Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000589189
Ethics application status
Approved
Date submitted
7/04/2019
Date registered
16/04/2019
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Date results information initially provided
16/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post-traumatic Stress Disorder (PTSD) among Filipino Boys Subjected to Ritual or Medical Surgical Procedures
Scientific title
Post-traumatic Stress Disorder (PTSD) among Filipino Boys Subjected to Ritual or Medical Surgical Procedures: A Prospective Cohort Study
Secondary ID [1] 297907 0
None
Universal Trial Number (UTN)
U1111-1231-2691
Trial acronym
PTSDFBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-therapeutic male circumcision of normal, healthy (non-diseased) boys 312289 0
Condition category
Condition code
Surgery 310838 310838 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
a) Boys voluntarily completed the Watson et al. PTSD survey, plus a brief demographics questionnaire providing background information including age, feelings before the intervention (fear, anger, other), motivation for undergoing the non-therapeutic surgical (circumcision) intervention (social, religious, medical/health, other).
b) Duration of observation was from 1 year after the surgical (circumcision) intervention up to 3 years thereafter.
Intervention code [1] 314135 0
Not applicable
Comparator / control treatment
505 boys subjected to ritual circumcision ("Tuli") were compared with 1072 boys subjected to circumcision conducted by medically-trained operators.
Control group
Active

Outcomes
Primary outcome [1] 319677 0
Using a between-groups design, the primary outcome measured was PTSD following ritual circumcision as compared with that occurring after medical circumcision.
Timepoint [1] 319677 0
The Watson et al. PTSD scale was administered to the boys from both groups following completion of the circumcision procedures
Secondary outcome [1] 369134 0
Experience of the circumcision as assessed by 7-point Likert-type rating scale.
Timepoint [1] 369134 0
1 year post-procedure to 3-years post procedure.

Eligibility
Key inclusion criteria
Normal, healthy (non-diseased) boys aged 11 to 16 years with no previous history of psychological trauma or pre-existing PTSD symptoms who were already undergoing circumcision were included in this study. Boys who reported pre-existing psychological or PTSD symptoms who were undergoing the intervention were excluded from this study.
Minimum age
10 Years
Maximum age
15 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
a) Age of circumcision not between 7-16 years.
b) Age of respondents not between 11-16 years
c) Boys reporting pre-existing history of trauma or PTSD.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Chi-square tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/1996
Date of last participant enrolment
Anticipated
Actual
4/04/1997
Date of last data collection
Anticipated
Actual
7/04/2000
Sample size
Target
3000
Accrual to date
Final
3253
Recruitment outside Australia
Country [1] 21388 0
Philippines
State/province [1] 21388 0
Batangas

Funding & Sponsors
Funding source category [1] 302425 0
University
Name [1] 302425 0
Bond University
Country [1] 302425 0
Australia
Primary sponsor type
Individual
Name
Samuel Ramos
Address
C/- Bond University, Gold Coast, QLD 4229, AUSTRALIA (1999-2000)
Country
Australia
Secondary sponsor category [1] 302326 0
None
Name [1] 302326 0
N/A
Address [1] 302326 0
N/A
Country [1] 302326 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303095 0
Bond University Human Research Ethics Committee (BUHREC)
Ethics committee address [1] 303095 0
a) University Drive, Robina, QLD 4229, AUSTRALIA
Ethics committee country [1] 303095 0
Australia
Date submitted for ethics approval [1] 303095 0
02/03/1999
Approval date [1] 303095 0
16/03/1999
Ethics approval number [1] 303095 0

Summary
Brief summary
To assess proportion of boys suffering from PTSD following ritual circumcision ("Tuli) vs. medical circumcision, respectively.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 92450 0
Prof Gregory J. Boyle
Address 92450 0
C/- Bond University, Gold Coast, QLD 4229, AUSTRALIA
Country 92450 0
Australia
Phone 92450 0
+61 7 55951111
Fax 92450 0
Email 92450 0
[email protected]
Contact person for public queries
Name 92451 0
Prof Gregory J. Boyle
Address 92451 0
C/- University of Melbourne, Parkville, VIC 3010, AUSTRALIA
Country 92451 0
Australia
Phone 92451 0
+61 3 90355511
Fax 92451 0
Email 92451 0
[email protected]
Contact person for scientific queries
Name 92452 0
Prof Gregory J. Boyle
Address 92452 0
C/- University of Melbourne, Parkville, VIC 3010, AUSTRALIA
Country 92452 0
Australia
Phone 92452 0
+61 3 90355511
Fax 92452 0
Email 92452 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
Study was completed in March 2000 (thesis submitted in April 2000). To the best of my knowledge, the IPD was stored for many years at Bond University, but was eventually disposed of by the university.


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
SourceTitleYear of PublicationDOI
Dimensions AIPost-traumatic stress disorder (PTSD) among Filipino boys subjected to non-therapeutic ritual or medical surgical procedures: A retrospective cohort study2019https://doi.org/10.1016/j.amsu.2019.04.004
N.B. These documents automatically identified may not have been verified by the study sponsor.