Reducing Preoperative Anxiety in Parents of Surgical Patients

S

San Carlos Clinical Hospital

Status

Completed

Conditions

Anxiety

Treatments

Procedure: Video with information about surgery techniques
Procedure: Story book with information about surgery techniques
Procedure: Story book and Video with information about surgery techniques

Study type

Interventional

Funder types

Other

Identifiers

NCT04976114
preoperative anxiety

Details and patient eligibility

About

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

Enrollment

140 patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 4 patient groups

Control group
No Intervention group
Description:
Standard of care
story book
Experimental group
Description:
Parents read a book with the chid previous to surgery.
Treatment:
Procedure: Story book with information about surgery techniques
video
Experimental group
Description:
Parents watch a video with the chid previous to surgery.
Treatment:
Procedure: Video with information about surgery techniques
both instrument
Experimental group
Description:
Parents read a book and watch a video with the chid previous to surgery.
Treatment:
Procedure: Story book and Video with information about surgery techniques

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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