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The Effect of Reading Book on Preoperative Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880942
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
gözde bumin aydın, Diskapi Yildirim Beyazit Education and Research Hospital

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

Condition or disease Intervention/treatment Phase
Preoperative Anxiety Other: Informative story book Other: Non Informative Story Book Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: The Effect of Reading an Informative Story Book on Preoperative Anxiety
Actual Study Start Date : May 2, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: 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.
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.
Other Name: Elif Ameliyat Oluyor

Placebo Comparator: 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.
Other: 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.
Other Name: Çiftlik Öyküleri-Kamp




Primary Outcome Measures :
  1. preoperative anxiety [ 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. ]

    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 :
  1. maternal anxiety [ Time Frame: It will be evaluated once. At the preoperative holding area while waiting for operation with their child. ]

    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.




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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880942


Locations
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Turkey
DiskapiYBERH
Ankara, Turkey
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
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Responsible Party: gözde bumin aydın, associate professor, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03880942    
Other Study ID Numbers: 55/13
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders