NCT04271553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

November 3, 2019

Last Update Submit

February 14, 2020

Conditions

AnxietyFear of PainChild Behavior

Keywords

anxietypre-operation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Visual analogue scale (VAS)

    1 day

  • Induction compliance checklist (ICC)

    1 day

  • Admission feedback questionnaires

    1 day

Study Arms (2)

Control

NO INTERVENTION

Patient will undergo standard workflow for elective surgical admissions.

Video

EXPERIMENTAL

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

Other: Video

Interventions

VideoOTHER

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.

Video

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Abnormal development
  • Has had prior surgical experience
  • Is participating in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hosptial

Singapore, 229899, Singapore

Location

Related Publications (5)

  • Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Br J Anaesth. 2010 Mar;104(3):369-74. doi: 10.1093/bja/aeq002. Epub 2010 Feb 1.

    PMID: 20124283BACKGROUND

  • Burstein M, Ginsburg GS, Tein JY. Parental anxiety and child symptomatology: an examination of additive and interactive effects of parent psychopathology. [corrected]. J Abnorm Child Psychol. 2010 Oct;38(7):897-909. doi: 10.1007/s10802-010-9415-0.

    PMID: 20432062BACKGROUND

  • He HG, Zhu L, Li HC, Wang W, Vehvilainen-Julkunen K, Chan SW. A randomized controlled trial of the effectiveness of a therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: study protocol. J Adv Nurs. 2014 Feb;70(2):431-42. doi: 10.1111/jan.12234. Epub 2013 Aug 29.

    PMID: 23991679BACKGROUND

  • Li HC. Evaluating the effectiveness of preoperative interventions: the appropriateness of using the Children's Emotional Manifestation Scale. J Clin Nurs. 2007 Oct;16(10):1919-26. doi: 10.1111/j.1365-2702.2007.01784.x. Epub 2007 Jun 30.

    PMID: 17608635BACKGROUND

  • Nair T, Choo CSC, Abdullah NS, Lee S, Teo LLE, Chen Y, Nah SA, Chiang LW. Home-Initiated-Programme-to-Prepare-for-Operation: evaluating the effect of an animation video on peri-operative anxiety in children: A randomised controlled trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):880-887. doi: 10.1097/EJA.0000000000001385.

    PMID: 33186309DERIVED

MeSH Terms

Conditions

Anxiety DisordersChild Behavior

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Li Wei Chiang, MBBS

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
prospective blinded (assessor) randomized controlled trial
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2019

First Posted

February 17, 2020

Study Start

February 1, 2018

Primary Completion

April 5, 2019

Study Completion

April 17, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)