Reducing Preoperative Anxiety in Parents of Surgical Patients

Anxiety Clinical Trial

Official title:

Reducing Preoperative Anxiety in Parents of Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976114
• Other study ID #: preoperative anxiety
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: July 2021
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level	Level of presurgery anxiety measured by State-Trait Anxiety Inventory scale	Presurgery, just the moment before to surgery