Sexual Pain DisordersNCT06607835
Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning
A study testing Mindful- compassion and Mindful-compassion and cannabis suppositories in people with Sexual Pain Disorders, run by London Metropolitan University at 1 site in United Kingdom.
Trial summary
Research aim: To determine how an online mindful-compassion intervention adjunct with cannabis suppositories might reduce vaginal pain during sexual intimacy among women post-gynaecological cancer treatment. Outcomes are also hoped to increase sexual functioning, well-being, sexual self-efficacy and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Pain Disorders
- What is being tested?
- Mindful- compassion and Mindful-compassion and cannabis suppositories
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jul 2023to 4 Apr 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were allocated to cannabis only, and cannabis adjunct groups would already be using cannabis suppositories.
- Must have engaged in vaginal sex within the last month
- Must be at least 6 months post cancer treatment
- Must be based in the United Kingdom
- Must have experienced sexual pain
- An absence of co-occurring difficulties
Show all 10Show fewer
- Must be aged 18 years or older
- Must be able to read and write English.
- Patient health screening score must range between 0-9 mild
- Generalised anxiety disorder screening score must range between 0-9, mild
Who cannot join
- Have not attempted vaginal intercourse in the last month
- Have co-occurring difficulties
- Are still receiving cancer treatment or within 6 months of cancer treatment such as chemotherapy, surgery or radiation
- Aged below 18 years old
- Reading and writing English difficulties
- Not experiencing pain during vaginal sexual intercourse.
- Patient health screening score ranged between moderate to severe - 10-27
- Generalised anxiety screening score ranged between 10- 21.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Social Sciences and Professions
London, N7 8DB
About this study
Official title: A Preliminary Study Looking at the Use of Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning Among Women Post Gynaecological Cancer Treatment
Research aim: To determine how an online mindful-compassion intervention adjunct with cannabis suppositories might reduce vaginal pain during sexual intimacy among women post-gynaecological cancer treatment. Outcomes are also hoped to increase sexual functioning, well-being, sexual self-efficacy and quality of life.
Research intention: If the combined mindful compassion and cannabis suppository intervention reduces vaginal pain and supports sexual and general well-being, then this research would be repeated on a larger scale targeting psychosexual services.
Read more
A brief overview of the intervention:
Mindfulness has been anecdotally discussed in reducing symptoms of vaginal pain and increasing overall well-being. A novel approach to pain management includes medical cannabis, which can be cannabidiol, tetrahydrocannabinol or both. Vaginal suppositories do not create a euphoric high in the same way as oral use, including inhalation.
Quantitatively, randomisation will be based on whether participants use cannabis suppositories or not. This study does not randomise to cannabis groups owing to the legalities in the United Kingdom. Participants included eighty-three consenting participants. Of these, forty-one were using cannabis suppositories. The intervention was delivered for one month, and the follow-up was at twelve weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.
Read the detailed description
Research looking at mindfulness-based interventions or the use of medical cannabis to support sexual pain is limited, and often, sexual pain goes unreported, which might lead to compromised psychological well-being. Additionally, sexual problems associated with pain and related emotional suffering are frequently overlooked in patients with sexual pain, particularly among those who are post cancer treatments. This research aims to establish the effectiveness of an online mindful compassion intervention adjunct with cannabis suppositories to help minimise sexual pain and increase well-being. This research decided to deliver mindful compassion online because it would economically target a more comprehensive and diverse group. This preliminary study examined how a mindful compassion intervention combined with cannabis suppositories might help minimise sexual pain whilst improving sexual function, well-being, sexual self-efficacy and quality of life.
The main exercises included mindfulness, breathing, relaxation techniques, Mindfulness of the senses and body, and understanding the self. These exercises incorporated the three-model system of emotions, how to attend to the cognitive and physical patterns associated with painful sex, and towards acceptance and self-compassion with fewer symptoms. The mindful-compassion intervention included psychosexual education and vaginal pain, the three-model system of emotions and sexual pain, practising mindful compassion and graded practice and self-care, efficacy, and the relationship with anatomy.
