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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03880942
Other study ID # 55/13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2019
Est. completion date December 31, 2019

Study information

Verified date April 2020
Source Diskapi Yildirim Beyazit Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Observe the effects of reading an informative story book on preoperative anxiety and maternal anxiety


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Informative story book
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.
Non Informative Story Book
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.

Locations

Country Name City State
Turkey DiskapiYBERH Ankara

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
It will be evaluated once. At the preoperative holding area while waiting for operation with their child.
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