Reducing Preoperative Anxiety in Parents of Surgical Patients

Study Overview
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Brief Summary
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Aims and objectives: To investigate preoperative anxiety in parents of paediatric surgical patients, testing whether the provision of information (using video and story books) regarding the surgical process can impact on reducing anxiety. Analyse if some personal factors influence the reduction of anxiety. Background: Attending a surgical theatre generates anxiety in all types of patients, especially in the case of children. The effect of different preoperative intervention procedures in children that attempt to reduce their anxiety level have been studied a great deal. However, although their parents also suffer high anxiety levels, potential intervention to reduce their levels have not received the same attention. Study design: Randomised Clinical trial Methods: One hundred and twenty-five parents of children (8-12 y.o.) undergoing surgery in Hospital Universitario Central de Asturias hospital (Oviedo, Spain) were randomly assigned to the control group (34 individuals) or one of the 3 experimental groups (91). After the pre-anaesthesia consultation, children and parents of the experimental groups were provided with a story book, a video with additional information of nursing, or both. In the antechamber of the operating room and prior to the surgical intervention, the State Anxiety and Trait Anxiety of the parents and children were measured using the STAI and STAIC questionnaires respectively. The data collection, including different demographic variables was carried out for 12 months starting in October 2016

Official Title
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Reducing Preoperative Anxiety in Parents of Surgical Patients

Conditions
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Anxiety

Intervention / Treatment
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* Procedure: Story book with information about surgery techniques
* Procedure: Video with information about surgery techniques
* Procedure: Story book and Video with information about surgery techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing surgery at Asturias Central Hospital Exclusion Criteria: Children not in the age range, Emergency surgery, Children not able to understand or read Parents not present or refused to participate.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomised and blind clinical trial. The parents could be randomly assigned to the control group, and received the standard procedure, or to the experimental groups. Three experimental groups were possible regarding the various types of interventions: story book (IG1), video (IG2), or both instruments (IG3)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Standard of care | |
| Experimental: story book<br>Parents read a book with the chid previous to surgery. | Procedure: Story book with information about surgery techniques<br>* Presurgery use of Story book. The parents with the child read a book with information about surgery techniques the days before surgery.<br>|
| Experimental: video<br>Parents watch a video with the chid previous to surgery. | Procedure: Video with information about surgery techniques<br>* Presurgery use of video. The parents with the child watch a video with information about surgery techniques the days before surgery.<br>|
| Experimental: both instrument<br>Parents read a book and watch a video with the chid previous to surgery. | Procedure: Story book and Video with information about surgery techniques<br>* Presurgery use of video and story book. The parents with the child watch a video and read a book (both) with information about surgery techniques the days before surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level | Level of presurgery anxiety measured by State-Trait Anxiety Inventory scale | Presurgery, just the moment before to surgery |