Most of the evidence describing pain management practices in infants is in the neonatal intensive care unit (NICU) environment. Although both nurses and parents report positive perceptions regarding the pain-reducing effectiveness of breastfeeding and skin-to-skin contact for infants [25,26], uptake and sustained implementation of these interventions in clinical practice has been limited [25,27], with less than half of the infants receiving any form of pain-relieving treatment during tissue-breaking procedures [27]. Common reasons for not using these interventions include lack of knowledge, stress and anxiety, gatekeeping and parent exclusion, and challenges associated with the physical environment [25].

Lack of knowledge about pain management in infants has been identified as a barrier to evidence-informed pain care [28-30]. Parents reported feeling apprehensive about participating in pain relief methods as they were not informed of pain in infants and nonpharmacological pain management approaches, including skin-to-skin contact and breastfeeding [24]. Parents reported that resources such as educational pamphlets, videos, workshops, or active counseling as educative initiatives for parent-led pain management in infants would be useful to enhance their awareness of the importance and use of parent-led pain-reducing strategies [28,31,32]. Health care providers, including nurses and physicians, may lack the communication skills needed to effectively relay information about pain in infants to families under their care [33]. A study found that educational pamphlets were used but only as part of the patient’s discharge package [32]. Parents who lacked knowledge regarding parent-led pain management interventions in infants stated that to be appropriately educated, the health care team needed to improve on how and when information was given to them [25].

Stress and anxiety are also barriers to parental involvement in pain management in infants [28,29]. Parents who lack knowledge of pain relief interventions have been found to feel anxious and uncertain about their ability to provide pain relief [29]. Multiple studies have shown that parents in particular found it stressful to be present during painful procedures, either because of their own phobia and fear of needles or because it was emotionally very difficult to watch their infant in pain [28-30].

The attitudes and behaviors of health care providers influence the abilities of parents to participate in parent-led pain management in infants [30]. Health care providers have reported feeling responsible for pain management, acting in a gatekeeper role by deciding who provides pain relief measures and how they are provided [28-30]. Health care providers may exclude parents from participating in painful procedures, because they underestimate the abilities of the parents or feel as though they are protecting the parents from fear or anxiety [28]. Some studies have shown that staff members excluded parents from being involved in pain relief during painful procedures, because their presence was seen as an additional stressor to the health care provider [29,31]. 

Studies in this area have been conducted in NICU settings. The physical environment of the NICU acts as a barrier to parent-led pain management in infants [28,29]. Parents may struggle to find their role as caregivers in restrictive medicalized environments [28]. Technology and equipment, including incubators, act as barriers that limit the ability of parents to participate in pain relief measures [29]. The NICU has been described as lacking physical space for parents to be present [28] and has policies that prevent them from being present during reports or medical rounds, thus restricting access to their baby [29].

The main facilitator of parent-led pain management in infants identified is the motivation of parents to be active participants in pain relief strategies and their eagerness to be educated on the subject [28-30,34]. Parents of infants in the NICU found that seeing their infant in pain increased their desire to be involved in their care and pain reduction [29]. Health care providers who showed a positive attitude toward parental involvement in pain management in infants and who empowered parental education, influenced the motivation of parents to participate in strategies of parent-led pain management in infants [28,29,31]. Parents were more likely to be involved in pain management in infants when they wanted knowledge about pain in infants and felt responsible for the well-being of their infant [28].

Although studies have identified the physical environment as a barrier to parent-led pain management in infants, some studies have shown that it is also a facilitator. Parents felt more comfortable participating in pain relief strategies when the physical environment was family-friendly [28]. Parents also stated that private rooms and kangaroo care chairs promoted participation [29]. 

Access to educational tools and information, as well as open communication between parents and staff about pain management in infants has been reported to promote parent participation [28,34]. Parents who had access to educational tools, such as pamphlets or videos, felt more prepared to participate in parent-led pain management [29]. A study suggested multiple ways of disseminating this information, including during birthing or parenting classes, in hospitals or physician’ offices, and in waiting rooms [34]. Parents were also more likely to participate in parent-led pain management, if the information used to educate them was obtained from a credible source [34]. Family-centered care approaches, in which health care providers partnered with parents on pain management in infants, promoted parental participation [31]. Health care providers who communicated appropriate timing and tasks for parent-led pain management enabled parents to be open to participating in pain relief [29].

Our setting includes regional hospitals and community-based contexts that provide perinatal and infant care in northeastern Nova Scotia, Canada. To obtain diverse perspectives, we will use stratified purposive sampling [36,42] of hospital and community-based health care providers (eg, acute care nurses, public health nurses, family practice nurses, acute and primary care physicians or nurse practitioners, midwives, obstetricians, and laboratory technicians), clinical leaders (eg, lactation consultants), administrators and policy makers (eg, program managers), and families who have used hospital or community perinatal services in northeastern Nova Scotia in the last 12 months. Face-to-face, semistructured, in-person interviews with each consenting participant will be conducted. We will aim to recruit approximately 20 to 30 [36,42,43] participants to obtain in-depth data related to the implementation of parent-led pain care. The large sample size was selected based on the heterogeneity of the target sample. To ensure that we have adequate representation and achieve data saturation across diverse health systems and experiences of parent participants, we will use qualitative sampling criteria [44] (which include evaluation of data variations, contraindications, and clarity) to determine if additional targeted recruitment of specific participant groups and exploration of specific experiences is needed to achieve depth and richness in the data. To recruit health system participants, a recruitment email containing study details and an invitation to participate in the study will be circulated through key research team partners and networks. For parent participants, electronic recruitment posters will be circulated via social media, and hard copy recruitment posters will be distributed through hospital and community antenatal care contexts across the province. We will strategically and purposively sample participants who identify as members of equity-seeking groups with diverse intersections of identity, represented across sex, gender, ethnicity, socioeconomic status, immigration or migration status, sexual orientation, ability status, and geography.