Homework exercises, including education, training, modelling, and enablement, were encouraged. Feedback and support, along with discussing the educational components, training, modelling, and enablement, were addressed throughout this study.
The development of mindful compassion intervention has been based on a taxonomy of behavioural change techniques. This has been used because the taxonomy of behavioural change techniques has been rigorously tested to evidence the effectiveness in supporting interventions associated with change behaviour. The 93 behaviour change techniques are the active ingredients of behaviour change, and each intervention is likely to consist of more than one behaviour change technique and serve as having more than one function. The intervention in this study included twelve domains, of which twenty-three out of the 93 behaviour change techniques listed in the behavioural change technique taxonomy were identified. The selection of these domains used a triangulation process to ensure consistency in mapping the behaviour change techniques to the intervention.
Randomisation was based on whether participants were already using cannabis suppositories or not. Those who did use cannabis suppositories as part of their sex life would have been doing so for at least a month. There was a total of four groups, including a cannabis suppository-only group, a mindful-compassion-only group, a combined mindful compassion and cannabis suppository group and a care-as-usual group.
- Conditions
- Sexual Pain Disorders
- Being tested
- Mindful- compassion, Mindful-compassion and cannabis suppositories
- Keywords
- mindful-compassion, well-being, sexual self-efficacy, sexual functioning, cannabis suppositories
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful- compassionBehavioural
Online mindful-compassion weekly for four weeks
Mindful-compassion and cannabis suppositoriesBehavioural
Cannabis suppositories and online mindful-compassion for vaginal pain
| Study group | Role | What they receive |
|---|---|---|
| Online mindful-compassion weekly for four weeks | Experimental | Mindful compassion exercises Receives: Behavioral: Mindful- compassion |
| Cannabis suppositories and online mindful-compassion for vaginal pain | Experimental | Cannabis suppositories and online mindful-compassion for vaginal pain Receives: Behavioral: Mindful-compassion and cannabis suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Short Warwick -Edinburgh Mental Well-being Scale
This is a 7 item questionnaire with 5 response categories looking at functioning and feeling aspects of well-being. The response categories include 1=none of the time to 5=all of the time. Cronbach alpha for the questionnaire is 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing. The Cronbach alpha in this study was 0.85.
Measured: 0, 4 and 12 weeks
State Self-compassion Short Form
This is a 12 item measure with 5 response categories, 1 = almost never to 5 = almost always, with higher scores indicating higher levels of self-compassion. The questionnaire measures self-kindness versus. Self-judgement, common humanity versus isolation and mindfulness versus over-identification with painful thoughts and emotions. Reliability Cronbach alpha range between 0.68 and 0.78. The Cronbach alpha in this study was 0.73.
Measured: 0, 4 and 12 weeks
The Female Sexual Function Index
This is a 19 item measure of sexual pain, sexual desire, orgasm, lubrication, and sexual satisfaction with five response categories. The score range is 2.0 to 36.0 with 26.0 being the cut of for sexual dysfunction. Example questions include, Over the past 4 weeks, how often did you experience discomfort or pain during vaginal penetration? and Over the past 4 weeks, how would you rate your level of discomfort or pain during or following vaginal penetration? Cronbach alpha for this questionnaire is .820 and higher. For the present study, the Cronbach alpha was .750.
Measured: 0, 4 and 12 weeks
Sexual Self-Efficacy Scale for Female Sexual Functioning
This is a 37 item measure which embraces aspects of female sexuality such as arousal, desire, orgasm, pain and satisfaction. This is a 10 response category. The score ranges of 0 to10, 11 to 20, and 21 to 30 and represent low, moderate, and high self-efficacy levels. Example questions include anticipating, thinking about, having intercourse without fear or anxiety and Engaging in intercourse without pain or discomfort. The Cronbach alpha is .930 for this questionnaire. For the present study, the Cronbach alpha was .852
Measured: 0, 4 and 12 weeks
Brief Quality of Life Scale
An 8 item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity. This scale is scored by transforming the individual item scores from a 1 to 5 scale to a 0 to 100 scale. Example responses include how I view my life as necessary for my quality of life, and I am satisfied with my friends and friendship: The Cronbach alpha is .760 for this questionnaire. For the present study, the Cronbach alpha was .789.
