Home-Initiated Programme to Prepare for Operation (HIPPO) Study (HIPPO)
"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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur, 229899
- KK Women's and Children's Hosptial
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control
Patient will undergo standard workflow for elective surgical admissions.
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Experimental: Video
In addition to standard workflow, will also receive the intervention bundle which consists of a cartoon video and sets of activity sheets
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Children's Emotional Manifestation Scale
Periodo de tiempo: 1 day
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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
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Anxiety score
Periodo de tiempo: 1 day
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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.
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1 day
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Feeling thermometer
Periodo de tiempo: 1 day
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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'.
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1 day
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Visual analogue scale (VAS)
Periodo de tiempo: 1 day
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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.
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1 day
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Induction compliance checklist (ICC)
Periodo de tiempo: 1 day
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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'.
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1 day
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Admission feedback questionnaires
Periodo de tiempo: 1 day
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A modified version of the patient satisfaction survey currently used by KK Hospital to assess patient satisfaction with outpatient services
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1 day
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Li Wei Chiang, MBBS, KK Women's and Children's Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CIRB 2017-2905
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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