Integrative Care Therapies and Physiological and Pain-related Outcomes in Hospitalized Infants

Elizabeth E. Hathaway, BA, BS, Christina M. Luberto, MA, Lois H. Bogenschutz, RN, Sue Geiss, RN, Rachel S. Wasson, BA, and Sian Cotton, PhD

Elizabeth E. Hathaway, Department of Family and Community Medicine, Division of Integrative Medicine, University of Cincinnati College of Medicine, Ohio, United States (Ms Hathaway)

Contributor Information.

Corresponding author.

Correspondence Sian Cotton, PhD [email protected]

Abstract

摘要

SINOPSIS

BACKGROUND

Pain management is a common challenge in the neonatal intensive care unit (NICU), with infants in the NICU undergoing an average of 12 to 14 painful procedures each day.^1,2 As repeated painful procedures during infancy have been associated with long-term hyper-algesia and negative effects on cognition, learning, and motor functioning,^3,4 a research-driven affirmation of basic, compassionate motives for seeking effective pain management strategies is warranted. Depending on the type of procedure being performed, both nonpharmaco-logical and/or pharmacological pain management options may be appropriate.

Given the importance of managing neonatal pain in a comprehensive manner, studies have explored the use of non-pharmacological integrative health therapies such as massage therapy for neonatal pain.^5–7 Integrative health and medicine is a large and growing medical trend, reflecting the evidence-based integration of complementary treatments such as natural products (eg, fish oil, Co-Q10) and mind and body practices (eg, yoga, relaxation techniques) with conventional therapies.⁸ Evidence for biofield therapies is more limited, with studies reporting mixed findings and insufficient evidence for their recommendation.^9–11 An integrative approach to care has been shown to improve a wide range of health problems for both children and adults,⁸ and a growing number of studies support the use of integrative care therapies for managing neonatal pain,¹² stress,^13,14 and other issues such as weight, sleep, and immune function.^15–17

Previous studies of integrative care therapies for pain-related outcomes in neonates have focused on massage therapy, with most of the studies being randomized controlled trials (RCTs). Studies have reported a range of benefits including shorter hospital stays,¹⁸ less observed stress,¹⁴ greater weight gain,^15,17,19 neurological maturation,²⁰ and relaxation-related physiological changes such as lower cortisol levels,²¹ though therapy duration and techniques varied. Studies incorporating vital signs are limited, but one small observational study found lower pulse and respiratory rate and higher oxygen saturation for infants receiving the M technique, a relaxation method involving comforting touch.²² Still other studies have reported inconsistent results regarding clinical outcomes and/or physiological functioning.^6,23,24

The evidence supporting integrative therapies in infants has been used to formulate treatment recommendations for managing pain in neonates. For example, massage therapy and related techniques have been recommended as first-line or standard pain management techniques for neonates and preterm infants in several review articles,^25–27 with a review for nurses even providing specific guidance on kinesthetic movements and techniques.²⁸ In actual clinical practice, however, such pain management techniques are often underutilized^1,2; some NICUs have actually implemented restrictive “minimal touch” policies in order to minimize the potential for unpleasant or overstimulating sensations.²⁹ In a study of 90 California NICU nurses, fewer than half surveyed felt that newborn pain was well managed within their NICU.³⁰ Thus, despite clinical recommendations for the use of integrative care therapies for pain management in neonates, there remains a lack of integration of these therapies into clinical practice.^1,2,26

Translation of research findings into clinical practice in the NICU setting is limited by similar factors observed in other areas of health research, including the limited external validity of RCTs, lack of communication and collaboration between researchers and clinicians, and practical and financial considerations.³¹ In order to aid these translation efforts, the National Institutes of Health (NIH) has implemented the NIH Roadmap, a federal initiative aimed at enhancing the application of evidence-based treatments into real-world clinical settings.³² One strategy that the NIH Roadmap supports is the use of practice-based research, which involves systematically examining the effects of clinical interventions in natural clinical settings, helping to bridge from efficacy in controlled trials to effectiveness in actual clinical practice.³¹ Despite the various controlled trials of massage and other integrative care therapies in neonates, few studies have examined these therapies in a real-world clinical setting, limiting our understanding of the impact of these therapies and potentially impeding their clinical utilization.

Thus, the purpose of the current study was to examine the relationship between the use of integrative care therapies and pain-related outcomes among infants in a level III NICU using a practice-based study design. Specifically, we used a retrospective review of data collected during real-time clinical encounters to investigate the relationship between the delivery of integrative therapies, in particular massage therapy and healing touch, and both objective (ie, neonatal heart rate and oxygen saturation) and subjective (ie, clinician-reported neonatal pain and presentation) pain-related outcomes. We hypothesized that these integrative care therapies would be associated with reduced pain, improved presentation, decreased heart rate, and increased oxygen saturation among infants in the NICU.

