Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000645156p
Ethics application status
Submitted, not yet approved
Date submitted
17/04/2019
Date registered
30/04/2019
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Anxiety Following Multimedia Based Patient Education in Subjects Undergoing Office Hysteroscopy
Scientific title
Anxiety Scores Following Multimedia Based Patient Education in Patients Undergoing Office hysteroscopy
Secondary ID [1] 297998 0
None
Universal Trial Number (UTN)
Trial acronym
ASPE (Anxiety Scores following multimedia based Patient Education in patients undergoing office hysteroscopy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abnormal Uterine Bleeding 312425 0
Condition category
Condition code
Reproductive Health and Childbirth 310984 310984 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Demographic data will be obtained before the procedure.
State-Trait Anxiety Inventory scores will be obtained before the procedure and After video education (2 times)
Following the first State-Trait Anxiety Inventory patients allocated to multimedia education will receive approximately 5 minutes of video education concerning demonstration of the procedure. Control group will not receive video education. A 10 years nursing-staff will manage the State-Trait Anxiety Inventory.
Hysteroscopy will be carried out with using a 5.5mm hysteroscope in the office setting without anesthesia. Hysteroscopy will be performed by an 8 years experienced gynecologist (Aysu Akca)
Following the procedure, a visual analog scale (VAS) will be applied to subjects to address procedural satisfaction.
Intervention code [1] 314222 0
Behaviour
Comparator / control treatment
The intervention group will receive a video-based education before hysteroscopy, the control group will receive short verbal information concerning the procedure. Controls will respond to the State-Trait Anxiety Inventory before and after hysteroscopy.
Control group
Active

Outcomes
Primary outcome [1] 319784 0
Change in State-Trait Anxiety Inventory from baseline to watching video
Timepoint [1] 319784 0
Before and after video education. Before hysteroscopy.
Secondary outcome [1] 369533 0
Postprocedural satisfaction measured with visual analog scale (VAS)
Timepoint [1] 369533 0
15 minutes after the procedure

Eligibility
Key inclusion criteria
Subjects undergoing diagnostic hysteroscopy for abnormal uterine bleeding
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
psychological disease
contraindication for hysteroscopy
visual or auditory deficit

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/05/2019
Actual
Date of last participant enrolment
Anticipated
15/07/2019
Actual
Date of last data collection
Anticipated
30/07/2019
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment outside Australia
Country [1] 21417 0
Turkey
State/province [1] 21417 0
Istanbul

Funding & Sponsors
Funding source category [1] 302524 0
Self funded/Unfunded
Name [1] 302524 0
Aysu Akca
Country [1] 302524 0
Turkey
Primary sponsor type
Hospital
Name
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital
Address
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul
Country
Turkey
Secondary sponsor category [1] 302434 0
University
Name [1] 302434 0
University of Health Sciences
Address [1] 302434 0
Mekteb-i Tibbiye-i Sahane (Haydarpasa) Külliyesi Selimiye Mah. Tibbiye Cad. No:38 34668 Üsküdar, Istanbul
Country [1] 302434 0
Turkey

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303175 0
University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital
Ethics committee address [1] 303175 0
University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, AtakentMah. Turgut Özal Cad. No:1 Küçükçekmece, Istanbul, Turkey
Ethics committee country [1] 303175 0
Turkey
Date submitted for ethics approval [1] 303175 0
01/03/2019
Approval date [1] 303175 0
Ethics approval number [1] 303175 0

Summary
Brief summary
Patients undergoing diagnostic hysteroscopy for abnormal uterine bleeding will be randomized to intervention or control group. Both groups will complete the State-Trait Anxiety Inventory (STAI-T) before the procedure. The intervention group will then receive a video education and control group will receive verbal information. State-Trait Anxiety Inventory will be repeated following education. Then patients will undergo hysteroscopy in the office setting without anesthesia. Following hysteroscopy, a visual analog scale (VAS) will be responded by the participants to address patients satisfaction. The primary outcome is change in between baseline STAI-T and post-education STAI-T.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92746 0
Dr Aysu Akca
Address 92746 0
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, AtakentMah. Turgut Özal Cad. No:1 Küçükçekmece, Istanbul, Turkey
Country 92746 0
Turkey
Phone 92746 0
+902124041500
Fax 92746 0
Email 92746 0
[email protected]
Contact person for public queries
Name 92747 0
Dr Aysu Akca
Address 92747 0
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, AtakentMah. Turgut Özal Cad. No:1 Küçükçekmece, Istanbul, Turkey
Country 92747 0
Turkey
Phone 92747 0
+902124041500
Fax 92747 0
Email 92747 0
[email protected]
Contact person for scientific queries
Name 92748 0
Dr Aysu Akca
Address 92748 0
Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, AtakentMah. Turgut Özal Cad. No:1 Küçükçekmece, Istanbul, Turkey
Country 92748 0
Turkey
Phone 92748 0
+902124041500
Fax 92748 0
Email 92748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.