Reducing Preoperative Anxiety in Parents of Surgical Pati... | NCT04976114

Studies
Reducing Preoperative Anxiety in Parents of Surgical Patients

NCT04976114

Sponsor

Hospital San Carlos, Madrid

Status

Completed

Last Update Posted

Jul 26, 2021Actual

Enrollment

140Actual

Phase

Not Applicable

Conditions

Anxiety

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016Actual

Primary Completion Date

Oct 1, 2017Actual

Completion Date

Oct 1, 2017Actual

First Submitted Date

Jul 9, 2021

First Submission Date that Met QC Criteria

Jul 14, 2021

First Posted Date

Jul 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2021

Last Update Posted Date

Jul 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emilio Vargas Castrillón, Head of clinical pharmacoloy hospital clinico san carlos, Hospital San Carlos, MadridPrincipal Investigator

Lead Sponsor

Hospital San Carlos, MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

The results will be able after request with considerable reasons

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D014743	Videotape Recording

Ancestor Terms

ID	Term
D013637	Tape Recording
D001296	Audiovisual Aids
D018961	Educational Technology
D013672	Technology

Browse Leaves

Not provided

Browse Branches

Not provided

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)

Masking Info

Masking

Single

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.

Who Masked

Investigator