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Reducing Preoperative Anxiety in Parents of Surgical Patients

Reducing Preoperative Anxiety in Parents of Surgical Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04976114
Enrollment
140
Registered
2021-07-26
Start date
2016-10-01
Completion date
2017-10-01
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

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

Interventions

PROCEDUREStory 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.

PROCEDUREVideo 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.

PROCEDUREStory 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

Hospital San Carlos, Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

As it is not possible for the participants to be blinded, they were asked not to mention to the assessment researchers (or other parents they could meet) what was the information they received, ensuring the researchers to remain blinded.

Intervention model description

A randomised and blind clinical trial. The parents could be randomly assigned to the control group, and received the standard procedure, or to the experimental groups. Three experimental groups were possible regarding the various types of interventions: story book (IG1), video (IG2), or both instruments (IG3)

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anxiety levelPresurgery, just the moment before to surgeryLevel of presurgery anxiety measured by State-Trait Anxiety Inventory scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026