Clinical trial NCT06607835: Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Pain Disorders
Keywords: mindful-compassion
well-being
sexual self-efficacy
sexual functioning
cannabis suppositories
Lead sponsor: London Metropolitan University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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 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.

Primary outcomes:
measure: The Short Warwick -Edinburgh Mental Well-being Scale
timeFrame: 0, 4 and 12 weeks
measure: State Self-compassion Short Form
timeFrame: 0, 4 and 12 weeks
measure: The Female Sexual Function Index
timeFrame: 0, 4 and 12 weeks
measure: Sexual Self-Efficacy Scale for Female Sexual Functioning
timeFrame: 0, 4 and 12 weeks
measure: Brief Quality of Life Scale
timeFrame: 0, 4 and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: School of Social Sciences and Professions
Study officials:
affiliation: London Metropolitan University
name: Samantha Banbury, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Libman 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.