NCT03880942

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

March 13, 2019

Last Update Submit

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 COMPARATOR

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

Non Informative Story Book

PLACEBO COMPARATOR

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

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.

Also known as: Elif Ameliyat Oluyor
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.

Also known as: Çiftlik Öyküleri-Kamp
Non Informative Story Book

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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)

Location

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

Locations