Measured: 0, 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start2 Jul 2023
- Primary completion1 Oct 2023
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sexual Pain DisordersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study phase is not applicable as whilst cannabis suppositories are part of this research study, participants are not randomised into cannabis groups. Participants would already be using cannabis suppositories for at least one month and are used as part of the individuals sexual intimacy. Randomisation was based on whether participants were using cannabis suppositories and consisted of one of four groups, including a cannabis suppository-only group, mindful- compassion only group, a combined mindful-compassion and cannabis suppository group and a care-as-usual group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Banbury, London Metropolitan University
- Investigators
- Samantha Banbury, PhD, Principal investigator, London Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607835
- Sponsor's protocol ID
- London Met Uni
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brotto LA, Yule M, Breckon E. Psychological interventions for the sexual sequelae of cancer: a review of the literature. J Cancer Surviv. 2010 Dec;4(4):346-60. doi: 10.1007/s11764-010-0132-z. Epub 2010 Jul 3.
PubMed 20602188Brotto LA, Erskine Y, Carey M, Ehlen T, Finlayson S, Heywood M, Kwon J, McAlpine J, Stuart G, Thomson S, Miller D. A brief mindfulness-based cognitive behavioral intervention improves sexual functioning versus wait-list control in women treated for gynecologic cancer. Gynecol Oncol. 2012 May;125(2):320-5. doi: 10.1016/j.ygyno.2012.01.035. Epub 2012 Jan 28.
PubMed 22293042Brotto LA, Stephenson KR, Zippan N. Feasibility of an Online Mindfulness-Based Intervention for Women with Sexual Interest/Arousal Disorder. Mindfulness (N Y). 2022;13(3):647-659. doi: 10.1007/s12671-021-01820-4. Epub 2022 Jan 4.
PubMed 35035598Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
PubMed 18042300Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
PubMed 21584907Libman E, Rothenberg I, Fichten CS, Amsel R. The SSES-E: a measure of sexual self-efficacy in erectile functioning. J Sex Marital Ther. 1985 Winter;11(4):233-47. doi: 10.1080/00926238508405450.
PubMed 4078907
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study Looking at the Use of Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning Among Women Post Gynaecological Cancer Treatment
- ClinicalTrials.gov ID
- NCT06607835
- Acronym / sponsor ID
- London Met Uni
- Conditions
- Sexual Pain Disorders
- Keywords
- mindful-compassion, well-being, sexual self-efficacy, sexual functioning, cannabis suppositories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- London Metropolitan UniversityUniversity, hospital or other
- Study start
- 2 Jul 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 23 Sep 2024 (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.
Research aim: To determine how an online mindful-compassion intervention adjunct with cannabis suppositories might reduce vaginal pain during sexual intimacy among women post-gynaecological cancer treatment. Outcomes are also hoped to increase sexual functioning, well-being, sexual self-efficacy and quality of life.
Research intention: If the combined mindful compassion and cannabis suppository intervention reduces vaginal pain and supports sexual and general well-being, then this research would be repeated on a larger scale targeting psychosexual services.
A brief overview of the intervention:
Mindfulness has been anecdotally discussed in reducing symptoms of vaginal pain and increasing overall well-being. A novel approach to pain management includes medical cannabis, which can be cannabidiol, tetrahydrocannabinol or both. Vaginal suppositories do not create a euphoric high in the same way as oral use, including inhalation.
Quantitatively, randomisation will be based on whether participants use cannabis suppositories or not. This study does not randomise to cannabis groups owing to the legalities in the United Kingdom. Participants included eighty-three consenting participants. Of these, forty-one were using cannabis suppositories. The intervention was delivered for one month, and the follow-up was at twelve weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.
