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The Effect of Reading Book on Preoperative Anxiety

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ClinicalTrials.gov Identifier: NCT03880942
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
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)
Estimated Enrollment : 100 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 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: At preoperative period at the preoperative waiting room before given premedication, in the operating room before anesthesia induction ]

    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: At preoperative period at the preoperative waiting room ]

    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


Contacts
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Contact: Bahar SAKIZCI UYAR 5057000240 drsakizciuyar@gmail.com

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     History of Changes
Other Study ID Numbers: 55/13
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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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