A randomized controlled trial of the effectiveness of an educational intervention on outcomes of parents and their children undergoing inpatient elective surgery: study protocol

Aim. To report a study protocol that tests the effectiveness of an educational intervention on outcomes of parents and their children who undergo inpatient elective surgery. Background. Inadequate children's postoperative pain management remains a global problem. Parents are required to be involved in their child's pain assessment and management, yet they often lack relevant knowledge and skills. Education is an effective strategy for enhancing a person's knowledge, attitudes and behaviour. However, few studies have examined its effectiveness in parents and their children undergoing inpatient elective surgery. Design. Randomized controlled trial and embedded qualitative process evaluation. Methods. One hundred and sixty-two pairs of participants (each comprised of one parent and his/her child undergoing inpatient elective surgery) will be recruited (protocol approved in January 2013). Participants will be randomized to either a Control group (routine care), an Intervention group 1 (routine care and an educational intervention with face-to-face teaching), or an Intervention group 2 (routine care and an educational intervention without face-to-face teaching). Outcome measures will include parents' knowledge, attitude and behaviour related to postoperative pain management; their child's postoperative pain; and parents' satisfaction with their child's pain management at baseline and around 6, 12 and 24 hours after the operation. Discussion. A standardized educational intervention protocol and detailed study procedure have been developed in this study to improve parents' knowledge, attitude and behaviour related to postoperative pain management and reduce their child's postoperative pain.