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Reducing Preoperative Anxiety in Parents of Surgical Patients

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Story book with information about surgery techniques
Video with information about surgery techniques
Story book and Video with information about surgery techniques
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control group

    story book

    video

    both instrument

    Arm Description

    Standard of care

    Parents read a book with the chid previous to surgery.

    Parents watch a video with the chid previous to surgery.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 9, 2021
    Last Updated
    July 14, 2021
    Sponsor
    Hospital San Carlos, Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04976114
    Brief Title
    Reducing Preoperative Anxiety in Parents of Surgical Patients
    Official Title
    Reducing Preoperative Anxiety in Parents of Surgical Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    October 1, 2017 (Actual)
    Study Completion Date
    October 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital San Carlos, Madrid

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    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.
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Standard of care
    Arm Title
    story book
    Arm Type
    Experimental
    Arm Description
    Parents read a book with the chid previous to surgery.
    Arm Title
    video
    Arm Type
    Experimental
    Arm Description
    Parents watch a video with the chid previous to surgery.
    Arm Title
    both instrument
    Arm Type
    Experimental
    Arm Description
    Parents read a book and watch a video with the chid previous to surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Story book with information about surgery techniques
    Intervention Description
    Presurgery use of Story book. The parents with the child read a book with information about surgery techniques the days before surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Video with information about surgery techniques
    Intervention Description
    Presurgery use of video. The parents with the child watch a video with information about surgery techniques the days before surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Story book and Video with information about surgery techniques
    Intervention Description
    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 Outcome Measure Information:
    Title
    Anxiety level
    Description
    Level of presurgery anxiety measured by State-Trait Anxiety Inventory scale
    Time Frame
    Presurgery, just the moment before to surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The results will be able after request with considerable reasons

    Learn more about this trial

    Reducing Preoperative Anxiety in Parents of Surgical Patients

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