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Clinical Trials/NCT04976114
NCT04976114
Completed
Not Applicable

Reducing Preoperative Anxiety in Parents of Surgical Patients

Hospital San Carlos, Madrid0 sites140 target enrollmentOctober 1, 2016
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Hospital San Carlos, Madrid
Enrollment
140
Primary Endpoint
Anxiety level
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
October 1, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emilio Vargas Castrillón

Head of clinical pharmacoloy hospital clinico san carlos

Hospital San Carlos, Madrid

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Anxiety level

Time Frame: Presurgery, just the moment before to surgery

Level of presurgery anxiety measured by State-Trait Anxiety Inventory scale

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