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Completed

NCT Number: NCT04271553

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Child Behavior Fear of Pain Mental Disorders

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hosptial

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video

Other

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.

Primary outcomes

  1. Children's Emotional Manifestation Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Visual analogue scale (VAS)

    Time frame: 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)

    Time frame: 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

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Acronym: HIPPO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2020
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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