ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Surgery

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]

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]

Using a between-groups design, the primary outcome measured was PTSD following ritual circumcision as compared with that occurring after medical circumcision.

Timepoint [1]

The Watson et al. PTSD scale was administered to the boys from both groups following completion of the circumcision procedures

Secondary outcome [1]

Experience of the circumcision as assessed by 7-point Likert-type rating scale.

Timepoint [1]

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?

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]

Philippines

State/province [1]

Batangas

Funding & Sponsors

Funding source category [1]

University

Name [1]

Bond University

Address [1]

University Drive, Robina, Gold Coast, QLD 4229, Australia

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human Research Ethics Committee (BUHREC)

Ethics committee address [1]

a) University Drive, Robina, QLD 4229, AUSTRALIA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/03/1999

Approval date [1]

16/03/1999

Ethics approval number [1]

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

Prof Gregory J. Boyle

Address

C/- Bond University, Gold Coast, QLD 4229, AUSTRALIA

Country

Australia

Phone

+61 7 55951111

Fax

[email protected]

Contact person for public queries

Name

Gregory J. Boyle

Address

C/- University of Melbourne, Parkville, VIC 3010, AUSTRALIA

Country

Australia

Phone

+61 3 90355511

Fax

[email protected]

Contact person for scientific queries

Name

Gregory J. Boyle

Address

C/- University of Melbourne, Parkville, VIC 3010, AUSTRALIA

Country

Australia

Phone

+61 3 90355511

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Dimensions AI	Post-traumatic stress disorder (PTSD) among Filipino boys subjected to non-therapeutic ritual or medical surgical procedures: A retrospective cohort study	2019	https://doi.org/10.1016/j.amsu.2019.04.004

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically