (Pc13). The caregivers who noted pressure spots, skin tears, and infections reported that even though these were all minor – resolving with Vaseline, polysporin ointment, and helmet adjustments – they were particularly burdensome to witness and manage in infants and young children. There were also reports of increased time commitment as evidenced by long commute times, as well as appointment frequency and length, which was exacerbated by extra screenings due to the COVID-19 pandemic.

Psychosocial

The psychosocial aspects of caregiver burden were related to attracting attention in public and helmet aesthetics. One caregiver reported: “Whenever I am just holding him and walking people [stare] at him, [while] some ask me – What’s going on with his head? What happened with him?” (Pc1); while another caregiver lamented: “I was very scared to take him out in public because I didn’t want people to look at him differently or think of me as a bad mom because I know there’s a stigma around helmet babies having flatheads because their parents just leave them [laying down] all the time… and I didn’t want [to] have to deal with any negative comments, so we didn’t go anywhere – [this] was a challenge I’ve had to work through” (Pc5). Nevertheless, some caregivers would have preferred more questions asked than assumptions made. As one caregiver noted: “I wish people asked questions [as] that would have been better”. One woman said, “I didn’t realize being in the stroller was a full contact sport,” which really bugs me because, again, just ask” (Pc2). Furthermore, another aspect of the psychosocial domain of caregiver burden involved the decrease in social events like community water and swim activities, which was exacerbated by the COVID-19 pandemic, ultimately leading to feelings of isolation as outlined in Table 2.

Financial

The financial aspects of caregiver burden were largely due to indirect costs. Even though HT is not covered by the Ontario Health Insurance Program (OHIP), it is covered by some extended health benefits programs purchased by the individual or employer. In cases of craniosynostosis where the caregiver did not have extended health benefits or their benefits did not cover the cost of the helmet, helmet costs were covered by the Hospital for Sick Children (SickKids). This was not available for families of children with plagiocephaly; however, most participants in this study (78%) reported having health insurance policies that fully reimbursed the costs of HT. Caregivers relayed initial financial concerns related to the direct cost of HT, but this was alleviated when they found out they had financial coverage either through private insurance or the Hospital for Sick Children (SickKids). One caregiver stated: “at first it was a little daunting, but then we found out about the program that orthotics has [where] my husband’s private insurance covered 80% and then SickKids [Craniofacial Program] reimbursed us the additional 20%. So, we haven’t had to pay for anything… except gas and parking” (Pc5). Many others shared their sentiment as none of the caregivers in this study were directly responsible for the full cost of the helmet and HT. Nevertheless, the indirect costs of care – parking, gas, time off work, babysitting, and cleaning products – formed the basis of the financial domain of caregiver burden in this study (Table 2). As one caregiver remarked, “there’s the added cost of all our travel time, gas, parking…plus my husband and I, because we’re so far away, we’d have to take an entire day off of work, so missed days of work [were] a huge cost, especially when we were going down every week or two” (Pc13).

Additional Themes

Although the semi-structured interviews were designed to investigate the burden of care associated with HT, all caregivers also wanted to discuss the positive experiences of HT in addition to providing advice to other caregivers embarking in this therapeutic option. This highlights the multifaceted experience of HT for caregivers.

Some caregivers outlined reasons to pursue HT over other treatment options based on overall satisfaction with results. One caregiver remarked: “I just thought it was really great. It’s so amazing how quickly babies grow, [and] how the skull just fixed itself with the helmet. I would recommend it for anybody who can do it” (Pp10). Others focused on the noninvasive nature of the treatment with one caregiver stating: “we were lucky because he was diagnosed early so we sort of had the choice between the [open] cranial vault remodeling, which would not require a helmet and a less invasive surgery [ESC], but with a helmet…we were grateful for the helmet [because] it meant he had to have a less invasive surgery” (Pc13) and another remarking that “[the other option] the doctor [mentioned] was doing surgery and the helmet just seemed [like] the least invasive” (Pp7).

Caregiver participants also felt strongly about offering advice to future caregivers who might be undergoing HT with their wards. Some of them describe the process as a “short-term struggle for a long-term gain” (Pp8), stating that they “would recommend it for anybody who can do it” (Pp10). Table 3 summarizes caregiver participants’ advice to other caregivers.

Table 3.

