Reducing Preoperative Anxiety in Parents of Surgical Patients

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: 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

• Registration Number: NCT04976114
• Lead Sponsor: Hospital San Carlos, Madrid

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Study First Posted: 2021-07-26
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
story book	Story book with information about surgery techniques	Parents read a book with the chid previous to surgery.
video	Video with information about surgery techniques	Parents watch a video with the chid previous to surgery.
both instrument	Story book and Video with information about surgery techniques	Parents read a book and watch a video with the chid previous to surgery.

Primary Outcome Measures

Name	Time	Method
Anxiety level	Presurgery, just the moment before to surgery	Level of presurgery anxiety measured by State-Trait Anxiety Inventory scale