Hypnotic Intervention for Women With Chronic Pelvic Pain

Hypnotic Intervention for Women With Chronic Pelvic Pain: a Pilot Randomised Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Pelvic Pain; Psychological; Hypnosis, Animal
• Intervention / Treatment: Other: Hypnotic intervention for persistent pelvic pain.; Other: Control group persistent pelvic pain no intervention.

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • University of South Australia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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: 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: Control group persistent pelvic pain no intervention.; Control group no hypnotic intervention. Waitlist control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on pain severity as indicated on a visual analogue scale (10 point).	Whether hypnotic intervention lead to significant differences in pain severity intervention group in comparison to controls. Pain severity was measured on a 10-point visual analogue scale. In terms of scores, 0 indicated no pain and 10 indicated the most severe pain possible. Higher scores indicated more pain severity. Minimum score is 0 and maximum potential score is 10.	7 weeks
Impact on depression scores on the Patient Health Questionnaire nine-item scale	Whether hypnotic intervention lead to significant differences in depression scores on the Patient Health Questionnaire nine-item scale in intervention group in comparison to controls.The scale has nine questions about depression symptoms, that are each scored on a scale of 0 (not at all) to 3 (nearly every day). The minimum score was 0 and the maximum score is 27, with higher scores meaning more depression symptoms present.	7 weeks
Impact on anxiety scores on the Generalised Anxiety Disorder scale seven-item	Whether hypnotic intervention lead to significant differences in anxiety score on the Generalised Anxiety Disorder 7-item scale for the intervention group in comparison to controls. The Generalised Anxiety Disorder seven-item has seven questions about anxiety symptoms scored from 0 (not at all) to 4 (every day). The minimum score in 0 and maximum score is 28, with higher scores indicating more anxiety.	7 weeks

Collaborators and Investigators

• Sponsor: University of South Australia
• Investigators: Principal Investigator: Tiffany Brooks, University of South Australia

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Pelvic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: 202935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Permission was only sought for participants in this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No