Clinical Trials Directory

Trials / Completed

CompletedNCT04976114

Reducing Preoperative Anxiety in Parents of Surgical Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
140 (actual)
Sponsor
Hospital San Carlos, Madrid · Academic / Other
Sex
All
Age
8 Years – 12 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREStory book with information about surgery techniquesPresurgery use of Story book. The parents with the child read a book with information about surgery techniques the days before surgery.
PROCEDUREVideo with information about surgery techniquesPresurgery use of video. The parents with the child watch a video with information about surgery techniques the days before surgery.
PROCEDUREStory book and Video with information about surgery techniquesPresurgery 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.

Timeline

Start date
2016-10-01
Primary completion
2017-10-01
Completion
2017-10-01
First posted
2021-07-26
Last updated
2021-07-26

Source: ClinicalTrials.gov record NCT04976114. Inclusion in this directory is not an endorsement.