Hypnotic Intervention for Women With Chronic Pelvic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04851626
• Other study ID #: 202935
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: December 21, 2020

Study information

• Verified date: April 2021
• Source: University of South Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Hypnosis, Animal
• Pelvic Pain
• Psychological

Intervention

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.
• Control group persistent pelvic pain no intervention.
Control group no hypnotic intervention. Waitlist control.

Locations

Country	Name	City	State
Australia	University of South Australia	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
University of South Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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