Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607835
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None