The TDF domains [36,37] were used to develop the semistructured interview questionnaires (Textboxes 1 and 2) and guide the analysis of participant interviews. The study interview guides were piloted with a parent partner and a health care provider partner to ensure the appropriateness and adequacy of the interview questions and the feasibility of completing the interview questions within a 60- to 90-minute time frame. Minor revisions to both interview guides were made based on partner feedback. One-on-one semistructured interviews are completed with each consenting participant.

The transcriptions of audio-recorded interviews will undergo inductive-deductive qualitative content analysis [45-47] using NVivo (QSR International) qualitative data analysis software [48]. We will specifically use an intersectionality tool developed for use alongside the TDF [49] to support sex- and gender-based+ analysis. This tool includes intersectionality prompts for each of the 14 TDF domains to be used in participant interviews and data analysis to draw out information on the influences of social factors and structures of power on the implementation of parent-led pain care in infants [49]. First, 2 reviewers (BB and at least one other author) will deductively categorize [46,47] participant responses in the interview data into the 14 TDF domains [37]. Second, principles of inductive qualitative content analysis [46,47] will be used to generate categories and subcategories of salient barriers and facilitators related to the implementation of parent-led pain care within each of the relevant TDF domain categories [46]. To do this, participant responses will be read multiple times to identify the main points being addressed in relation to the TDF domains. Responses will be read line by line to generate codes, and these codes will be synthesized into higher level categories of barriers and enablers relevant to each of the TDF domains. Strategies to ensure trustworthiness in qualitative research [50,51] and implementation studies [52] will be used. Such approaches include clearly documenting and reporting the analysis process [45,52] and the culture, context, and selection and characteristics of the included participants [42,45,50,52]. Research participants will also be asked to provide feedback on the findings of the analysis (during the advisory committee meetings in phase 2) to ensure that they accurately represent experiences [45,50,51].

It is anticipated that the data from this diverse group of clinicians, clinical leaders, administrators, policy makers, and parents will highlight key behavioral determinants for interventions to support the use of parent-led pain care in infants which are in practice in hospitals and in the community.

Phase 2 of this study will build on the findings of phase 1 to develop theoretically robust, empirically tested implementation interventions aimed at supporting the identified facilitators and overcoming the barriers to the use of parent-led pain care in infants. These interventions will be tested in subsequent studies. To do this, we will use the BCW [38], a systematic guide that pairs with the TDF to design tailored implementation interventions. We will implement a 2-step approach to the intervention design.

First, our research team will review the findings from phase 1 interviews alongside the BCW. The BCW provides 9 intervention functions (eg, education and environmental restructuring) that provide evidence for effectively changing behaviors in each TDF domain. We will map the relevant barriers and facilitators identified by participants within each of the TDF domains onto the intervention functions. Next, the BCW will be further used to map the intervention functions onto key “active ingredient” intervention components to create tailored interventions that target the identified barriers and facilitators in participant interviews.

Next, we will hold two 3-hour meetings with an advisory committee of several key administrative, clinical, and parent stakeholders who participated in phase 1 interviews to critically review the findings from phase 1 and the implementation interventions identified in phase 2(a). We will strategically invite committee members to ensure diverse and intersecting representation based on sex, gender, ethnicity, socioeconomic status, immigration or migration status, sexual orientation, ability status, and geography, ensuring a minimum of 2 parent stakeholders.

First, the research team will present the advisory committee the findings from phases 1 and 2(a) as a foundation for the refinement of implementation strategies. Second, a facilitator will lead the advisory committee to critically review the findings from phase 1 and the implementation interventions identified in phase 2(a) using the affordability, practicability, effectiveness and cost-effectiveness, acceptability, safety, and equity intervention criteria [38]. All discussion details will be documented by the study research assistant, consistent with the intervention development guidelines [52]. Strategies will be used to encourage authentic engagement and participation from all members of the advisory committee [53]. Such strategies will include using targeted questions for specific participant groups (ie, clinical stakeholders and parent stakeholders) to ensure feedback is obtained from all participants. In addition, small breakout groups will be used to facilitate targeted discussions, and participants will be encouraged to share verbal or written individual feedback or notes after the meeting has ended, if they are more comfortable doing so [53]. This discussion will help identify intervention feasibility and options for intervention delivery in different care environments and provide an opportunity to identify and refine details of optimal intervention implementation (eg, content, settings, recipients, providers, intensity, duration, and fidelity).

Following the completion of phase 2, we will have co-designed theoretically informed implementation interventions that have evidence for effectively supporting evidence implementation. These implementation interventions can subsequently be pilot-tested and experimentally applied in future studies to support the use of parent-led pain care for infants in both hospital and community contexts.