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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04851626




Registration number
NCT04851626
Ethics application status
Date submitted
8/04/2021
Date registered
20/04/2021
Date last updated
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
2/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2020
Sample size
Target
Accrual to date
Final
14
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
Objective: To establish whether the pilot online hypnosis design was well received by women
with persistent pelvic pain and worthy of a full randomised control trial To establish
whether hypnosis improves mental health outcomes, including anxiety, depression, life impact
and catastrophizing, in women with chronic pelvic pain conditions.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04851626
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04851626