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

Sponsor
KK Women's and Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04271553
Collaborator
(none)
130
1
2
14.5
9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Video
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Masking Description:
prospective blinded (assessor) randomized controlled trial
Primary Purpose:
Other
Official Title:
"Prepare for Operation" Bundle for Young Children Undergoing Elective Surgery: Emotional Manifestation and Anxiety
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Apr 5, 2019
Actual Study Completion Date :
Apr 17, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Patient will undergo standard workflow for elective surgical admissions.

Experimental: Video

In addition to standard workflow, will also receive the intervention bundle which consists of a cartoon video and sets of activity sheets

Other: Video
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.

Outcome Measures

Primary Outcome Measures

  1. Children's Emotional Manifestation Scale [1 day]

    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'.

  2. Anxiety score [1 day]

    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.

  3. Feeling thermometer [1 day]

    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'.

Secondary Outcome Measures

  1. Visual analogue scale (VAS) [1 day]

    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.

  2. Induction compliance checklist (ICC) [1 day]

    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'.

  3. Admission feedback questionnaires [1 day]

    A modified version of the patient satisfaction survey currently used by KK Hospital to assess patient satisfaction with outpatient services

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Aged 4-10 years, male or female

  2. No prior surgical experience

  3. Able to communicate clearly, navigate simple technical software, be awake and alert

  4. Normal development

  5. Able to read and communicate in English

Exclusion Criteria:
  1. Abnormal development

  2. Has had prior surgical experience

  3. Is participating in another study

Contacts and Locations

Locations

Site City State Country Postal Code
1 KK Women's and Children's Hosptial Singapore Singapore 229899

Sponsors and Collaborators

  • KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Li Wei Chiang, MBBS, KK Women's and Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
KK Women's and Children's Hospital
ClinicalTrials.gov Identifier:
NCT04271553
Other Study ID Numbers:
  • CIRB 2017-2905
First Posted:
Feb 17, 2020
Last Update Posted:
Feb 17, 2020
Last Verified:
Feb 1, 2020
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 KK Women's and Children's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2020