Home-Initiated Programme to Prepare for Operation (HIPPO) Study

Study Overview
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Brief Summary
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A hospital admission and surgical operation commonly triggers great fear and anxiety to young children. This is caused by either lack of knowledge or misconception. Although parent and families are often given the task to prepare the child for the oncoming surgery, they often lack information and skill to accomplish this task. Although numerous measures such as pre-operative play room, parental companion during induction, distraction therapy have been employed in our institution, this remains to be a challenge for care of young surgical patients. Our study proposes to use a prepare-for-operation (PFO) bundle to assist our paediatric patients and their families to prepare for surgery. The PFO bundle consists of an informative cartoon video illustrating sequence of events occurring in admission, anesthesia and surgery. The video is also accompanied by activity sheets to encourage patient and family to engage, participate and learn about all these events. They will be instructed to use this PFO bundle before admission. We believe that through this off-site and cost-effective intervention, the fear of children undergoing surgery will be significantly alleviated. The family will also have better satisfaction on hospitalization experience. If proven feasible and effective, this will be a simple intervention tool that can be made accessible to all KKH pediatric patients.

Detailed Description
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Research Plan: A prospective assessor-blinded randomized controlled which will recruit 130 pediatric surgical patients aged 4-10 years, undergoing elective operation in KKH. Eligible patients will be identified when an operation date has been booked. They will be approached by a research coordinator (RC) who will counsel about the study details, and recruited after consent. Randomisaiton will be performed. The subjects will be randomised into group A and group B. Group A will undergo standard workflow for elective surgical admissions. Group B, in addition to standard workflow, will also receive the PFO bundle which consists of: A cartoon video of about 6 minutes duration illustrating the events occuring during admission, anaesthesia and surgery. Video will be given out in DVD and/or with a weblink and a QR code for scanning. The weblink is password protected and is only given to participant and their parents randomised into the video group. Instruction will be given to participants and their parents to watch the video 3 days prior to admission Sets of activity sheets which have been tailored for different age groups. Families would be encouraged to complete activity sheets together.

Official Title
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Prepare for Operation Bundle for Young Children Undergoing Elective Surgery: Emotional Manifestation and Anxiety

Conditions
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Anxiety, Fear of Pain, Child Behavior

Intervention / Treatment
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* Other: Video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 4-10 years, male or female No prior surgical experience Able to communicate clearly, navigate simple technical software, be awake and alert Normal development Able to read and communicate in English Exclusion Criteria: Abnormal development Has had prior surgical experience Is participating in another study

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patient will undergo standard workflow for elective surgical admissions. | |
| Experimental: Video<br>In addition to standard workflow, will also receive the intervention bundle which consists of a cartoon video and sets of activity sheets | Other: Video<br>* In addition to standard workflow, participants will also receive the PFO bundle which consists of: 1) A cartoon video of about 6 minutes duration illustrating the events occurring during admission, anaesthesia and surgery and 2) Sets of activity sheets which have been tailored for different age groups. Families would be encouraged to complete activity sheets together.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Emotional Manifestation Scale | the behaviour and emotional status of the child will be assessed by a blinded assessor. The score ranges from 5 to 25 where a score of 25 indicates 'uncooperative behaviour' and 5 indicates 'cooperative behaviour'. | 1 day | 
| Anxiety score | Spielberger State-Trait Anxiety Inventory Score for Children (STAIC) which is a validated anxiety score in children, or the Spielberger State-Trait Anxiety Inventory (STAI) Score which is a validated anxiety score in adolescents and adults. This score allows adjustment for the different scores that may be produced for a given situation in individuals who may vary in baseline anxiety levels. | 1 day | 
| Feeling thermometer | A 5-point likert scale for the child to rate their feeling, where a score of 1 indicates 'very scared' and 5 indicates 'very happy'. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) | Presented on a 100-mm line with two extreme, not anxious left and very anxious right, on which the anesthesiologist blinded to child treatment group, marks the point that represents their perception of the child's anxiety. | 1 day | 
| Induction compliance checklist (ICC) | An observational scale consisting of 10 behaviors scored rated by anesthesiologist blinded to child treatment group, ranging from 0-10 where a score of 10 indicates 'very difficult child induction' and 0 indicates 'perfect/cooperative child induction'. | 1 day | 
| Admission feedback questionnaires | A modified version of the patient satisfaction survey currently used by KK Hospital to assess patient satisfaction with outpatient services | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, pre-operation