METHODS

RESULTS

DISCUSSION

While results from RCTs support the safety and efficacy of integrative therapies, particularly massage therapy, in neonates, the impact of these therapies in real-world clinical settings is not well understood. The current study utilized a retrospective database review of practice-based data to examine the association between delivery of select integrative care therapies and pain-related outcomes in infants. As hypothesized, we found significant improvements in observed pain, presentation, and vital signs (ie, a slower heart rate and greater oxygen saturation) for infants in the NICU after receiving select integrative care therapies, namely massage and/or healing touch. Results from this study build on the results of previous studies supporting the efficacy of massage therapy and comforting touch in controlled trials and extend these data to provide preliminary support for the effectiveness of massage therapy and healing touch in real-world clinical settings. In keeping with the initiatives outlined in the NIH Roadmap,³¹ the current findings in combination with previous literature advance the field with evidence-based support for the integration of these therapies into the NICU.

Of interest is the directional agreement between therapist reports and objective measures of neonatal pain. We found that both subjective (ie, therapist-reported pain and presentation) and objective outcome measures (ie, heart rate and oxygen saturation) demonstrated statistically significant shifts toward a less stressed state. Given that infants are unable to verbally report their pain or distress levels, it is an important finding that therapist reports of infants’ pain are reliable and consistent with objective measures of stress. The congruence between these findings also allows for a more holistic assessment of neonatal pain, as it reflects improvements across both behavioral and physiological domains. The closest correlations in outcome measures were between the subjective metrics of pain and presentation, likely because these were both based on assessment of the infant’s observable state. However, statistically significant correlations were also observed between subjective and objective ratings, particularly pre-intervention.

Despite clinician awareness of the importance of pain management in the NICU, consistent application of pain management techniques remains a challenge in real-world practice. Restraint in analgesia use may stem from a conservative risk-benefit assessment of pharmacological pain treatments for the vulnerable NICU population. For example, when pain medication is administered, it may not always provide adequate pain relief and may carry the risk of adverse side effects, complications, tolerance, and withdrawal.^4,25 However, even nonpharmacological methods of pain management are underutilized^1,2,26; one recent NICU study of oral sucrose for pain management during heel lances found that a clinician education intervention increased the use of this therapy by over 80%, with an accompanying statistically significant reduction in assessed infant pain.³⁹

As with any study, there are limitations worth noting. All patients came from the same level III NICU in a Midwestern academic medical center, which limits generalizability of the results to other populations (eg, NICUs of different levels that treat different types of patients or pediatric wards). Second, there may be potential bias from therapist-reported pain and presentation outcomes. Assessment of outcome measures by a researcher other than the therapist would be preferable, though would require thoughtful planning and implementation in real-world settings where it would be unexpected for individuals not involved in the patient’s care to be recording their vital signs. The physiological measures also vary over short time spans, creating the possibility for bias in these measures if values were selected at more preferable points. Thus the limitation of bias in the subjective measures is only partially mitigated by the supporting physiological data. Finally, given that this was a real-world practice-based study, we are unable to control for variables such as research-driven inclusion and exclusion criteria, and a time- and attention-matched control group. This limitation reflects the inherent difficulty in finding a balance between internal and external validity in practice-based research studies.⁴⁰ Future studies should explore measuring the same outcomes in samples of patients who did not receive the therapies. It is important to remember, however, that many of these limitations are inherent and intentional aspects of practice-based research that serve to answer questions of effectiveness rather than efficacy and thus can also be viewed as valuable characteristics of the study design.

Future studies could address a variety of questions. While this study investigated initial effects after a single therapeutic interaction, effects over time and multiple therapist visits could be considered in future efforts. Assessment of broader health outcomes, such as level of functioning, over a longer duration and with clear tracking of adverse events would also bring future studies into closer alignment with formal criteria for effectiveness studies.⁴⁰ A study with a randomized design would be more appropriate for determining whether specific treatments differentially influence outcomes and providing guidance on the optimal integrative care therapies for use in a NICU setting. Investigating longer-term outcomes and the downstream impact on the potential cost savings of these services would help build support for more robust integrative care service delivery systems from administrative and insurance stakeholders. Finally, more complete patient data for gestational age in future studies would enable separate analysis of outcomes in preterm and full-term infants. While the current study provides preliminary support for the evidence-based incorporation of massage therapy and healing touch into the NICU setting as part of an overall pain management strategy, future research is needed to establish effectiveness and determine clinical best practices.

Notes

Disclosures The authors completed the ICMJE Form for Potential Conflicts and had no conflicts to disclose.

Funding This work was supported by the Division of Child Life and Integrative Care, Cincinnati Children’s Hospital Medical Center and the University of Cincinnati Center for Integrative Health and Wellness, Ohio.

Contributor Information

Elizabeth E. Hathaway, Department of Family and Community Medicine, Division of Integrative Medicine, University of Cincinnati College of Medicine, Ohio, United States (Ms Hathaway)

Christina M. Luberto, Department of Family and Community Medicine, Division of Integrative Medicine, University of Cincinnati College of Medicine, Ohio, United States (Ms Luberto) Department of Psychology, College of Arts and Sciences, University of Cincinnati, United States (Ms Luberto)

Lois H. Bogenschutz, Division of Child Life and Integrative Care, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, United States (Ms Bogenschutz)

Sue Geiss, Division of Child Life and Integrative Care, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, United States (Ms Geiss)

Rachel S. Wasson, Department of Family and Community Medicine, Division of Integrative Medicine, University of Cincinnati College of Medicine, Ohio, United States (Ms Wasson)

Sian Cotton, Division of Child Life and Integrative Care, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, United States (Dr Cotton)

REFERENCES