title: Experiences of being a control group: lessons from a UK-based randomized controlled trial of group singing as a health promotion initiative for older people.
abstract: Existing randomized controlled trials within the health field suggest that the concept of randomization is not always well understood and that feelings of disappointment may occur when participants are not placed in their preferred arm. This may affect a study's rigour and ethical integrity if not addressed. We aimed to test whether these issues apply to a healthy volunteer sample within a health promotion trial of singing for older people. Written comments from control group participants at two points during the trial were analysed, together with individual semi-structured interviews with a small sample (n = 11) of this group. We found that motivation to participate in the trial was largely due to the appeal of singing and disappointment resulted from allocation to the control group. Understanding of randomization was generally good and feelings of disappointment lessened over time and with a post-research opportunity to sing. Findings suggest that measures should be put in place to minimize the potential negative impacts of randomized controlled trials in health promotion research.
authors: Sidney De Haan Research Centre for Arts and Health, Canterbury Christ Church University, University Centre Folkestone, Folkestone, Kent, UK ann.skingley@canterbury.ac.uk.
authors: Ann
authors: A
authors: Skingley
authors: Allied Health & Medicine, Anglia Ruskin University, Cambridge, UK.
authors: Hilary
authors: H
authors: Bungay
authors: Sidney De Haan Research Centre for Arts and Health, Canterbury Christ Church University, University Centre Folkestone, Folkestone, Kent, UK.
authors: Stephen
authors: S
authors: Clift
authors: School of Nursing, Midwifery and Social Work, Manchester University, Manchester, UK.
authors: June
authors: J
authors: Warden
mesh_terms: D000368:Aged; D035061:Control Groups; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009042:Motivation; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D063346:Singing
keywords: arts and health; control group; older people; randomized controlled trial