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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174404
• Other study ID #: 2019/00582
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2019
• Source: National University, Singapore
• Contact: Hong-Gu HE, PhD
• Phone: +6565167448
• Email: nurhhg[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Circumlocution
• Parents
• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
HE Hong-Gu	Buddy Healthcare Ltd OY, National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

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* Note: There are 126 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parents' preoperative anxiety and information requirement	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.	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.
Primary	Parents' perioperative knowledge	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.	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,
Primary	Parents' self-efficacy in child care	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.	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,
Primary	Parents' satisfaction with Perioperative Care	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.	Parents' satisfaction with Perioperative Care will be assessed at post-intervention around 2 weeks after surgery.
Primary	Children's preoperative anxiety: Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF)	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).	Children's preoperative anxiety will be assessed on the day right before the operation.
Primary	Children's postoperative pain: The Faces Pain Scale	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.	Children's postoperative pain will be measured at 24 hours post-surgery.
Primary	Health services use	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.	Health services use will be assessed around 2 weeks after surgery.
Primary	Process evaluation	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.	Process evaluation will be conducted around 2 weeks after surgery.

External Links

•   Buddy Healthcare joining the ICory project. Buddy Healthcare
•   Faces pain scale - revised home
•   Neonatal and child male circumcision: A global review
•   Play is the way to healthier life.
•   Research Electronic Data Capture
•   Research Randomizer
•   Singapore census of population 2010, statistical release 1: Demographic characteristics, education, language and religion.
•   Smart nation: The way forward [PDF file]
•   Smartphones in Singapore: A whitepaper release
•   State-Trait Anxiety Inventory (STAI): Mind Garden
•   Statistics on telecom services for 2017 (Jan-Jun)