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

About this trial
This is an interventional treatment trial for Anxiety
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.
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
NCT ID
NCT04976114
First Posted
July 9, 2021
Last Updated
July 14, 2021
Sponsor
Hospital San Carlos, Madrid
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
We'll reach out to this number within 24 hrs