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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04851626
Other study ID # 202935
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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