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

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT04174404

Acronym / sponsor ID

2019/00582

Conditions

Circumlocution, Children, Surgery, Parents

Keywords

Pediatric Surgery Care, Circumcision, Children, Parent, perioperative care, randomised controlled trial, Self-efficacy, Preoperative anxiety

Study type

Interventional

Recruitment status

Unknown status

Enrolment

160 participants (estimated)

Lead sponsor

HE Hong-GuUniversity, hospital or other

Collaborators

National University Hospital, Singapore, Buddy Healthcare Ltd OY

Study start

1 Nov 2019 (actual)

Primary completion

31 Oct 2020 (estimated)

Study completion

31 Oct 2020 (estimated)

First posted

22 Nov 2019 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Health services research

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (outcomes assessor)

Number of arms

2

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.

Who may qualify

Ages

7 to 12 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Parents' preoperative anxiety and information requirement

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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)

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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.

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
• Background: PubMed 22435267Ahmed MI, Farrell MA, Parrish K, Karla A. Preoperative anxiety in children risk factors and non-pharmacological management. Middle East J Anaesthesiol. 2011 Jun;21(2):153-64.
• BackgroundAmerican Psychiatric Association, & American Psychiatric Association. DSM-5 Task Force. (2013). Diagnostic and statistical manual of mental disorders: DSM-5 (5th ed.). Washington, DC: American Psychiatric Publishing.
• Background: PubMed 8022624Arntz A, Dreessen L, De Jong P. The influence of anxiety on pain: attentional and attributional mediators. Pain. 1994 Mar;56(3):307-314. doi: 10.1016/0304-3959(94)90169-4.
• BackgroundBandura, A. (1997). Self-efficacy: The Exercise of Control. New York: Freeman.
• Background: PubMed 30449445Bartik K, Toruner EK. Effectiveness of a Preoperative Preparation Program on Children's Emotional States and Parental Anxiety. J Perianesth Nurs. 2018 Dec;33(6):972-980. doi: 10.1016/j.jopan.2017.09.008. Epub 2017 Nov 20.
• BackgroundBegum, S., Pikkarainen, M., Mali, V.P., Loh, D., Wang, W., & He, H.G.* (2019). Experiences and Needs of Parents following their Child's Paediatric Day Surgery: A Descriptive Qualitative Study. Journal of Pediatric Nursing. (Under preparation)
• Background: PubMed 15367063Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
• Background: PubMed 22309487Bhansali R, Armstrong J. Smartphone applications for pediatric anesthesia. Paediatr Anaesth. 2012 Apr;22(4):400-4. doi: 10.1111/j.1460-9592.2012.03805.x. Epub 2012 Feb 6.
• BackgroundBjörkman, B., Golsäter, M., & Enskär, K. (2014). Children's anxiety, pain, and distress related to the perception of care while undergoing an acute radiographic examination. Journal of Radiology Nursing, 33(2), 69-78. doi:10.1016/j.jradnu.2013.12.003
• Background: PubMed 22926180American Academy of Pediatrics Task Force on Circumcision. Circumcision policy statement. Pediatrics. 2012 Sep;130(3):585-6. doi: 10.1542/peds.2012-1989. Epub 2012 Aug 27.
• Background: PubMed 12374706Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth. 2002 Oct;49(8):792-8. doi: 10.1007/BF03017410.
• BackgroundBowen, L., & Thomas, M. (2016). Paediatric day case surgery. Anaesthesia and Intensive Care Medicine, 17(6), 274-279. doi:10.1016/j.mpaic.2016.03.008
• Statistics on telecom services for 2017 (Jan-Jun)Link provided by the sponsor.
• Faces pain scale - revised homeLink provided by the sponsor.
• Buddy Healthcare joining the ICory project. Buddy HealthcareLink provided by the sponsor.
• Research Electronic Data CaptureLink provided by the sponsor.
• Research RandomizerLink provided by the sponsor.
• State-Trait Anxiety Inventory (STAI): Mind GardenLink provided by the sponsor.
• Individual participant dataSharing planned: No. Due to the PDPA in Singapore, PI doesn't plan to share data to public.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.