Pain in infants is a common concern identified by parents.1-3 Routine postpartum care for infants in early life requires them to endure painful procedures. These could include routine heel lancing to collect blood specimen, intramuscular injections to provide vitamin K or immunizations, intravenous catheter insertion, suctioning, nasogastric tube placement or tape removal.4 Despite widespread evidence supporting proper pain management, infants often receive little to no pain relieving treatments.4 In addition to immediate pain and stress responses, impairments in later neurodevelopment and behavior can occur as a result of untreated pain.5-13 Parents recognize that procedural pain is an issue and have demonstrated interest in accessing information on all aspects of infant pain management.2 However, while research has shown that parents can reduce their infant's pain during procedures by engaging in skin-to-skin contact or breastfeeding,14-16 parents may not be aware of their role in pain management. Parents with infants in the neonatal intensive care unit (NICU) have been found to search the Internet specifically on how to help their children with pain relief.3 However, Dol et al. found that only 5.1% of websites accessible worldwide through Google had any information on infant pain.17 In a similar review recently completed by our team, only 11.1% (n = 2) of mobile health (mHealth) applications (apps) targeted at parents of infants receiving care in the NICU included any information on pain.18 Although there have not been similar reviews targeted at parents of full-term infants conducted to date, it is likely there are also few websites or mHealth apps that discuss infant pain management with this population, leaving parents with little opportunity to access information on infant pain on their own.
Digital technologies have been gaining significant attention in the health sector over the past two decades. The term electronic health (eHealth), first identified in 1999, describes an expansive field emerging from health informatics that employs information and communication technologies in healthcare delivery and management.19,20 eHealth interventions could be designed as communication or educational platforms or a combination of both.19 eHealth interventions can be implemented in a variety of ways, such as video conferencing, web cameras, push technology, mHealth apps, web-based platforms, videos, interactive training, hands-on direct simulation, Internet, short message service (SMS) or text messaging, or computer programs.20 There has been a shift in focus for healthcare systems, with eHealth resources increasing in popularity due to their benefits of widespread accessibility, promotion of health autonomy and efficient information sharing.21 For the same reasons, healthcare consumers, including parents, have shown a preference in accessing health information through the Internet despite knowing the potential for receiving poor quality and inaccurate information.17,22
As eHealth has increasingly been utilized for providing education and support, it has been widely recognized as a beneficial educational tool for various aspects of parenting.3,23,24 Having nearly unlimited access to eHealth resources allows parents the flexibility to learn at their own pace.25 Recognizing this, parents frequently use popular search engines or social media on the Internet to access information regarding their infant's health.3,26 In a recent study exploring American mothers’ perceptions and use of media for health information, mothers unanimously reported searching Google for advice on even their child's most critical health concerns prior to contacting a credible health resource.27 Similarly, parents with infants in the NICU have been found to prefer accessing the Internet with their smartphone when seeking information about their infant's health.3,28,29 Our team recently conducted a systematic review evaluating the quality and reliability of health content in websites accessible from Google that were targeted at NICU parents. The findings from this review were consistent with previous literature on general health topics, that is, the included websites were deemed to have poor to moderate quality of health information based on standardized assessment measures of reliability and credibility.17 These findings were echoed in a similar systematic review of mHealth apps targeted at parents of infants in the NICU.18 Given the significant variability in quality of information on the Internet, paucity of information related to parental participation in infant pain, and notable interest by parents, evidence-based eHealth resources are needed to better equip parents with the knowledge and skills necessary to enhance effective parental-led pain management practices overall.
