title: Anxiety and acceptability related to participation in stillbirth research.
abstract: BACKGROUND
  stillbirth research is often hampered by the need to 'protect' both bereaved families as well as healthy pregnant women from distress resulting from recruitment by research staff. No studies have investigated anxiety levels of recently bereaved or healthy pregnant women participating in stillbirth research. The aim of this study was to assess anxiety levels and acceptability of women participating in a stillbirth case-control study.
  
  
  METHODS
  a follow-up questionnaire was posted to all participants of the Sydney Stillbirth Study in 2012. The questionnaire assessed the anxiety level experienced by women as a result of their participation in the study. Questions related to the initial approach of the research staff; level of anxiety at time of consent and after the interview; and reasons for and satisfaction with participation. The Spielberger (STAI-6) anxiety scale and open-field responses were included.
  
  
  RESULTS
  35/103 case participants and 65/192 control participants returned the completed questionnaire. The majority participated for altruistic reasons. 20/35 (cases) and 58/65 (controls) stated they disagreed/strongly disagreed that participation in the study increased their anxiety. 1 in 5 cases reported that participation in the study increased their anxiety; however this did not affect their satisfaction. Timing of interview did not affect anxiety scale responses. (F=1.2; p=0.37) 30/35 (cases) and 63/65 (controls) stated they agreed/strongly agreed that they were satisfied participating in the study.
  
  
  CONCLUSIONS
  these findings suggest high levels of satisfaction amongst both case and control participants and no statistically significant increase in anxiety related to involvement in stillbirth research. 'Protecting' families may require further justification.
authors.affiliation: Department of Neonatal Medicine, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW 2050, Australia; Perinatal Research, Kolling Institute, University of Sydney, RNSH Campus, Reserve Rd, St Leonard's, NSW 2065, Australia. Electronic address: diana.bond@sydney.edu.au.
authors.forename: Diana
authors.initials: D
authors.lastname: Bond
authors.affiliation: Sydney School of Public Health, University of Sydney, NSW, Australia. Electronic address: camille.raynes-greenow@sydney.edu.au.
authors.forename: Camille
authors.initials: C
authors.lastname: Raynes-Greenow
authors.affiliation: Perinatal Research, Kolling Institute, University of Sydney, RNSH Campus, Reserve Rd, St Leonard's, NSW 2065, Australia; Sydney Medical School, University of Sydney, NSW, Australia. Electronic address: adrienne.gordon@sydney.edu.au.
authors.forename: Adrienne
authors.initials: A
authors.lastname: Gordon
mesh_terms: D000328:Adult; D001007:Anxiety; D016022:Case-Control Studies; D005260:Female; D005500:Follow-Up Studies; D006117:Grief; D006302:Health Services Research; D006801:Humans; D009035:Mothers / Q000523:psychology*; D018579:Patient Selection / Q000941:ethics; D011247:Pregnancy; D050497:Stillbirth / Q000523:psychology*; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Anxiety; Bereavement; Research participation; Satisfaction; Stillbirth