Preoperative AnxietyNCT03880942
The Effect of Reading Book on Preoperative Anxiety
A study testing Informative story book and Non Informative Story Book in people with Preoperative Anxiety, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Observe the effects of reading an informative story book on preoperative anxiety and maternal anxiety Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Informative story book and Non Informative Story Book
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA 1-2
- Elective surgery
Who cannot join
- Chronic diseases
- Development disability
- Prematurity
- Neurological diseases
- Psychoactive medication use
- Hearing/visual impairment
- History of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reading an Informative Story Book on Preoperative Anxiety
Observe the effects of reading an informative story book on preoperative anxiety and maternal anxiety
Read the 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.
- Conditions
- Preoperative Anxiety
- Being tested
- Informative story book, Non Informative Story Book
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informative story bookOther
Also called Elif Ameliyat Oluyor
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 BookOther
Also called Çiftlik Öyküleri-Kamp
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Non Informative Story Book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: It will be evaluated once. At the preoperative holding area while waiting for operation with their child.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start2 May 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, gözde bumin aydın, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880942
- Sponsor's protocol ID
- 55/13
- Status last verified
- Apr 2020
- First submitted
- 13 Mar 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reading an Informative Story Book on Preoperative Anxiety
- ClinicalTrials.gov ID
- NCT03880942
- Acronym / sponsor ID
- 55/13
- Conditions
- Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 2 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observe the effects of reading an informative story book on preoperative anxiety and maternal anxiety
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Informative Story Book | Active comparator | Other: Informative story bookPatients 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 comparator | Other: Non Informative Story BookPatients 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. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA 1-2
- Elective surgery
Key exclusion criteria (7 listed)
- Chronic diseases
- Development disability
- Prematurity
- Neurological diseases
- Psychoactive medication use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informative story bookAlso: Elif Ameliyat OluyorPatients 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 BookAlso: Çiftlik Öyküleri-KampPatients 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 |
Primary outcome
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.
1 secondary outcome
maternal anxiety
Time frame: It will be evaluated once. At the preoperative holding area while waiting for operation with their child.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informative story book and Non Informative Story Book in people with Preoperative Anxiety, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.