Hypnotic Intervention for Women With Chronic Pelvic Pain

NCT04851626 | Completed DMC

• 1 other identifier: 202935
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Pelvic Pain; Psychological; Hypnosis, Animal

Outcome Measures

Primary Outcomes (1)

• Feasibility of hypnotic intervention according to qualitative responses from women with persistent pelvic pain.

  Whether hypnosis was received well by women with persistent pelvic pain in the intervention group according to their qualitative responses during and after the study. Qualitative responses were collected in open text box format and analysed for themes using the thematic analysis software contained in the SurveyMonkey online software. There are no minimum, maximum or total scores as this was a free text response format.

  7 weeks

Secondary Outcomes (3)

• Impact on pain severity as indicated on a visual analogue scale (10 point).

  7 weeks

• Impact on depression scores on the Patient Health Questionnaire nine-item scale

  7 weeks

• Impact on anxiety scores on the Generalised Anxiety Disorder scale seven-item

  7 weeks

Study Arms (2)

Intervention group - hypnotic intervention for persistent pelvic pain

EXPERIMENTAL

Participants underwent education about persistent pain and a 7 week 7 recording online hypnotic intervention. Women with persistent pelvic pain.

Other: Hypnotic intervention for persistent pelvic pain.

Control group - waitlist control

OTHER

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

Other: Control group persistent pelvic pain no intervention.

Interventions

Hypnotic intervention for persistent pelvic pain. OTHER

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

Intervention group - hypnotic intervention for persistent pelvic pain

Control group persistent pelvic pain no intervention. OTHER

Control group no hypnotic intervention. Waitlist control.

Control group - waitlist control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Australia: lead

Study Sites (1)

University of South Australia

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Chronic Pain; Pelvic Pain; Immobility Response, Tonic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Motor Activity

Study Officials

• Tiffany Brooks

  University of South Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking not feasible for pilot design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot randomised controlled trial with 2 parallel study arms.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 20, 2021
• Study Start: November 2, 2020
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)