Hypnotic Intervention for Women With Chronic Pelvic Pain
Primary Purpose
Chronic Pain, Pelvic Pain, Psychological
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Hypnotic intervention for persistent pelvic pain.
Control group persistent pelvic pain no intervention.
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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.
Sites / Locations
- University of South Australia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group - hypnotic intervention for persistent pelvic pain
Control group - waitlist control
Arm Description
Participants underwent education about persistent pain and a 7 week 7 recording online hypnotic intervention. Women with persistent pelvic pain.
Control group of women with persistent pelvic pain no intervention completed assessment and concluding measures but did not undergo hypnotic intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04851626
First Posted
April 8, 2021
Last Updated
April 14, 2021
Sponsor
University of South Australia
1. Study Identification
Unique Protocol Identification Number
NCT04851626
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
December 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pelvic Pain, Psychological, Hypnosis, Animal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot randomised controlled trial with 2 parallel study arms.
Masking
None (Open Label)
Masking Description
Masking not feasible for pilot design.
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group - hypnotic intervention for persistent pelvic pain
Arm Type
Experimental
Arm Description
Participants underwent education about persistent pain and a 7 week 7 recording online hypnotic intervention. Women with persistent pelvic pain.
Arm Title
Control group - waitlist control
Arm Type
Other
Arm Description
Control group of women with persistent pelvic pain no intervention completed assessment and concluding measures but did not undergo hypnotic intervention.
Intervention Type
Other
Intervention Name(s)
Hypnotic intervention for persistent pelvic pain.
Intervention Description
Education about persistent pelvic pain followed by 7 recordings of hypnosis intervention across 7 weeks accessed online through recordings.
Intervention Type
Other
Intervention Name(s)
Control group persistent pelvic pain no intervention.
Intervention Description
Control group no hypnotic intervention. Waitlist control.
Primary Outcome Measure Information:
Title
Feasibility of hypnotic intervention according to qualitative responses from women with persistent pelvic pain.
Description
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.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Impact on pain severity as indicated on a visual analogue scale (10 point).
Description
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.
Time Frame
7 weeks
Title
Impact on depression scores on the Patient Health Questionnaire nine-item scale
Description
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.
Time Frame
7 weeks
Title
Impact on anxiety scores on the Generalised Anxiety Disorder scale seven-item
Description
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.
Time Frame
7 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Brooks
Organizational Affiliation
University of South Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Permission was only sought for participants in this study.
Learn more about this trial
Hypnotic Intervention for Women With Chronic Pelvic Pain
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