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

Sponsor
HE Hong-Gu (Other)
Overall Status
Unknown status
CT.gov ID
NCT04174404
Collaborator
National University Hospital, Singapore (Other), Buddy Healthcare Ltd OY (Other)
160
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ICory-Circumcision
  • Other: Routine care
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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
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
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Oct 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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.

Other: ICory-Circumcision
The ICory-Circumcision 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. The ICory-Circumcision programme is designed to be a self-guided and healthcare professional-led. Participants will have access to BuddyCare for parents and Triumf Health from time of recruitment till 2 weeks after surgery while the healthcare professional would receive face-to-face training on how to use the BuddyCare dashboard.

Other: Routine care
The routine care consists of normal consultations with the doctor, preoperative preparation, and post-operative care. During the first consultation, the child will be assessed for the need for circumcision and the doctor explains verbally to the parents about the procedure, risks, what to expect and prepare pre-operatively.
Active Comparator: Control group

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.

Other: Routine care
The routine care consists of normal consultations with the doctor, preoperative preparation, and post-operative care. During the first consultation, the child will be assessed for the need for circumcision and the doctor explains verbally to the parents about the procedure, risks, what to expect and prepare pre-operatively.

Outcome Measures

Primary Outcome Measures

  1. Parents' preoperative anxiety and information requirement [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.]

    The Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Moerman, van Dam, Muller & Oosting, 1996) will be used to measure parents' preoperative anxiety and information requirement. The APAIS is a six-item questionnaire consisting of 4 questions about the fear of anesthesia and procedure while 2 questions are about the need for information. The questionnaire is scored based on a likert scale of 1 to 5. A score of 1 would mean 'not at all' while 5 would mean 'extremely'. The total score for the anxiety scale can range from 4 to 20 while the need for information scale ranges from 2 to 10. The higher the scores, the higher the anxiety and the information required by the respondents.

  2. Parents' perioperative knowledge [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,]

    The self-developed Parents' Perioperative Knowledge Questionnaire (PPKQ) will be used for assessing parents' perioperative knowledge with regards to the circumcision. It was developed by the study team. A content validity will be done by an expert panel consisting of 5-10 experts (Gilbert & Prion, 2016). The PPKQ contains 10 multiple choices questions. The higher number of questions answered correctly would indicate a higher understanding of the comprehension of the perioperative process thus better knowledge.

  3. Parents' self-efficacy in child care [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,]

    A self-developed Parents' Self-Efficacy in Children's Perioperative Care (PSeCPC) questionnaire will be used to measure parents' self-efficacy in childcare throughout the perioperative process. There are 8 items for this scale and each item is rated on four responses: 1= not confident at alll, 2= a little confident, 3= moderately confident, 4=quite confident and 5= extremely confident. The total score is 8-40. Higher score means better self-efficacy.

  4. Parents' satisfaction with Perioperative Care [Parents' satisfaction with Perioperative Care will be assessed at post-intervention around 2 weeks after surgery.]

    A 6-point Ordinal Descriptive Scale - Satisfaction with Perioperative Care (ODS-SPC) will be used to assess parents' satisfaction with ICory-Circumcision and routine care. The scale only consists of one item and it is scored on a 6-point ordinal scale of 1 for "Very dissatisfied" to a score of 6 for "Very satisfied". The total score can range from 1 to 6. A higher score would indicate higher satisfaction with the perioperative care.

  5. Children's preoperative anxiety: Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF) [Children's preoperative anxiety will be assessed on the day right before the operation.]

    Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF) (Jenkins, Fortier, Kaplan, Mayes & Kain, 2014) will be used to measure the preoperative anxiety levels of the children right before the operation. It is a 4-item scale (activity, vocalization, emotional expressivity, state of apparent arousal) and it is filled in via observation. The total score ranges from 23 to 100. Higher scores mean higher levels of anxiety. A score of 31 and above would indicate high-anxiety (Kain et al., 1997; Rema, Cavaleiro, Pina & Machado, 2016).

  6. Children's postoperative pain: The Faces Pain Scale [Children's postoperative pain will be measured at 24 hours post-surgery.]

    The Faces Pain Scale - Revised (FPS-R) (International Association for the Study of Pain [IASP], 2001) will be used to assess the postoperative pain of the children. The FPS-R shows six faces with different facial expressions and the child is given instructions to point to the face corresponding to the amount of pain he feels at that moment. The scores range from 0-10 with a higher score means greater pain.

  7. Health services use [Health services use will be assessed around 2 weeks after surgery.]

    Health services use will be assessed by Healthcare Services Utilisation Questionnaire (HSUQ) to capture post-discharge information on resource utilization for each participant, e.g. emergency room attendance, and unplanned medical consultation at GP/ private clinic. The minimal service use will be zero, but there is no maximal limited. The higher value of services use indicates worse outcome.

  8. Process evaluation [Process evaluation will be conducted around 2 weeks after surgery.]

    Process evaluation will be evaluated by semi-structured interviews. A semi-structured interview guide will be used to interview the parents and children in the intervention group (aiming 15-30) and healthcare professionals who used ICory-Circumcision. Parents and children will be asked about the contents, activities, and delivery methods, and usefulness of the application. Healthcare professionals will be asked about the strengths and weaknesses of the application and their opinion about the application from their perspective. This is a qualitative data and the data will be analyzed by thematic analysis. Thus, there is no score for this evaluation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National University of Singapore Singapore Singapore 117597

Sponsors and Collaborators

  • HE Hong-Gu
  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
HE Hong-Gu, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier:
NCT04174404
Other Study ID Numbers:
  • 2019/00582
First Posted:
Nov 22, 2019
Last Update Posted:
Nov 25, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by HE Hong-Gu, Associate Professor, National University, Singapore
Pediatric Surgery Care
Circumcision
Children
Parent
perioperative care
randomised controlled trial
Self-efficacy
Preoperative anxiety

Study Results

No Results Posted as of Nov 25, 2019