Reducing Preoperative Anxiety in Parents of Surgical Patients

NCT04976114 | Completed

• 1 other identifier: preoperative anxiety
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety level

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

  Presurgery, just the moment before to surgery

Study Arms (4)

Control group

NO INTERVENTION

Standard of care

story book

EXPERIMENTAL

Parents read a book with the chid previous to surgery.

Procedure: Story book with information about surgery techniques

video

EXPERIMENTAL

Parents watch a video with the chid previous to surgery.

Procedure: Video with information about surgery techniques

both instrument

EXPERIMENTAL

Parents read a book and watch a video with the chid previous to surgery.

Procedure: Story book and Video with information about surgery techniques

Interventions

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.

story book

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.

video

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.

both instrument

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Undergoing surgery at Asturias Central Hospital

You may not qualify if:

• Children not in the age range,
• Emergency surgery,
• Children not able to understand or read
• Parents not present or refused to participate.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical pharmacoloy hospital clinico san carlos

Model Details: 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)

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 26, 2021
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share