Anxiety Clinical Trial
— HIPPOOfficial title:
"Prepare for Operation" Bundle for Young Children Undergoing Elective Surgery: Emotional Manifestation and Anxiety
Verified date | February 2020 |
Source | KK Women's and Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | April 17, 2019 |
Est. primary completion date | April 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 10 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children's Hosptial | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital |
Singapore,
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. — View Citation
He HG, Zhu L, Li HC, Wang W, Vehviläinen-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. — View 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. — View 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. Epub 2007 Jun 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | 1 day | |
Secondary | 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'. | 1 day | |
Secondary | Admission feedback questionnaires | A modified version of the patient satisfaction survey currently used by KK Hospital to assess patient satisfaction with outpatient services | 1 day |
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