Clinical trial NCT04851626: Hypnotic Intervention for Women With Chronic Pelvic Pain
Official title: Hypnotic Intervention for Women With Chronic Pelvic Pain: a Pilot Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Pelvic Pain
Psychological
Hypnosis, Animal
Lead sponsor: University of South Australia
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot randomised controlled trial with 2 parallel study arms.
Primary purpose: TREATMENT

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.

Detailed description: Design: Pilot Randomised Control Trial Methods: Twenty women with persistent pelvic pain completed assessment questionnaires and were recruited from a variety of social media sites related to persistent pelvic pain and randomly allocated to either control or hypnotic intervention groups. The intervention group completed a seven week online hypnotic intervention. The control group received no intervention. Both groups completed assessment and concluding questionnaires related to demographic information and the outcomes of interest. This included measures for anxiety, depression, pain, coping styles, pain related disability, pain catastrophizing and suggestibility. The results of the intervention and waitlist control groups were compared using linear mixed-effects modelling. Suggestibility was screened for at baseline using the Short Suggestibility Scale, and included in a secondary set of linear effects modelling.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Feasibility of hypnotic intervention according to qualitative responses from women with persistent pelvic pain.
timeFrame: 7 weeks
Secondary outcomes:
measure: Impact on pain severity as indicated on a visual analogue scale (10 point).
timeFrame: 7 weeks
measure: Impact on depression scores on the Patient Health Questionnaire nine-item scale
timeFrame: 7 weeks
measure: Impact on anxiety scores on the Generalised Anxiety Disorder scale seven-item
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of South Australia
state: South Australia
Study officials:
affiliation: University of South Australia
name: Tiffany Brooks
role: PRINCIPAL_INVESTIGATOR
References: