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Reducing Preoperative Anxiety in Parents of Surgical Patients

NCT04976114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-07-26

No results posted yet for this study

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

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2017-10-01
Completion
2017-10-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976114 on ClinicalTrials.gov