Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435650
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2024-05-21
Brief Title:
The Use of Mindful Compassion and Cannabis Suppositories for Anal Pain Among Men Who Have Sex With Men
Sponsor:
London Metropolitan University
Organization:
London Metropolitan University
Study Overview
Official Title:
The Use of Mindful Compassion and Cannabis Suppositories for Anal Pain Among Men Who Have Sex With Men
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research aim To determine how an online mindful-compassion intervention adjunct with cannabis suppositories might reduce anal pain during sexual intimacy among men who have sex with men Outcomes are also hoped to increase sexual functioning well-being and sexual self-efficacy
Research intention If the combined mindful compassion and cannabis suppository intervention reduces anal 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
Anal pain is pain experienced in the anus during anal penetration with a penis or other objects Most research on anal pain during sexual intimacy has centred on men who have sex with men Mindfulness has been anecdotally discussed in reducing symptoms of anal pain in men who have sex with men A novel approach to pain management includes medical cannabis which can be cannabidiol tetrahydrocannabinol or both Anal 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 fifty-two consenting participants Of these thirty-three 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
Research intention If the combined mindful compassion and cannabis suppository intervention reduces anal 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
Anal pain is pain experienced in the anus during anal penetration with a penis or other objects Most research on anal pain during sexual intimacy has centred on men who have sex with men Mindfulness has been anecdotally discussed in reducing symptoms of anal pain in men who have sex with men A novel approach to pain management includes medical cannabis which can be cannabidiol tetrahydrocannabinol or both Anal 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 fifty-two consenting participants Of these thirty-three 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 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 and sexual self-efficacy
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 anal 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
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 anal 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None