Detailed description
Research looking at mindfulness-based interventions or the use of medical cannabis to support sexual pain is limited, and often, sexual pain goes unreported, which might lead to compromised psychological well-being. Additionally, sexual problems associated with pain and related emotional suffering are frequently overlooked in patients with sexual pain, particularly among those who are post cancer treatments. This research aims to establish the effectiveness of an online mindful compassion intervention adjunct with cannabis suppositories to help minimise sexual pain and increase well-being. This research decided to deliver mindful compassion online because it would economically target a more comprehensive and diverse group. This preliminary study examined how a mindful compassion intervention combined with cannabis suppositories might help minimise sexual pain whilst improving sexual function, well-being, sexual self-efficacy and quality of life.
The main exercises included mindfulness, breathing, relaxation techniques, Mindfulness of the senses and body, and understanding the self. These exercises incorporated the three-model system of emotions, how to attend to the cognitive and physical patterns associated with painful sex, and towards acceptance and self-compassion with fewer symptoms. The mindful-compassion intervention included psychosexual education and vaginal pain, the three-model system of emotions and sexual pain, practising mindful compassion and graded practice and self-care, efficacy, and the relationship with anatomy.
Homework exercises, including education, training, modelling, and enablement, were encouraged. Feedback and support, along with discussing the educational components, training, modelling, and enablement, were addressed throughout this study.
The development of mindful compassion intervention has been based on a taxonomy of behavioural change techniques. This has been used because the taxonomy of behavioural change techniques has been rigorously tested to evidence the effectiveness in supporting interventions associated with change behaviour. The 93 behaviour change techniques are the active ingredients of behaviour change, and each intervention is likely to consist of more than one behaviour change technique and serve as having more than one function. The intervention in this study included twelve domains, of which twenty-three out of the 93 behaviour change techniques listed in the behavioural change technique taxonomy were identified. The selection of these domains used a triangulation process to ensure consistency in mapping the behaviour change techniques to the intervention.
Randomisation was based on whether participants were already using cannabis suppositories or not. Those who did use cannabis suppositories as part of their sex life would have been doing so for at least a month. There was a total of four groups, including a cannabis suppository-only group, a mindful-compassion-only group, a combined mindful compassion and cannabis suppository group and a care-as-usual group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study phase is not applicable as whilst cannabis suppositories are part of this research study, participants are not randomised into cannabis groups. Participants would already be using cannabis suppositories for at least one month and are used as part of the individuals sexual intimacy. Randomisation was based on whether participants were using cannabis suppositories and consisted of one of four groups, including a cannabis suppository-only group, mindful- compassion only group, a combined mindful-compassion and cannabis suppository group and a care-as-usual group
| Arm | Type | Receives |
|---|---|---|
| Online mindful-compassion weekly for four weeks | Experimental | Behavioral: Mindful- compassionMindful compassion exercises |
| Cannabis suppositories and online mindful-compassion for vaginal pain | Experimental | Behavioral: Mindful-compassion and cannabis suppositoriesCannabis suppositories and online mindful-compassion for vaginal pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants were allocated to cannabis only, and cannabis adjunct groups would already be using cannabis suppositories.
- Must have engaged in vaginal sex within the last month
- Must be at least 6 months post cancer treatment
- Must be based in the United Kingdom
- Must have experienced sexual pain
Key exclusion criteria (8 listed)
- Have not attempted vaginal intercourse in the last month
- Have co-occurring difficulties
- Are still receiving cancer treatment or within 6 months of cancer treatment such as chemotherapy, surgery or radiation
- Aged below 18 years old
- Reading and writing English difficulties
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 |
|---|---|---|
| Mindful- compassionOnline mindful-compassion weekly for four weeks | Behavioural | Online mindful-compassion weekly for four weeks |
| Mindful-compassion and cannabis suppositoriesCannabis suppositories and online mindful-compassion for vaginal pain | Behavioural | Cannabis suppositories and online mindful-compassion for vaginal pain |
Primary outcome
The Short Warwick -Edinburgh Mental Well-being Scale
Time frame: 0, 4 and 12 weeks
This is a 7 item questionnaire with 5 response categories looking at functioning and feeling aspects of well-being. The response categories include 1=none of the time to 5=all of the time. Cronbach alpha for the questionnaire is 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing. The Cronbach alpha in this study was 0.85.
