The Use of Mindful Compassion and Cannabis Suppositories for Anal Pain Among Men Who Have Sex With Men

NCT ID: NCT06435650

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-04-24

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.

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.

Conditions

Pain;Sexual Intercourse;M

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindful-compassion group

Online mindful-compassion weekly for four weeks

Group Type: EXPERIMENTAL

Mindful-compassion

Intervention Type: BEHAVIORAL

Mindful-compassion

Mindful-compassion and Cannabis suppository

Participants were not prescribed cannabis as part of this study. Participants had been for at least one month before participating in the study. Participants used cannabis suppositories each time they engaged in anal intercourse (recipient). The average dose, based on participant reports, was approximately 500mg.

Online mindful-compassion weekly for four weeks

Group Type: EXPERIMENTAL

Cannabis suppositories and mindful-compassion for anal pain

Intervention Type: COMBINATION_PRODUCT

This is a combined intervention that includes mindful-compassion and cannabis suppositories for anal pain

Interventions

Cannabis suppositories and mindful-compassion for anal pain

This is a combined intervention that includes mindful-compassion and cannabis suppositories for anal pain

Intervention Type: COMBINATION_PRODUCT

Mindful-compassion

Mindful-compassion

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants were allocated to cannabis only, and cannabis adjunct groups would already be using cannabis suppositories.
• Must have engaged in anal sex within the last month
• Must be based in the United Kingdom
• Must have experienced anal sexual pain
• An absence of co-occurring difficulties
• 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

Exclusion Criteria

• Have not attempted anal intercourse in the last month
• Have co-occurring difficulties
• Aged below 18 years old
• Reading and writing English difficulties
• Not experiencing anal pain during sexual intercourse.
• Patient health screening score ranged between moderate to severe - 10-27
• Generalised anxiety screening score ranged between 10- 21.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

London Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Samantha Banbury

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samantha Banbury

Role: PRINCIPAL_INVESTIGATOR

London Metropolitan University

Locations

Samantha Banbury

London, , United Kingdom

Countries

United Kingdom

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Other Identifiers

London Metropolitan University

Identifier Type: -

Identifier Source: org_study_id