Reducing Preoperative Anxiety in Parents of Surgical Patients
NCT ID: NCT04976114
Last Updated: 2021-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2016-10-01
2017-10-01
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
Standard of care
No interventions assigned to this group
story book
Parents read a book with the chid previous to surgery.
Story book with information about surgery techniques
Presurgery use of Story book. The parents with the child read a book with information about surgery techniques the days before surgery.
video
Parents watch a video with the chid previous to surgery.
Video with information about surgery techniques
Presurgery use of video. The parents with the child watch a video with information about surgery techniques the days before surgery.
both instrument
Parents read a book and watch a video with the chid previous to surgery.
Story book and Video with information about surgery techniques
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.
Interventions
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Story book with information about surgery techniques
Presurgery use of Story book. The parents with the child read a book with information about surgery techniques the days before surgery.
Video with information about surgery techniques
Presurgery use of video. The parents with the child watch a video with information about surgery techniques the days before surgery.
Story book and Video with information about surgery techniques
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Emergency surgery,
* Children not able to understand or read
* Parents not present or refused to participate.
8 Years
12 Years
ALL
No
Sponsors
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Hospital San Carlos, Madrid
OTHER
Responsible Party
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Emilio Vargas Castrillón
Head of clinical pharmacoloy hospital clinico san carlos
Other Identifiers
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preoperative anxiety
Identifier Type: -
Identifier Source: org_study_id
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