Participants’ advice to other caregivers

Considerations before starting HT	For patients with positional plagiocephaly, caregivers should weigh the child’s age, head shape severity, and projected outcomes against efforts and commitment to purse HT Consider whether the therapy is financially feasible Ask if financial support is available
Helmet care and hygiene	Clean the helmet as needed to avoid odor. Try using a toothbrush to get in-between smaller areas Take breaks – air out the helmet and check for redness or sores Wash the child’s head every night to get rid of the sweat and smell from wearing the helmet all day
At visits	Adjustment visits can be long, make sure to plan your day Advocate for your child’s comfort – if you feel like something is not right with the helmet, let the clinicians know right away
Child’s comfort and experience	During summer days, use an adult size hat to place over the helmet to protect the child’s skin underneath To avoid overheating, adjust clothing and remove layers as needed Buy a fan for the stroller to keep the child cool Personalize the helmet by adding stickers or bows Allow the child to see themselves in the mirror wearing the helmet. This makes the experience more playful and interactive
Words of encouragement	Find caregivers who are in the same situation or have completed HT. This support system can be helpful to reduce stress and anxiety and provide you with additional resources or tips Keep going, stay committed, and you will see great results Overwhelming experience at first, but you will realize it is the best decision for your child You are not alone, many families go through it It is a short-term struggle for long-term gain

Discussion

This study uniquely characterizes the burden of care for caregivers of children undergoing HT for craniosynostosis following ESC. Using a phenomenological qualitative approach, we were able to generate a rich understanding of the caregivers’ experience with HT. By comparing the experiences of caregivers of children with plagiocephaly to the experiences of caregivers of children with craniosynostosis treated with ESC, this study showed there were no differences between groups, despite different motivations for choosing HT. This suggests that the understanding of the caregivers’ experience with HT presented here is generalizable. All participants were satisfied with the experience to the extent that they would even repeat again if needed. This information may ultimately inform future caregiver decision-making when navigating treatment options for the management of either plagiocephaly or single-suture craniosynostosis and may aid healthcare providers in employing truly informed consent for treatment options that involve HT.

Caregivers in our study described five domains of burden of care, including emotional, cognitive, physical, psychosocial, and financial domains. These domains of caregiver burden, as well as the additional themes identified by this study, align with the previous literature around caregiver burden [24], further emphasizing the impact of patients’ illness on caregivers. Furthermore, parental satisfaction with HT expressed in this study is similar to previous studies on HT for plagiocephaly where parents report satisfaction with their child’s long-term head shape, stating that they would choose the same treatment again if necessary [13].

Subsequently, caregivers in this study identified the physical burdens of care to be the most onerous, with more than half of the participant experiencing this burden of care, although no participants in the study found the burdens daunting enough to induce early treatment cessation or affect participation in the study. Included under the physical burden of care domain is cleaning and daily tasks related to helmet care, time added to regular daily routines, temperature regulation difficulties while wearing helmets, minor adverse events like rashes, and time commitment. About one-quarter of the caregivers in this study expressed concerns related to time commitment of adjustment visits, which is consistent with the findings of Kluba et al. where a similar proportion of caregivers of children with plagiocephaly undergoing HT listed time-consuming drives to the clinic appointments as a significant burden [11]. Similarly, the minor adverse events reported in this study – heat rashes, pressure sores, itchiness – are consistent with previous studies reporting adverse events with HT [25]; however, in this study, given the minor nature of the events, they did not serve as a deterrent to adherence with therapy. Nevertheless, it is important to note that minor skin-related adverse events like pressure sores, skin irritation, or rashes can increase the burden of care for caregivers. Additionally, if not recognized and treated early, they can worsen, leading to increased time out of the helmet (which may impact total duration and efficacy of HT), and require further visits to the hospital for additional helmet adjustments and/or consultation with dermatology in the case of severe eczematous reactions. To minimize the impact of skin-related adverse events, we have developed the following protocols at the Hospital for Sick Children.

Patients are seen by the plastic surgery team 1-week postoperatively to ensure the incisions are healing well. At this visit, the head is scanned at orthotics in preparation for the HT. Suture care – consisting of washing the incision twice daily with soap and water and applying Vaseline – is re-emphasized.

At 2-weeks post-op, caregivers begin scrubbing the incision with a terry-cloth washcloth to encourage the ends of the resorbable sutures to fall out, minimizing the risk of suture reactions. In addition, caregivers pick up the first helmet and begin HT. At 2-weeks post-op, the incisions are largely healed and can withstand any potential pressure from the helmet.

Caregivers are instructed to clean the helmets once daily with mild soap or diluted isopropyl alcohol, wipe clean with a damp cloth, and allow the helmet to dry completely before donning. They are also instructed to look for areas of pressure that do not resolve within 10 min after helmet removal (some redness is desired as it shows there is adequate pressure to reshape the head, but the pressure must resolve in 10 min to avoid pressure injuries).

In the event of heat rash, caregivers are instructed to give frequent breaks from the helmet and reduce clothing. In the event of allergic or eczematous response to the helmet materials, a stockinette can be fashioned to create a barrier between the skin and the helmet or the lining interface of the helmet can be modified. If persistent or severe, patients are referred to dermatology in an effort to mitigate skin-related complications and resume helmet use as soon as possible.