Several evidence-based syntheses have been conducted since 2016 in an attempt to critically assess the quality and impact of eHealth resources specifically targeted to parents of infants.17,18,23,30,31 Although eHealth education specifically targeting pediatric pain is a rapidly emerging field, few of the existing reviews evaluated interventions on this topic.32-34 Farkas et al. conducted a scoping review of educational videos about pediatric needle-related pain management available through YouTube.35 Over 64% of reviewed videos were targeted at parents, with most related to infant or toddler needle-related pain management; however, the effectiveness of these interventions was not explored.35 In a multi-phased review evaluating pain-related mHealth apps, a total of 47 publications reporting on 34 pain-related mHealth apps were found, with 64.7% of those apps targeting adult pain.36 Interestingly, none of the mHealth apps reported in the 47 publications were available for downloading in five leading app stores across Canada, Spain or the United States, despite 283 other pain-related apps having been identified in these stores.36 Thus, there appears to be a significant disconnect between empirical evaluation and accessibility of mHealth interventions. This limitation has been found across various studies reviewing mHealth apps.18,37-40 However, with a greater emphasis on intervention sustainability, there is growing evidence to support that pain-related eHealth intervention developers are recognizing the importance of knowledge translation activities, including evaluations with end users on eHealth satisfaction and behavior change (e.g. usability testing and effectiveness trials).41-43
Outside of the topic of pain, in a systematic review evaluating general eHealth interventions targeted at parents with infants in the NICU, parents reported eHealth interventions to be acceptable and that they actively used these resources within the NICU setting.30 Despite aiming to gather information on a variety of parental and neonatal outcomes, there was limited evidence assessing the impact of eHealth interventions on neonatal outcomes provided within the included studies.30 Similarly, in a scoping review evaluating parent-targeted general eHealth educational interventions in the NICU, Anwar Siani et al.31 found little evidence to address the impact of eHealth resources on neonatal outcomes; however, there were improvements identified in various parental outcomes, including satisfaction, confidence and knowledge uptake. Although there may be challenges gathering empirical evidence related to parent-targeted eHealth educational interventions on infant procedural pain management, this systematic review is necessary to build a knowledge base and further support the call for scientific support of eHealth interventions.
The current review seeks to provide a comprehensive analysis of the impact of parent-targeted eHealth educational interventions about infant procedural pain management on both parental outcomes (mental health outcomes, knowledge utilization outcomes and parental involvement in care outcomes) and infant outcomes (morbidity outcomes, pain outcomes and health system outcomes). Although recent reviews by Dol et al.30 and Anwar Siani et al.31 noted that studies reported insufficient information on neonatal outcomes, the current review may be more likely to retrieve studies that evaluate the influence of eHealth resources on infant outcomes as the topic of the interventions will specifically address infant procedural pain as an indicator.
While evidence syntheses have been conducted on some aspects of eHealth related to parenting or the infant population broadly,23,30,31 there have been no systematic reviews concerning parent-targeted eHealth educational interventions specific to infant pain and pain management. The following databases/sources were searched for existing systematic reviews on the topic and no review was located: PROSPERO, PubMed, Cochrane and JBI Database of Systematic Reviews and Implementation Report. There is a growing body of literature supporting the need for parent-targeted eHealth interventions to disseminate infant procedural pain-related information. Therefore, we believe this review will provide a timely evaluation of empirically evaluated resources and their influence on vital parental and infant outcomes. This review also aims to inform future knowledge translation initiatives seeking to increase the use of parent-led pain management strategies, thus an evaluation of the impact of current eHealth resources is imperative.
The objective of this review is to determine if parent-targeted eHealth educational interventions for infant procedural pain and pain management impact parental and infant outcomes. Specifically, the review questions are:
- i) Do parent-targeted eHealth educational interventions for infant procedural pain and pain management impact parental stress or anxiety, self-efficacy, knowledge, attitudes, eHealth usage, eHealth acceptance and involvement with infant pain management?
- ii) Do parent-targeted eHealth educational interventions for infant procedural pain and pain management impact bio-behavioral pain response, neonatal morbidity, feeding and length of stay in hospital?
The review will consider studies that include eHealth educational interventions targeted at expectant parents, parents or primary caregivers (excluding healthcare professionals or community health workers) of infants. Infants from birth to one year of age will be included in this review as well as parents of infants born preterm or full term to ensure a comprehensive evaluation of all parent-targeted eHealth educational interventions specifically about infant pain management. As the focus of this review is to evaluate parent-targeted educational interventions, studies or interventions targeting healthcare providers alone will not be included.
This review will consider studies that evaluate eHealth educational interventions targeted at parents, which is defined as biological, adoptive or foster parents, during pregnancy or when the infant is one year of age. eHealth educational interventions include, but are not limited to, mobile applications, web-based platforms, videos, interactive training, hands-on direct simulation, Internet, SMS or text messaging and computer programs. The review seeks to focus specifically on parents’ experiences with infant procedural pain, thus interventions with content related to pain management for children greater than one year will be excluded. Studies that evaluate interventions that are solely for information collection (e.g. data collection) will also be excluded as these do not contain any educational content.
This review will consider studies that compare the intervention to any comparator, including but not limited to, standard care (e.g. education provided to parents verbally by a healthcare provider) or a control group receiving printed educational material.
To understand if parent-targeted eHealth educational interventions impact parents and infant outcomes, this review will consider studies that evaluate the following outcome measures.
- Parental stress and anxiety, defined as parents’ experience of stress and/or anxiety, measured by standardized questionnaires (e.g. Parental Stressor Scale: NICU or Perinatal Anxiety Screening Scale).44,45 If stress and anxiety outcomes are assessed by non-standardized methods, the outcomes will be synthesized narratively in the final report.
