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Parents' perceptions of their infants' participation in randomized controlled trials

Cartwright, K., Mahoney, L., Ayers, S. & Rabe, H. (2011). Parents' perceptions of their infants' participation in randomized controlled trials. JOGNN - Journal of Obstetric, Gynecologic, and Neonatal Nursing, 40(5), pp. 555-565. doi: 10.1111/j.1552-6909.2011.01276.x

Abstract

Objective: To explore parents‟ perceptions of their infant‟s participation in a randomized control trial (RCT) and the implications of the RCT for their infant and them.

Design: A qualitative study using semi-structured interviews. Setting: Participants were identified from neonatal intensive care unit (NICU) clinical registers and from responses to an advertisement put on the website of UK special care baby charity, BLISS. Interviews were conducted with parents face-to-face in their homes or over the telephone.

Participants: Sixteen parents of 12 infants born prematurely or with complications at full term and who had participated in 1 of 3 RCTs while receiving intensive care in 1 of 7 NICUs. Methods: Interviews were audio-taped or digitally recorded, transcribed verbatim, and analyzed using systematic thematic analysis using WinMax qualitative software.

Results: Five main themes emerged from the data. The themes were (a) parents‟ immediate reactions to being approached about RCT enrollment, (b) interactions between parents and clinicians upon the approach of enrollment and during the RCT, (c) making the decision to enroll their infant, (d) implications of the RCT for parents, and (e) effects of the RCT on the infant.

Conclusions: Clinicians should be encouraged to approach parents about enrollment of their infants in clinical research given that parents reported mostly positive experiences of their infant‟s participation in a RCT. However, appropriate measures should be taken to ensure that the individual needs of parents are being met throughout the entire research process from enrollment to follow-up.

Publication Type: Article
Publisher Keywords: parents, perceptions, infants, participation, randomized controlled trials
Subjects: B Philosophy. Psychology. Religion > BF Psychology
Departments: School of Health & Psychological Sciences > Nursing
SWORD Depositor:
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