Cannabis Suppositories and Mindful Compassion Online Groups for Sexual Functioning

September 27, 2024 updated by: Samantha Banbury, London Metropolitan University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, N7 8DB
        • School of Social Sciences and Professions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online mindful-compassion weekly for four weeks
Mindful compassion exercises
Behavioral: Mindful- compassion
Online mindful-compassion weekly for four weeks
Experimental: Cannabis suppositories and online mindful-compassion for vaginal pain
Behavioral: Mindful-compassion and cannabis suppositories
Cannabis suppositories and online mindful-compassion for vaginal pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 4 and 12 weeks
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.
0, 4 and 12 weeks
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.
0, 4 and 12 weeks
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
0, 4 and 12 weeks
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.
0, 4 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Metropolitan University

Investigators

  • Principal Investigator: Samantha Banbury, PhD, London Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

April 4, 2024

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • London Met Uni

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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