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

Primary Purpose

Anxiety, Fear of Pain, Child Behavior

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Video
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety focused on measuring anxiety, pre-operation

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KK Women's and Children's Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Video

Arm Description

Patient will undergo standard workflow for elective surgical admissions.

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

Outcomes

Primary Outcome Measures

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'.
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.
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'.

Secondary Outcome Measures

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.
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'.
Admission feedback questionnaires
A modified version of the patient satisfaction survey currently used by KK Hospital to assess patient satisfaction with outpatient services

Full Information

First Posted
November 3, 2019
Last Updated
February 14, 2020
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04271553
Brief Title
Home-Initiated Programme to Prepare for Operation (HIPPO) Study
Acronym
HIPPO
Official Title
"Prepare for Operation" Bundle for Young Children Undergoing Elective Surgery: Emotional Manifestation and Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Fear of Pain, Child Behavior
Keywords
anxiety, pre-operation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
prospective blinded (assessor) randomized controlled trial
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patient will undergo standard workflow for elective surgical admissions.
Arm Title
Video
Arm Type
Experimental
Arm Description
In addition to standard workflow, will also receive the intervention bundle which consists of a cartoon video and sets of activity sheets
Intervention Type
Other
Intervention Name(s)
Video
Intervention Description
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 Outcome Measure Information:
Title
Children's Emotional Manifestation Scale
Description
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'.
Time Frame
1 day
Title
Anxiety score
Description
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.
Time Frame
1 day
Title
Feeling thermometer
Description
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'.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
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.
Time Frame
1 day
Title
Induction compliance checklist (ICC)
Description
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'.
Time Frame
1 day
Title
Admission feedback questionnaires
Description
A modified version of the patient satisfaction survey currently used by KK Hospital to assess patient satisfaction with outpatient services
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Wei Chiang, MBBS
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hosptial
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20124283
Citation
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.
Results Reference
background
PubMed Identifier
20432062
Citation
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. Erratum In: J Abnorm Child Psychol. 2010 Oct;38(7):895.
Results Reference
background
PubMed Identifier
23991679
Citation
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.
Results Reference
background
PubMed Identifier
17608635
Citation
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.
Results Reference
background
PubMed Identifier
33186309
Citation
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.
Results Reference
derived

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

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