- Parental self-efficacy or confidence, defined according to each study, measured by self-report questionnaires or other measures as reported by each study (e.g. Karitane Parenting Confidence Scale).46
- Parental knowledge, defined according to each study, measured by self-report questionnaires or other measures as reported by each study (e.g. pre/post knowledge tests).
- Parental attitudes, defined according to each study, measured by self-report questionnaires or other measures as reported by each study (e.g. Parent Attitudes about Infant Nociception).1
- eHealth educational intervention usage, defined as frequency of use of intervention by the parent, measured by the number of times the intervention is used during the study (e.g. self-report of intervention utilization).
- Parental acceptance of eHealth educational intervention, defined as parental satisfaction with the eHealth intervention, measured through surveys related to feasibility (e.g. Technology Acceptance Model).47
- Involvement in parent-led pain management, defined as a parent providing pain relief (e.g. breastfeeding, skin-to-skin contact) or advocating for pain relief (e.g. oral sucrose) during procedures, measured by observation, self-report or other measures, as reported by each study.
- Infant pain response, defined as response to an invasive procedural (i.e. during procedure and/or recovery period), as measured by at least one of the following:
- - Validated composite biobehavioral pain scores, including a combination of behavioral, physiological and contextual indicators (e.g. Premature Infant Pain Profile).48,49
- - Behavioral indicators (audible cry duration in seconds or milliseconds; proportion of time of total procedure that has predefined facial actions reflecting grimace, e.g. brow bulge, eye squeeze, nasolabial furrow; proportion of time that has predefined body movements, e.g. limb thrashing, fisting, finger splaying, limb and torso flexion).
- - Physiological indicator changes from baseline in heart rate, respiratory rate, oxygen saturation/transcutaneous oxygen tension and brain-based physiological measures. These measures should be reported before, during and after the procedure.
- - Hormonal indicators (salivary cortisol, serum beta-endorphins) obtained from body fluids (saliva, serum) with description of analyses, e.g. radio-immune assay techniques.
- Neonatal morbidity, defined and reported according to each study (e.g. infection, need for readmission).
- Type of feeding, defined as baby being breastfed or formula fed, measured by self-reports or observation.
- Length of stay, defined as total number of days spent in hospital.
Types of studies
This review will consider both experimental and quasi-experimental study designs including randomized controlled trials, non-randomized controlled trials, before and after studies, and interrupted time-series studies. In addition, analytical observational studies including prospective and retrospective cohort studies, case-control studies and analytical cross-sectional studies will be considered for inclusion. This review will also consider descriptive observational study designs including case series, individual case reports and descriptive cross-sectional studies for inclusion. Consistent with the emergence of eHealth and with many reviews evaluating eHealth-related interventions, only studies published after 2000 will be included. Studies published in English will be included.50
This systematic review will be conducted in accordance with the JBI methodology for systematic reviews of effectiveness evidence.51
The search strategy aims to find both published and unpublished studies. An initial limited search of PubMed was conducted to identify keywords and subject headings commonly used to index articles within this field of study. This informed the development of a full search strategy by a librarian, detailed in Appendix I. A detailed search strategy tailored to each database will be utilized for each of the following databases: PubMed, CINAHL, PsycINFO, Embase, Scopus, Web of Science and SciELO. Results will not be limited to academic journal articles only, as conference abstracts and theses will also be included in order to ensure both published and unpublished search results are returned. The ProQuest Dissertations and Theses Global database will also be searched for additional unpublished studies. Finally, forward and backward searching of the all studies selected for critical appraisal will be conducted to identify any additional studies for consideration.
Following the search, all identified citations will be collated and uploaded into Covidence (Covidence, Melbourne, Australia) and duplicates removed. Titles and abstracts will then be screened by two independent reviewers for assessment against the inclusion criteria for the review. Studies that meet or could potentially meet the inclusion criteria will be retrieved and assessed in detail against the inclusion criteria in Covidence for the full text screening stage. Full-text studies that do not meet the inclusion criteria will be excluded, and reasons for exclusion will be provided in an appendix in the final systematic review report. Any disagreements that arise between the reviewers regarding their assessment on study eligibility will be resolved through discussion, or with a third reviewer. The results of the search will be reported in full in the final report and presented in a PRISMA flow diagram. Studies included after full text screening will be imported into the JBI System for the Unified Management, Assessment and Review of Information (JBI SUMARI; Joanna Briggs Institute, Adelaide, Australia) where they will undergo a process of critical appraisal and data extraction.
