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Completed

NCT Number: NCT04851626

Hypnotic Intervention for Women With Chronic Pelvic Pain

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.

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Key information

Conditions

Chronic Pain Behavior Behavior, Animal Hypnosis, Animal Immobility Response, Tonic Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Psychological Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Australia

Adelaide, South Australia, 5000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control group persistent pelvic pain no intervention.

Other

Control group no hypnotic intervention. Waitlist control.

Primary outcomes

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

    Time frame: 7 weeks

    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 outcomes

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

    Time frame: 7 weeks

    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.

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

    Time frame: 7 weeks

    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.

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

    Time frame: 7 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of South Australia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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