Chronic PainNCT04851626
Hypnotic Intervention for Women With Chronic Pelvic Pain
A study testing Hypnotic intervention for persistent pelvic pain. in people with Chronic Pain and Pelvic Pain, run by University of South Australia at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Chronic Pain, Pelvic Pain, Psychological
- What is being tested?
- Hypnotic intervention for persistent pelvic pain.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Nov 2020to 21 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
University of South Australia
Adelaide, South Australia, 5000
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Pelvic Pain, Psychological, Hypnosis, Animal
- Being tested
- Hypnotic intervention for persistent pelvic pain., Control group persistent pelvic pain no intervention.
- Medical subject headings
- Chronic Pain, Pelvic Pain, Immobility Response, Tonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - hypnotic intervention for persistent pelvic pain | Experimental | Participants underwent education about persistent pain and a 7 week 7 recording online hypnotic intervention. Women with persistent pelvic pain. Receives: Other: Hypnotic intervention for persistent pelvic pain. |
| Control group - waitlist control | Other | Control group of women with persistent pelvic pain no intervention completed assessment and concluding measures but did not undergo hypnotic intervention. Receives: Other: Control group persistent pelvic pain no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start2 Nov 2020
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomised controlled trial with 2 parallel study arms.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiffany Brooks, University of South Australia
- Investigators
- Tiffany Brooks, Principal investigator, University of South Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851626
- Sponsor's protocol ID
- 202935
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Permission was only sought for participants in this study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnotic Intervention for Women With Chronic Pelvic Pain: a Pilot Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04851626
- Acronym / sponsor ID
- 202935
- Conditions
- Chronic Pain, Pelvic Pain, Psychological, Hypnosis, Animal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of South AustraliaUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomised controlled trial with 2 parallel study arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention group - hypnotic intervention for persistent pelvic pain | Experimental | Other: 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. |
| Control group - waitlist control | Other | Other: Control group persistent pelvic pain no intervention.Control group of women with persistent pelvic pain no intervention completed assessment and concluding measures but did not undergo hypnotic intervention. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Intervention group - hypnotic intervention for persistent pelvic pain |
| Control group persistent pelvic pain no intervention.Control group no hypnotic intervention. Waitlist control. | Other | Control group - waitlist control |
Primary outcome
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.
3 secondary outcomes
Impact on pain severity as indicated on a visual analogue scale (10 point).
Time frame: 7 weeks
Impact on depression scores on the Patient Health Questionnaire nine-item scale
Time frame: 7 weeks
Impact on anxiety scores on the Generalised Anxiety Disorder scale seven-item
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No. Permission was only sought for participants in this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Brooks principal investigator
University of South Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic intervention for persistent pelvic pain. in people with Chronic Pain and Pelvic Pain, run by University of South Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of hypnotic intervention according to qualitative responses from women with persistent pelvic pain. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.