Clinical trial NCT04174404: Intelligent Customer-driven Solution for Pediatric Surgery Care for Parents and Their Children Undergoing Circumcision
Official title: Developing and Testing the Effectiveness of Intelligent Customer-driven Solution for Pediatric Surgery Care on the Improvement of Outcomes of Parents and Their Children Undergoing Circumcision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circumlocution
Children
Surgery
Parents
Keywords: Pediatric Surgery Care
Circumcision
Children
Parent
perioperative care
randomised controlled trial
Self-efficacy
Preoperative anxiety
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
name: Buddy Healthcare Ltd OY
First posted: 2019-11-22
Enrollment: 160
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to (1) develop an intelligent customer-driven solution for pediatric surgery care for parents of children undergoing circumcision and their children; (2) examine the effectiveness of the intervention 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); and (3) explore users' (parents, children, health care professionals) perceptions of the intervention and suggestions for improvement.

Detailed 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.

Eligibility criteria: Children

Inclusion Criteria:

* age between 7-12 years old;
* is scheduled for an elective circumcision surgery;
* Is able to speak, and read in English;
* is accompanied by their parents (either mother or father or both) during the perioperative period; and
* has access to smart phone/tablet (own or rent from the project).

Exclusion Criteria:

* cognitive and learning disabilities identified from the medical record;
* a chronic illness and/or pain that required special medical care;
* anxiety disorder and other mood disorder as identified from their medical records;
* Hearing or visual impairments;
* depth perception deficits; and/or
* in the bereavement period in the past 6 months.

Parents

Inclusion Criteria:

* father or mother as main caregiver of the child who meet the aforementioned selection criteria;
* are 21 years and above;
* Able to communicate verbally and be literate in English; and
* have access to smart phone/tablets (own or rent from the project).

Exclusion Criteria:

* have visual/hearing impairment;
* have any cognitive impairment/mental disorder including anxiety disorder;
* have end stage of diseases; and/or
* in the bereavement period in the past 6 months.

Primary outcomes:
measure: Parents' preoperative anxiety and information requirement
timeFrame: Parents' preoperative anxiety and information requirement will be assessed at baseline (around 2 weeks before surgery) and will assess change between baseline and on the surgery day before the operation.
measure: Parents' perioperative knowledge
timeFrame: Parents' perioperative knowledge will be assessed at baseline (around 2 weeks before surgery) and will assess change between baseline and post-intervention at 2 weeks after surgery,
measure: Parents' self-efficacy in child care
timeFrame: Parents' self-efficacy will be assessed at baseline (around 2 weeks before surgery) and will assess change between baseline and post-intervention at 2 weeks after surgery,
measure: Parents' satisfaction with Perioperative Care
timeFrame: Parents' satisfaction with Perioperative Care will be assessed at post-intervention around 2 weeks after surgery.
measure: Children's preoperative anxiety: Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF)
timeFrame: Children's preoperative anxiety will be assessed on the day right before the operation.
measure: Children's postoperative pain: The Faces Pain Scale
timeFrame: Children's postoperative pain will be measured at 24 hours post-surgery.
measure: Health services use
timeFrame: Health services use will be assessed around 2 weeks after surgery.
measure: Process evaluation
timeFrame: Process evaluation will be conducted around 2 weeks after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: National University of Singapore
name: Hong-Gu HE, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Hospital, Singapore
name: Vidyadhar P Mali, PhD
role: PRINCIPAL_INVESTIGATOR
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