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

HE Hong-Gu

Status: Unknown

Conditions: Surgery; Parents; Circumlocution; Children

Treatments: Other: Routine care; Other: ICory-Circumcision

Study type: Interventional

Funder types: Other

Identifiers

NCT04174404

2019/00582

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Intervention group

Experimental group

Description:

The participants in the intervention group will receive the routine care plus the ICory-Circumcision which is specially developed for this study based on preliminary studies, other literature, and most importantly, the surgical pathway currently practiced in the study hospital. The ICory-Circumcision programme has two components: (1) the Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support and distraction to children.

Treatment:

Other: Routine care

Other: ICory-Circumcision

Control group

Active Comparator group

Description:

The participants in the control group will receive routine care provided by the hospital which consists of normal doctor consultant, preoperative preparation, and postoperative care.

Treatment:

Other: Routine care