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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04851626




Registration number
NCT04851626
Ethics application status
Date submitted
8/04/2021
Date registered
20/04/2021

Titles & IDs
Public title
Hypnotic Intervention for Women With Chronic Pelvic Pain
Scientific title
Hypnotic Intervention for Women With Chronic Pelvic Pain: a Pilot Randomised Control Trial
Secondary ID [1] 0 0
202935
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 0 0
Pelvic Pain 0 0
Psychological 0 0
Hypnosis, Animal 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Hypnotic intervention for persistent pelvic pain.
Other interventions - Control group persistent pelvic pain no intervention.

Experimental: Intervention group - hypnotic intervention for persistent pelvic pain - Participants underwent education about persistent pain and a 7 week 7 recording online hypnotic intervention. Women with persistent pelvic pain.

Other: Control group - waitlist control - Control group of women with persistent pelvic pain no intervention completed assessment and concluding measures but did not undergo hypnotic intervention.


Other interventions: Hypnotic intervention for persistent pelvic pain.
Education about persistent pelvic pain followed by 7 recordings of hypnosis intervention across 7 weeks accessed online through recordings.

Other interventions: Control group persistent pelvic pain no intervention.
Control group no hypnotic intervention. Waitlist control.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of hypnotic intervention according to qualitative responses from women with persistent pelvic pain.
Timepoint [1] 0 0
7 weeks
Secondary outcome [1] 0 0
Impact on pain severity as indicated on a visual analogue scale (10 point).
Timepoint [1] 0 0
7 weeks
Secondary outcome [2] 0 0
Impact on depression scores on the Patient Health Questionnaire nine-item scale
Timepoint [2] 0 0
7 weeks
Secondary outcome [3] 0 0
Impact on anxiety scores on the Generalised Anxiety Disorder scale seven-item
Timepoint [3] 0 0
7 weeks

Eligibility
Key inclusion criteria
* Meets criteria for persistent pelvic pain. Having experienced pain in the pelvic region below the umbilicus for over three months either beyond the healing time of a pathology or injury or without a diagnosed cause.
* Must be biologically female.
* Must be over the age of 18 years old.
Minimum age
18 Years
Maximum age
100 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Must not have a previously diagnosed or current mental health disorder involving dissociative states. Examples include diagnosed or current symptoms of Bipolar Type 1 or 2, psychotic disorders, untreated Post-Traumatic Stress Disorder.
* Must not reported current plan or intent to commit suicide.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of South Australia - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of South Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tiffany Brooks
Address 0 0
University of South Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Permission was only sought for participants in this study.


What supporting documents are/will be available?

Results publications and other study-related documents

No documents have been uploaded by study researchers.