The Effect of Reading Book on Preoperative Anxiety
The Effect of Reading an Informative Story Book on Preoperative Anxiety
1 other identifier
interventional
120
1 country
1
Brief Summary
Observe the effects of reading an informative story book on preoperative anxiety and maternal anxiety
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedStudy Start
First participant enrolled
May 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedApril 27, 2020
April 1, 2020
8 months
March 13, 2019
April 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Preoperative anxiety will be evaluated at two times. At the preoperative holding area before given premedication and while entering to the operating room.
Secondary Outcomes (1)
maternal anxiety
It will be evaluated once. At the preoperative holding area while waiting for operation with their child.
Study Arms (2)
Informative Story Book
ACTIVE COMPARATORPatients 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.
Non Informative Story Book
PLACEBO COMPARATORPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- ASA 1-2
- Elective surgery
You may not qualify if:
- Chronic diseases
- Development disability
- Prematurity
- Neurological diseases
- Psychoactive medication use
- Hearing/visual impairment
- History of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DiskapiYBERH
Ankara, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
March 13, 2019
First Posted
March 19, 2019
Study Start
May 2, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
April 27, 2020
Record last verified: 2020-04