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OpenTrials
Completed

NCT Number: NCT04976114

Reducing Preoperative Anxiety in Parents of Surgical Patients

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

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Story book with information about surgery techniques

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. Anxiety level

    Time frame: Presurgery, just the moment before to surgery

    Level of presurgery anxiety measured by State-Trait Anxiety Inventory scale

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2021
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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