Pain Management for Infants during Vaccination: Evaluation of Online Resources and Pilot Testing of Parent-Targeted Interventions Shokoufeh Modanloo, BScN, MScN A thesis submitted to Faculty of Health Sciences, School of Nursing in partial fulfillment of the requirements for the Doctorate in Philosophy degree in Nursing Faculty of Health Sciences School of Nursing University of Ottawa © Shokoufeh Modanloo, Ottawa, Canada, 2020 VACCINATION PAIN MANAGEMENT FOR INFANTS ii Abstract The overall aim of this thesis was to improve the use of recommended pain management strategies during infant vaccination by investigating the quality and use of evidence-based online parent resources. Study 1: A two-armed pilot randomized control trial (RCT) was conducted to evaluate the feasibility, acceptability and preliminary efficacy of two interventions, delivered online, aimed at improving the use of recommended pain management strategies during infant vaccination. Parents of infants < six months old were randomized to 1) Be Sweet to Babies videos and tip sheet; and 2) Be Sweet to Babies videos, tip sheet and Motivational Interviewing- informed Affirmative Statements and Questions (AS&Q). Results showed it was feasible to recruit parents via online means (201 eligible respondents recruited in a week, 170, 85% provided written consent, and 89, 59% completed all data collection. From these 89 participants, there was high acceptability of the study, 84 (94%) were satisfied with study processes, and 78 (88%) intended to recommend the strategies to others. For preliminary efficacy, almost all participants used at least one of the pain management strategies in the subsequent vaccination (Intervention 1 (49, 98%); Intervention 2 (38, 95%)). There were no significant differences in the use of pain management strategies between the two study groups. Study 2: To investigate the quality of online parent resources about vaccination pain management, an environmental scan of Google and Social Media networks (i.e. Facebook, YouTube, and Twitter) was conducted. The quality of resources was evaluated using the Center for Diseases Control and Prevention (CDC) Clear Communication Index. 65 resources (55 written, 10 videos), were included. The mean quality score was 60% ± 0.19. Only 5% of resources scored an acceptable quality of >90%. Only 30 (46%) resources included evidence- VACCINATION PAIN MANAGEMENT FOR INFANTS iii based content on pain management strategies during vaccination, which included breastfeeding (24, 37%), holding (27, 42%), and sweet solutions (22, 34%). Most publicly accessible online parent-targeted vaccination resources were of poor to moderate quality and did not contain pain management information during vaccination. The study was shown to be feasible and acceptable to those parents who completed the study. The Internet is an efficient way to recruit parents for trial participation and to disseminate knowledge. Keywords: childhood vaccination, pain management, parents, knowledge translation VACCINATION PAIN MANAGEMENT FOR INFANTS iv Acknowledgments I cannot express my gratitude enough for what this journey brought me to. This Ph.D. is not only an academic degree to me, but it is also the product of my personal growth, self- reflection, and finding the passion and purpose in my life. I am genuinely blessed to have the opportunity to study, live and work in Canada, where I can happily call it “home” now. Canada, you were good to me and I do my best not to take my privileges for granted and never forget how lucky I am. When I look back at my journey, it has had a lot of ups and downs. Because of those experiences I am now an advocate for what I have been through; my heart goes out to all people who are dealing with mental health problems in their life. I will do my best to be real, supportive and fight against the existing stigma. Further, I would like to express my respect to all women and children of vulnerable populations, I will never stop fighting for attaining their rights in health equity and social justice. However, this journey was not a solo mission by any means, I would like to thank my supervisor Dr. Denise Harrison for the excellent knowledge and expertise in the field of infant pain management. I could not complete this program without her great mentorship, ongoing support, and generous guidance throughout the journey. I truly admire her strong leadership skills that taught me how to be the voice of my research in the academic world. Thank you, Denise, for providing this learning opportunity and being incredibly patient with me. Most importantly, I am also thankful for my research committee members, Drs Stacey and Dunn, for their great advice, valuable time, and knowledge provided to me. Their excellent expertise in the field of knowledge translation and implementation science shed light on my path at different levels to complete this dissertation. VACCINATION PAIN MANAGEMENT FOR INFANTS v I would like to thank all the parents who participated in this dissertation. I also acknowledge the financial support I received from the University of Ottawa, International Doctoral Scholarship and International Admission Full Scholarship. The university support helped me gain experience as a teaching assistant in seven nursing courses at undergraduate and graduate levels during the last four years. I also would like to acknowledge the travel awards and grants I received from the University of Ottawa, the Pain in Child Health (PICH) trainee consortium, along with my supervisor’s support. Their generous supports helped me participate and present ten study abstracts in different national conferences and networking events across Canada. This opportunity helped me connect with many amazing researchers, mentors, and trainees in the field of pediatric pain research nationally and internationally. As a result, I have contributed to seven academic publications during the last four years in addition to my Ph.D. studies. Last but not the least, I would like to thank my beloved ones (Maman, Baba, and my beautiful sister Bahar), whom I could have not been here without their ongoing emotional support, they were always there for me and never stopped believing in me. Love you to the moon and back! Shokoufeh, 26.09.2019 VACCINATION PAIN MANAGEMENT FOR INFANTS vi Preface This dissertation is presented as a thesis with the two studies written as manuscripts formatted for the target journals. Both manuscripts are included as result chapters. Co-Authorship: Denise Harrison, RN, Ph.D. School of Nursing, University of Ottawa and Children’s Hospital of Eastern Ontario (CHEO) Research Institute. As the Ph.D. supervisor, Dr Harrison co-authored each manuscript of this dissertation. She provided guidance and support throughout this dissertation. Dawn Stacey, RN, Ph.D. School of Nursing, University of Ottawa, Ottawa Hospital Research Institute, Ontario, Canada. Sandra Dunn, RN, Ph.D. Children’s Hospital of Eastern Ontario (CHEO) Research Institute, and Better Outcomes Registry & Network (BORN), Ontario, Canada. As my dissertation committee members, Drs. Stacey and Dunn co-authored the manuscripts and provided support and guidance on the studies’ design, progress, and reporting the results, and contributed greatly to the development and completion of this dissertation. Juliana Choueiry, BScN, Children’s Hospital of Eastern Ontario (CHEO) Research Institute, Ottawa, Ontario, Canada. Juliana co-authored the second manuscript of this dissertation. She helped as a second screener in the quality appraisal of online resources and proofreading the final manuscript. VACCINATION PAIN MANAGEMENT FOR INFANTS vii List of Abbreviations AS&Q: Affirmation Statements and Questions CHEO: Children’s Hospital of Eastern Ontario CIHR: Canadian Institutes of Health Research CDC: Center for Diseases Control and Prevention CNICS: Childhood National Immunization Coverage Survey HELPinKIDS: Help Eliminate Pain in Kids HCP: Health Care Providers IASP: International Association for the Study of Pain ICN: International Council of Nursing IQR: Inter Quartile Range KT: Knowledge Translation KTA: Knowledge to Action MI: Motivational Interviewing RCT: Randomized Controlled Trial REDCap: Research Electronic Data Capture SKIP: Solutions for Kids in Pain WHO: World Health Organization VACCINATION PAIN MANAGEMENT FOR INFANTS viii Table of Contents Abstract ........................................................................................................................................... ii Acknowledgments.......................................................................................................................... iv Preface............................................................................................................................................ vi List of Abbreviations .................................................................................................................... vii Table of Contents ......................................................................................................................... viii List of Figures ............................................................................................................................... xv List of Tables ............................................................................................................................... xvi Chapter 1 – Introduction and Background ...................................................................................... 1 Introduction ................................................................................................................................