Intelligent Customer-driven Solution for Pediatric Surgery Care for Parents and Their Children Undergoing Circumcision

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Children
Circumlocution
Parents
Surgery

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study will be a two-group pretest and repeated posttest pilot randomised controlled trial followed by a qualitative process evaluation. A randomized controlled trial design was chosen as it has been the gold standard in testing effectiveness of a new intervention or treatment. A qualitative process evaluation is incorporated into this study design to explore the experiences of the participants' use of the applications. A total of 80 dyads of parents and their primary school-aged children (7-12 years old) will be randomly assigned into the intervention group which will receive the ICory-Circumcision plus routine care, whereby the parents will receive the BuddyCare application while the child will receive the Triumf game application, and the control group, who will just receive routine care provided by the hospital.Masking: Single (Outcomes Assessor)Masking Description: The investigators will firstly generate certain sets of random numbers from 1 to 6 by using Research Randomiser (Research Randomiser, 2019). Each number represents one combination of the allocations, e.g. 1 - [I I C C}, 2 - {I C I C}, 3 - {I C C I}, 4- {C I C I}, 5- {C I I C} and 6 - {C C I I} where I and C represent the allocation to the intervention and control group, respectively. Such randomly generated sequences will be used to allocate participants, who will be assigned in successive order according to the sequence. Opaque, sealed envelopes with cardboard inside indicating the randomly assigned group will be prepared by the PI. Through these processes, randomisation and allocation concealment will be ensured (Doig & Simpson, 2005; Schulz & Grimes, 2002). One research assistant will recruit participant, collect baseline data, conduct randomisation, and deliver the intervention, while another research assistant who is blind from group allocation will collect post-test data.Primary Purpose: Health Services Research

Participation Requirements

Age: Between 7 years and 12 years
Gender: Both males and females

Description

Objectives: The aims of this study are: (1) to develop an intelligent customer-driven solution for pediatric surgery care for parents of children undergoing circumcision (ICory- Circumcision) and their children; (2) to examine the effectiveness of the ICory- Circumcision on outcomes of parents (self-efficacy in child care, perioperative knowledge, and satisfaction in perioperative care, need for information and anxiety) and children (preoperative anxiety and postoperative pain), as well as no-show/ delayed show up for operation cases and health services use; and (3) to explore users' (parents, children, health care professionals) perceptions of the intervention and suggestions for improvement. Study design: This study will be a two-group pretest and repeated posttest pilot randomised controlled trial followed by qualitative process evaluation. A total of 80 dyads of parents and their primary school-aged children (7-12 years old) will be randomly assigned into the intervention group which will receive the ICory-Circumcision plus routine care, whereby the parents will receive the BuddyCare application while the child will receive the Triumf game application, and the control group, who will just receive routine care provided by the hospital. An interview guide will be developed and used to interview the parents and healthcare professionals who used ICory-Circumcision to explore their experiences and opinions on strengths, weaknesses and areas for improvement. The children who have used the Triumf game will also be interviewed to explore their experiences about the game application. Hypothesis: When compared to the control group, (1) parents in the intervention group who receive the ICory-Circumcision will report a significantly (a) higher level of self-efficacy in child care; perioperative knowledge and satisfaction (b) lower level of needs for information and preoperative anxiety. (2) The children in the intervention group will report a significantly lower level of preoperative anxiety and postoperative pain. (3) The intervention group will have fewer cases of no-show/ delayed show up for operation, and reduced health services use (e.g. reduced A & E department or GP attendance for non-medical reasons) within 2 weeks after the surgery.

Tracking Information

NCT #

NCT04174404

Collaborators

National University Hospital, Singapore
Buddy Healthcare Ltd OY

Investigators

Principal Investigator: Hong-Gu HE, PhD National University, Singapore Principal Investigator: Vidyadhar P Mali, PhD National University Hospital, Singapore