Hypnotic Intervention for Women With Chronic Pelvic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2020-12-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pain Pelvic Pain Psychological Hypnosis, Animal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot randomised controlled trial with 2 parallel study arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking not feasible for pilot design.

Study Groups

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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.

Group Type EXPERIMENTAL

Hypnotic intervention for persistent pelvic pain.

Intervention Type OTHER

Education about persistent pelvic pain followed by 7 recordings of hypnosis intervention across 7 weeks accessed online through recordings.

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.

Group Type OTHER

Control group persistent pelvic pain no intervention.

Intervention Type OTHER

Control group no hypnotic intervention. Waitlist control.

Interventions

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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.

Intervention Type OTHER

Control group persistent pelvic pain no intervention.

Control group no hypnotic intervention. Waitlist control.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No