State Self-compassion Short Form
Time frame: 0, 4 and 12 weeks
This is a 12 item measure with 5 response categories, 1 = almost never to 5 = almost always, with higher scores indicating higher levels of self-compassion. The questionnaire measures self-kindness versus. Self-judgement, common humanity versus isolation and mindfulness versus over-identification with painful thoughts and emotions. Reliability Cronbach alpha range between 0.68 and 0.78. The Cronbach alpha in this study was 0.73.
The Female Sexual Function Index
Time frame: 0, 4 and 12 weeks
This is a 19 item measure of sexual pain, sexual desire, orgasm, lubrication, and sexual satisfaction with five response categories. The score range is 2.0 to 36.0 with 26.0 being the cut of for sexual dysfunction. Example questions include, Over the past 4 weeks, how often did you experience discomfort or pain during vaginal penetration? and Over the past 4 weeks, how would you rate your level of discomfort or pain during or following vaginal penetration? Cronbach alpha for this questionnaire is .820 and higher. For the present study, the Cronbach alpha was .750.
Sexual Self-Efficacy Scale for Female Sexual Functioning
Time frame: 0, 4 and 12 weeks
This is a 37 item measure which embraces aspects of female sexuality such as arousal, desire, orgasm, pain and satisfaction. This is a 10 response category. The score ranges of 0 to10, 11 to 20, and 21 to 30 and represent low, moderate, and high self-efficacy levels. Example questions include anticipating, thinking about, having intercourse without fear or anxiety and Engaging in intercourse without pain or discomfort. The Cronbach alpha is .930 for this questionnaire. For the present study, the Cronbach alpha was .852
Brief Quality of Life Scale
Time frame: 0, 4 and 12 weeks
An 8 item questionnaire with five response categories looking at satisfaction with self, friends, family and creativity. This scale is scored by transforming the individual item scores from a 1 to 5 scale to a 0 to 100 scale. Example responses include how I view my life as necessary for my quality of life, and I am satisfied with my friends and friendship: The Cronbach alpha is .760 for this questionnaire. For the present study, the Cronbach alpha was .789.
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 1 Oct 2024.
- Results publication: PubMed 20602188Brotto LA, Yule M, Breckon E. Psychological interventions for the sexual sequelae of cancer: a review of the literature. J Cancer Surviv. 2010 Dec;4(4):346-60. doi: 10.1007/s11764-010-0132-z. Epub 2010 Jul 3.
- Results publication: PubMed 22293042Brotto LA, Erskine Y, Carey M, Ehlen T, Finlayson S, Heywood M, Kwon J, McAlpine J, Stuart G, Thomson S, Miller D. A brief mindfulness-based cognitive behavioral intervention improves sexual functioning versus wait-list control in women treated for gynecologic cancer. Gynecol Oncol. 2012 May;125(2):320-5. doi: 10.1016/j.ygyno.2012.01.035. Epub 2012 Jan 28.
- Results publication: PubMed 35035598Brotto LA, Stephenson KR, Zippan N. Feasibility of an Online Mindfulness-Based Intervention for Women with Sexual Interest/Arousal Disorder. Mindfulness (N Y). 2022;13(3):647-659. doi: 10.1007/s12671-021-01820-4. Epub 2022 Jan 4.
- Results publication: PubMed 18042300Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
- Results publication: PubMed 21584907Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Results publication: PubMed 4078907Libman E, Rothenberg I, Fichten CS, Amsel R. The SSES-E: a measure of sexual self-efficacy in erectile functioning. J Sex Marital Ther. 1985 Winter;11(4):233-47. doi: 10.1080/00926238508405450.
- Individual participant dataSharing planned: No
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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.
Samantha Banbury, PhD principal investigator
London Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful- compassion and Mindful-compassion and cannabis suppositories in people with Sexual Pain Disorders, run by London Metropolitan University at 1 site in United Kingdom.
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 10 inclusion and 8 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 1 Oct 2024. 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 United Kingdom. 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?
The Short Warwick -Edinburgh Mental Well-being Scale (time frame: 0, 4 and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06607835, which also lists 6 linked publications.
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 1 Oct 2024.