Assessment of methodological quality
Selected studies will be critically appraised by two independent reviewers at the study level for methodological quality in the review using standardized critical appraisal instruments from JBI.51 Any disagreements that arise between the reviewers regarding their assessment on study quality will be resolved through discussion, or with a third reviewer. Following critical appraisal, studies that do not meet a certain quality threshold will be excluded. The decision to exclude will be based on a score less than 50% on the applicable critical appraisal instrument. Any studies below this cut-off will be described narratively in the final report; however, their data will not be included in the synthesis.51
Data will be extracted from papers included in the review using the standardized data extraction tool available in JBI SUMARI by two independent reviewers.51 The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer. Authors of papers will be contacted to request missing or additional data where required.
Papers will, where possible, be pooled in statistical meta-analysis using JBI SUMARI. Effect sizes will be expressed as either odds ratios (for dichotomous data) or mean differences (for continuous data), and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard chi-squared and I-squared tests. The choice of model (random or fixed effects) and method for meta-analysis will be based on the guidance by Tufanaru et al.51 Subgroup analyses will be conducted where there are sufficient data to investigate eHealth educational interventions delivered in the prenatal period alone, postpartum period alone, or across the perinatal period up to when infant is one year of age. Additionally, subgroup analysis will be conducted comparing infants born preterm and full-term, and between method of implementation and method of intervention (e.g. website versus mHealth app). Where statistical pooling is not possible, the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate. A funnel plot will be generated to assess publication bias if there are 10 or more studies included in a meta-analysis. Statistical tests for funnel plot asymmetry will be performed where appropriate.
Assessing certainty in the findings
A Summary of Findings will be created using GRADEpro (McMaster University, ON, Canada). The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach for grading the quality of evidence will be followed.52 The Summary of Findings will present the following information where appropriate: absolute risks for treatment and control, estimates of relative risk, and a ranking of the quality of the evidence based on study limitations (risk of bias), indirectness, inconsistency, imprecision and publication bias. The following outcomes will be included in the Summary of Findings: parental stress and anxiety, parental self-efficacy, eHealth educational intervention usage, eHealth intervention acceptability, parental involvement in pain management, and infant bio-behavioral pain response, as appropriate.
BR is supported by a Doctoral Award through the Canadian Institutes of Health Research, Dalhousie University School of Nursing Doctoral Scholarship and Helen Watson Memorial Scholarship, the Nova Scotia Health Research Foundation Scotia Scholars Award, BRIC NS Student Award, Canadian Nurses Foundation, and Chez NICU Home Doctoral Scholarship.
MCY is supported by a Canadian Institutes of Health Research New Investigator Award.
Appendix I: Search strategy
PubMed (04-02-19): 476 records returned
(“pain”[MH] OR “pain management”[MH] OR “pain measurement”[MH] OR pain[tiab])
(“infant”[MH] OR infant [tiab] OR “low birth weight”[tiab] OR infan∗[tiab] OR newborn∗[tiab] OR new-born∗[tiab] OR perinat∗ [tiab] OR neonat∗ [tiab] OR baby [tiab] OR babies [tiab])
(“education” [MH] OR “teaching” [MH] OR “learning” [MH] OR educat∗[tiab] OR teach∗[tiab] OR learn∗[tiab] OR elearn∗ [tiab] OR e-learn∗ [tiab] OR ehealth [tiab] OR e-health [tiab])
