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AnxietyHIPPONCT04271553

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

A study testing Video in people with Anxiety and Fear of Pain, run by KK Women's and Children's Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 4 to 10 years
Conditions the study is for
Anxiety, Fear of Pain, Child Behavior
What is being tested?
Video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteSingapore
Study dates
1 Feb 2018to 17 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • KK Women's and Children's Hosptial

    Singapore, 229899

Other trials in Singapore

About this study

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

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.

Read the 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.

Being tested
Video
Keywords
anxiety, pre-operation
Medical subject headings
Anxiety Disorders, Child Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04271553
Study groupRoleWhat they receive
ControlNo interventionPatient will undergo standard workflow for elective surgical admissions.
VideoExperimentalIn addition to standard workflow, will also receive the intervention bundle which consists of a cartoon video and sets of activity sheets
Receives: Other: Video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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'.

    Measured: 1 day

  2. 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.

    Measured: 1 day

  3. 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'.

    Measured: 1 day

Secondary outcomes (3)

  1. 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.

    Measured: 1 day

  2. 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'.

    Measured: 1 day

  3. Admission feedback questionnaires

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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start1 Feb 2018
  3. Primary completion5 Apr 2019
  4. Study completion17 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04271553
Sponsor's protocol ID
CIRB 2017-2905
Acronym
HIPPO
Status last verified
Feb 2020
First submitted
3 Nov 2019
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20124283

  • 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.

    PubMed 20432062

  • 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.

    PubMed 23991679

  • 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.

    PubMed 17608635

  • 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.

    PubMed 33186309

Questions about this trial

What is this clinical trial studying?

A study testing Video in people with Anxiety and Fear of Pain, run by KK Women's and Children's Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's Emotional Manifestation Scale (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04271553, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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HIPPO Clinical Trial NCT04271553 | AzTrials