Furthermore, in contrast to most non-Canadian based studies [11, 19, 26], this study found that the financial domain was the least burdensome, especially in terms of direct costs of the helmet and HT. As previously stated, in our study, most participants (79%) reported having health insurance policies that fully reimbursed the costs of HT. Participants whose child had craniosynostosis without health insurance were covered through the Hospital for Sick Children. In contrast, USA-based studies place financial burden higher as the direct cost of HT ranges from USD 1,500 to USD 3,000 [26], with individuals without insurance coverage bearing the brunt of the cost. In a study across 21 US states, it was recently revealed that Medicaid insurance was associated with lower craniometric correction in plagiocephaly as Medicaid may pose restrictive insurance authorization requirements such as a specialist referral or longer trial of conservative therapy prior to initiating HT, which could delay access to care [19]. Similarly, Kluba et al. [11] found that families of children with plagiocephaly in Germany experienced significant financial burdens with 45.1% of caregivers having to cover the costs of HT themselves and 36.1% reporting conflicts with getting reimbursements from their insurance providers. The limited financial burdens identified in this study must be taken in context: for the plagiocephaly group, there is likely a selection bias in which with families with extended health benefits or ample financial means are more likely to pursue HT than families without these advantages. For the craniosynostosis group, direct costs of HT not covered by the caregiver’s extended health benefits were covered by the Hospital for Sick Children. This policy was created following an internal analysis that demonstrated a CAD 20,000 cost-saving to the healthcare system when ESC was compared to open cranial vault remodeling.

Nevertheless, indirect costs seem to be shared similarly across regions with costs ranging from accessory care products like sensitive skin shampoo and head products to costs incurred during visits like parking, gas, time off work, and babysitting services. In our study, these expenses weighed more heavily on caregivers than the cost of the helmet because no compensation was provided for indirect costs – mainly because they are varied and difficult to standardize.

Limitations

There are several limitations in this study. First, the study was carried out at a single site – the Hospital for Sick Children – with a small study sample. This may limit the transferability of the study data; however, the sample included a diverse population (Table 1), and data collection and analysis were conducted until thematic saturation was reached. In addition, while interviews were conducted after the clinical visit (to avoid bottlenecks in clinical spaces and additional charges for childcare and parking), recall bias was minimized by interviewing participants while their child was undergoing HT or had recently completed the treatment (within 2 months). Second, while the focus of the study title may allude to a negative experience by virtue of the term “caregiver burden,” there were positive aspects to HT that caregivers experienced and voluntarily reported, suggesting a minimal impact of the study title on participants’ perspectives. Finally, although qualitative methodology provides a way to understand this complex, multifaceted experience better – especially relating to the psychosocial impacts on caregivers – it might further illuminate our understanding of this experience to further affirm the findings with quantitative analyses; however, quantitative measures for caregiver burden do not always capture the multifaceted nature of these burdens and thus should be informed by qualitative studies first.

Conclusion

HT used in the treatment of plagiocephaly and craniosynostosis following ESC is associated with varying degrees of caregiver burden in the following domains: emotional, cognitive, physical, psychosocial, and financial. Although the physical burdens of care are the most onerous, none of the caregivers found them too onerous to complete therapy nor did they regret choosing HT as a treatment option. Additionally, caregivers report overall satisfaction with the process, stating willingness to repeat the treatment with subsequent children if required. The results of this study may inform future studies that quantify caregiver burden throughout the HT process to provide more information for providers and caregivers navigating treatment options for both plagiocephaly and craniosynostosis.

Statement of Ethics

Ethics approval was received from the Hospital for Sick Children’s (SickKids) Research Ethics Board (REB). In addition, the procedures used in this study adhere to the tenets of the Declaration of Helsinki. All participants in this study provided written informed consent after they were informed of the study purpose, procedures, responsibilities, risks, benefits, and the choice to withdraw. This was sought prior to the commencement of interviews. No participants in this study were under the age of 18 years; participants were all legal guardians of their wards whose experiences with helmeting were discussed.

Conflict of Interest Statement

The authors declare that they have no conflict of interest relevant to the content of this article.

Funding Sources

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Furthermore, no funding was received to assist with the preparation of this manuscript. HT for select patients was supported by the Craniofacial Program at the Hospital for Sick Children, Toronto, ON, Canada.

Author Contributions

Authors T.E. and A.H. transcribed, coded, and analyzed interviews and created initial drafts of the manuscript. Authors T.E., J.N.R., and E.B. edited initial manuscript drafts to produce the final versions of the manuscript. Authors J.N.R. and A.H. designed the study, sought ethics approval, and performed initial data collection. Authors J.N.R., A.V.K., and C.R.F. provided supervisory guidance in methodology, analysis, and manuscript editing. All the authors reviewed and approved the final version of the manuscript.

Funding Statement

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Furthermore, no funding was received to assist with the preparation of this manuscript. HT for select patients was supported by the Craniofacial Program at the Hospital for Sick Children, Toronto, ON, Canada.

Data Availability Statement

The data supporting findings of this study are not publicly available as they contain information that could compromise the privacy of research participants. However, upon request, data are available in a de-identified format from the corresponding author (J.N.R.).