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The Effect of Reading Book on Preoperative Anxiety

Primary Purpose

Preoperative Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Informative story book
Non Informative Story Book
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preoperative Anxiety

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA 1-2
  • Elective surgery

Exclusion Criteria:

  • Chronic diseases
  • Development disability
  • Prematurity
  • Neurological diseases
  • Psychoactive medication use
  • Hearing/visual impairment
  • History of surgery

Sites / Locations

  • DiskapiYBERH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Informative Story Book

Non Informative Story Book

Arm Description

Patients will be given a colorful story book that tells the hospital and operation procedure named 'Elif Ameliyat Oluyor'(Elif is undergoing surgery) and will be asked to read the book with children at least once before the operation.

Patients will be given a non-medical colorful story book called 'Çiftlik Öyküleri-Kamp' (Farm Stories-Camp) and will be asked to read the book with children at least once before the operation.

Outcomes

Primary Outcome Measures

preoperative anxiety
Preoperative anxiety will be evaluated by mYPAS (modified Yale Preoperative Anxiety Scale) The mYPAS consists of 22 items in five categories (activity, emotional expressivity, state of arousal, vocalization and use of parents). The highest behavioral level observed in each of the five mYPAS categories is the score for that category. Partial weights were calculated and then added to a total score that ranged from 0 to 100. Cut off points were set to classify: a score of 23.4 to 30 for no anxiety, any score greater than 30 for anxiety. Preoperative anxiety at preoperative waiting room and at operation room will be evaluated.

Secondary Outcome Measures

maternal anxiety
Maternal state anxiety will be evaluated by STAI-FORM TX1 questionnaire at preoperative waiting room. The STAI TX1 is an internationally well accepted measure and has been used in a range of comparable studies for assessing the level of parents'anxiety. Raw scores on each subscale range between 20 and 80, with higher scores reflecting higher levels of anxiety.

Full Information

First Posted
March 13, 2019
Last Updated
April 24, 2020
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03880942
Brief Title
The Effect of Reading Book on Preoperative Anxiety
Official Title
The Effect of Reading an Informative Story Book on Preoperative Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
Observe the effects of reading an informative story book on preoperative anxiety and maternal anxiety
Detailed Description
Observe the effects of reading an informative story book at preoperative period on preoperative anxiety by m-YPAS in the holding area and on maternal anxiety by STAI in the holding area.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Informative Story Book
Arm Type
Active Comparator
Arm Description
Patients will be given a colorful story book that tells the hospital and operation procedure named 'Elif Ameliyat Oluyor'(Elif is undergoing surgery) and will be asked to read the book with children at least once before the operation.
Arm Title
Non Informative Story Book
Arm Type
Placebo Comparator
Arm Description
Patients will be given a non-medical colorful story book called 'Çiftlik Öyküleri-Kamp' (Farm Stories-Camp) and will be asked to read the book with children at least once before the operation.
Intervention Type
Other
Intervention Name(s)
Informative story book
Other Intervention Name(s)
Elif Ameliyat Oluyor
Intervention Description
Patients will be given a colorful story book that tells the hospital and operation procedure named 'Elif Ameliyat Oluyor'(Elif is undergoing surgery) and will be asked to read the book with children at least once before the operation.
Intervention Type
Other
Intervention Name(s)
Non Informative Story Book
Other Intervention Name(s)
Çiftlik Öyküleri-Kamp
Intervention Description
Patients will be given a non-medical colorful story book called 'Çiftlik Öyküleri-Kamp' (Farm Stories-Camp) and will be asked to read the book with children at least once before the operation.
Primary Outcome Measure Information:
Title
preoperative anxiety
Description
Preoperative anxiety will be evaluated by mYPAS (modified Yale Preoperative Anxiety Scale) The mYPAS consists of 22 items in five categories (activity, emotional expressivity, state of arousal, vocalization and use of parents). The highest behavioral level observed in each of the five mYPAS categories is the score for that category. Partial weights were calculated and then added to a total score that ranged from 0 to 100. Cut off points were set to classify: a score of 23.4 to 30 for no anxiety, any score greater than 30 for anxiety. Preoperative anxiety at preoperative waiting room and at operation room will be evaluated.
Time Frame
Preoperative anxiety will be evaluated at two times. At the preoperative holding area before given premedication and while entering to the operating room.
Secondary Outcome Measure Information:
Title
maternal anxiety
Description
Maternal state anxiety will be evaluated by STAI-FORM TX1 questionnaire at preoperative waiting room. The STAI TX1 is an internationally well accepted measure and has been used in a range of comparable studies for assessing the level of parents'anxiety. Raw scores on each subscale range between 20 and 80, with higher scores reflecting higher levels of anxiety.
Time Frame
It will be evaluated once. At the preoperative holding area while waiting for operation with their child.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA 1-2 Elective surgery Exclusion Criteria: Chronic diseases Development disability Prematurity Neurological diseases Psychoactive medication use Hearing/visual impairment History of surgery
Facility Information:
Facility Name
DiskapiYBERH
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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The Effect of Reading Book on Preoperative Anxiety

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