(“parents”[MH] OR parent∗[tiab] OR “mothers”[MH] OR mother∗[tiab] OR “fathers”[MH] OR father∗[tiab])
CINAHL (04-02-19): 194 records returned
((MH “Pain+”) OR (MH “Pain Management”) OR (MH “Pain Measurement”))
((TI “low birth weight” OR AB “low birth weight” OR TI Infan∗ OR AB Infan∗ OR TI newborn∗ OR AB newborn∗ OR TI new-born∗ OR AB new-born∗ OR TI perinat∗ OR AB perinat∗ OR TI neonat∗ OR AB neonat∗ OR TI baby OR AB baby OR TI babies OR AB babies))
((MH “education+” OR TI educat∗ OR AB educat∗ OR TI teach∗ OR AB teach∗ OR MH “learning+” OR TI learn∗ OR AB learn∗ OR TI ehealth OR AB ehealth OR TI e-health OR AB e-health OR TI elearn∗ OR AB e-learn∗))
((MH “parents” OR TI parent∗ OR AB parent∗ OR MH “mothers” OR TI mother∗ OR AB mother∗ OR MH “fathers” OR TI father∗ OR AB father∗))
NOTE: LIMITED TO 20000101-20190431
PsycINFO (04-02-19): 29 records returned
(SU pain OR SU “pain management” OR SU“pain measurement”)
(TI (educat∗ OR teach∗ OR learn∗ OR ehealth OR e-health OR elearn∗ OR e-learn∗) OR AB (educat∗ OR teach∗ OR learn∗ OR ehealth OR e-health OR elearn∗ OR e-learn∗))
(TI (parent∗ OR mother∗ OR father∗) OR AB (parent∗ OR mother∗ OR father∗))
(TI (“low birth weight” OR infan∗ OR newborn∗ OR new-born∗ OR perinat∗ OR neonat∗ OR baby OR babies)
AB (“low birth weight” OR infan∗ OR newborn∗ OR new-born∗ OR perinat∗ OR neonat∗ OR baby OR babies)
NOTE: LIMITED TO 2000-2019
Embase (04-02-19): 676 records returned
(‘pain’/exp OR ‘pain’ OR ‘pain management’/exp OR ‘pain management’ OR ‘pain measurement’/exp OR ‘pain measurement’)
AND (‘low birth weight’:ab,ti OR ‘infan∗’:ab,ti OR ‘newborn∗’:ab,ti OR ‘new born∗’:ab,ti OR ‘new-born’:ab,ti OR perinat∗:ab,ti OR neonat∗:ab,ti OR ‘baby’:ab,ti OR ‘babies’:ab,ti)
AND (educat∗:ab,ti OR teach∗:ab,ti OR learn∗:ab,ti OR ‘ehealth’:ab,ti OR ‘e-health’:ab,ti OR ‘elearn∗’:ab,ti OR ‘e-learn∗’:ab,ti)
AND (‘parent∗’ OR mother∗:ab,ti OR father∗:ab,ti)
AND [1-1-2000]/sd NOT [2-4-2019]/sd
Scopus (04-02-19): 17 records returned
INDEXTERMS (pain) OR INDEXTERMS (“pain management”) OR INDEXTERMS (“pain measurement”)
AND TITLE-ABS (‘low AND birth AND weight’ OR infan∗ OR newborn∗ OR new-born∗ OR “new born∗” OR perinat∗ OR neonat∗ OR baby OR babies)
AND TITLE-ABS (educat∗ OR teach∗ OR learn∗ OR health OR e-health OR elearn∗ OR e-learn∗)
AND TITLE-ABS (parent∗ OR mother∗ OR father∗)
NOTE: LIMITED TO 2000-2019
Web of Science (04-02-19): 314 records returned
TOPIC: (pain OR “pain management” OR “pain measurement”)
AND TOPIC: ((‘low AND birth AND weight’ OR infan∗ OR newborn∗ OR new-born∗ OR “new born∗” OR perinat∗ OR neonat∗ OR baby OR babies))
AND TOPIC: ((educat∗ OR teach∗ OR learn∗ OR ehealth OR e-health OR elearn∗ OR e-learn∗))
AND TOPIC: ((parent∗ OR mother∗ OR father∗))
SciELO Citation Index (04-02-19): 23 records returned
TOPIC: (pain OR “pain management” OR “pain measurement”)
AND TOPIC: ((‘low AND birth AND weight’ OR infan∗ OR newborn∗ OR new-born∗ OR “new born∗” OR perinat∗ OR neonat∗ OR baby OR babies))
AND TOPIC: ((educat∗ OR teach∗ OR learn∗ OR ehealth OR e-health OR elearn∗ OR e-learn∗))
AND TOPIC: ((parent∗ OR mother∗ OR father∗))
ProQuest Dissertations and Theses Global (04-02-19): 97 records returned
su(pain OR “pain management” OR “pain measurement”)
AND ab(‘low AND birth AND weight’ OR infan∗ OR newborn∗ OR new-born∗ OR “new born∗” OR perinat∗ OR neonat∗ OR baby OR babies) OR ti(‘low AND birth AND weight’ OR infan∗ OR newborn∗ OR new-born∗ OR “new born∗” OR perinat∗ OR neonat∗ OR baby OR babies)
AND ab(educat∗ OR teach∗ OR learn∗ OR ehealth OR e-health OR elearn∗ OR e-learn∗) OR ti(educat∗ OR teach∗ OR learn∗ OR ehealth OR e-health OR elearn∗ OR e-learn∗)
AND ab(parent∗ OR mother∗ OR father∗) OR ti(parent∗ OR mother∗ OR father∗)
Additional limits - Date: From January 01 2000 to December 31 2019
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