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Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial
Routinely children are exposed to various procedures as a part of clinical care and/or research participation. Public health strategies to contain current COVID‐19 pandemic demanded massive nasopharyngeal swab testing but limited data exist to confirm the extent of the pain and distress that result...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8975197/ https://www.ncbi.nlm.nih.gov/pubmed/35548556 http://dx.doi.org/10.1002/pne2.12068 |
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author | Kawade, Anand Dayma, Girish Apte, Aditi Roy, Sudipto Gondhali, Arun Juvekar, Sanjay Bavdekar, Ashish |
author_facet | Kawade, Anand Dayma, Girish Apte, Aditi Roy, Sudipto Gondhali, Arun Juvekar, Sanjay Bavdekar, Ashish |
author_sort | Kawade, Anand |
collection | PubMed |
description | Routinely children are exposed to various procedures as a part of clinical care and/or research participation. Public health strategies to contain current COVID‐19 pandemic demanded massive nasopharyngeal swab testing but limited data exist to confirm the extent of the pain and distress that result from this procedure. These data could help clinicians to formulate mitigation strategies, influence public health directives, and inform review boards/ethics committees to decide on risk‐benefit ratio of the procedure. Hence, an observational study to assess perceived distress was nested in a phase IV alternate and reduced dose schedule trial of the pneumococcal conjugate vaccine (PCV) in which nasopharyngeal swab (NPS) was used to collect nasopharyngeal secretions as part of the study procedure. Out of 805 infant participants enrolled in the main study, a total of 425 infants were enrolled and observed for procedural distress at 18 weeks and 10 months of age using the Face Leg Activity Cry and Consolability (FLACC) Scale. The FLACC score and duration of cry were recorded. The mean FLACC score changed substantially from preprocedural to procedure in both age groups (from 0.08 to 5.8 at 18 weeks and from 0.5 to 7.007 at 10 months. P = <.0001). The proportion of infants experiencing higher FLACC scores (7‐10) indicating severe distress increased significantly from 22% (n = 95) at 18 weeks to 61% (n = 248) at 10 months (P < .0001). The mean duration of cry was significantly increased from 23.03 seconds at 18 weeks to 52.6 seconds at 10 months (P = .00). Nasopharyngeal swab collection produced substantial distress which increased with age. Adequate training of sample collectors and supporting parent engagement during procedure could help in reducing the distress. |
format | Online Article Text |
id | pubmed-8975197 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-89751972022-05-10 Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial Kawade, Anand Dayma, Girish Apte, Aditi Roy, Sudipto Gondhali, Arun Juvekar, Sanjay Bavdekar, Ashish Paediatr Neonatal Pain Original Articles Routinely children are exposed to various procedures as a part of clinical care and/or research participation. Public health strategies to contain current COVID‐19 pandemic demanded massive nasopharyngeal swab testing but limited data exist to confirm the extent of the pain and distress that result from this procedure. These data could help clinicians to formulate mitigation strategies, influence public health directives, and inform review boards/ethics committees to decide on risk‐benefit ratio of the procedure. Hence, an observational study to assess perceived distress was nested in a phase IV alternate and reduced dose schedule trial of the pneumococcal conjugate vaccine (PCV) in which nasopharyngeal swab (NPS) was used to collect nasopharyngeal secretions as part of the study procedure. Out of 805 infant participants enrolled in the main study, a total of 425 infants were enrolled and observed for procedural distress at 18 weeks and 10 months of age using the Face Leg Activity Cry and Consolability (FLACC) Scale. The FLACC score and duration of cry were recorded. The mean FLACC score changed substantially from preprocedural to procedure in both age groups (from 0.08 to 5.8 at 18 weeks and from 0.5 to 7.007 at 10 months. P = <.0001). The proportion of infants experiencing higher FLACC scores (7‐10) indicating severe distress increased significantly from 22% (n = 95) at 18 weeks to 61% (n = 248) at 10 months (P < .0001). The mean duration of cry was significantly increased from 23.03 seconds at 18 weeks to 52.6 seconds at 10 months (P = .00). Nasopharyngeal swab collection produced substantial distress which increased with age. Adequate training of sample collectors and supporting parent engagement during procedure could help in reducing the distress. John Wiley and Sons Inc. 2021-12-26 /pmc/articles/PMC8975197/ /pubmed/35548556 http://dx.doi.org/10.1002/pne2.12068 Text en © 2021 The Authors. Paediatric and Neonatal Pain published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Kawade, Anand Dayma, Girish Apte, Aditi Roy, Sudipto Gondhali, Arun Juvekar, Sanjay Bavdekar, Ashish Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial |
title | Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial |
title_full | Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial |
title_fullStr | Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial |
title_full_unstemmed | Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial |
title_short | Assessment of perceived distress due to nasopharyngeal swab collection in healthy Indian infants participating in a clinical trial |
title_sort | assessment of perceived distress due to nasopharyngeal swab collection in healthy indian infants participating in a clinical trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8975197/ https://www.ncbi.nlm.nih.gov/pubmed/35548556 http://dx.doi.org/10.1002/pne2.12068 |
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