Pain, Chronic Clinical Trial
Official title:
Does the Positive Mindfulness Program Increase Wellbeing in People With Chronic Pain?
This study aims to increase the well-being of individuals with chronic pain through a 4-week online positive mindfulness programme. Each module, lasting 4 days, will include a daily meditation and focus on a different aspect of positive psychology. This is a quantitative study. The independent variable is participation in the programme. The dependent variables are: wellbeing, mindfulness, pain severity, pain catastrophising and health quality of life. There will be one experimental group who participate in the programme as soon as they are recruited. There will be one control group who are put on a 'wait-list' to complete the programme after an 8 week wait. Pre and post measures will be taken. Participants are being recruited through NHS clinics in London and Oxford, including the Pain Management Centre at Oxford University Hospitals (Churchill site) and INPUT at St Thomas's Hospital (which are participant identification centres). Participants who hear about the study via other means including online or through word of mouth are also being accepted.
Practicing mindfulness has been demonstrated to have a variety of benefits such as reducing
stress, depression, anxiety, insomnia and pain symptoms. Positive psychology interventions
have been shown to increase well-being by enhancing resilience, improving health and having a
positive impact on levels of anxiety and depression.
The clinical guidance for treating individuals with chronic pain recommends reducing stress
and improving sleep and supporting patients to gain a greater sense of control over their
illness. Mindfulness has been shown to be effective in supporting patients with chronic pain
to achieve these outcomes.
This study is the first of its kind to combine aspects of positive psychology and mindfulness
to create an online programme specifically designed to enhance well-being. Previous
participants who have undertaken the Positive Mindfulness Programme have experienced reduced
depression and stress and an increase in well-being.
Participants will be recruited through the Pain Management Centre at Oxford University
Hospitals (Churchill site) and INPUT at St Thomas's Hospital. Patients with chronic pain will
be asked by their clinician if they would like to participate in the study. Clinicians will
then pass on (with consent) the contact details of interested potential participants to the
researcher. Patients can alternatively choose to get in touch with the researcher directly
themselves. Participants will undertake the online programme independently in any location
they choose to access the programme.
All participants will be sent an introductory email with a link to an online survey platform
where they will be asked to complete 5 pre-validated questionnaires. Within this invitation
email, the structure of the programme and daily commitment will be described. The
researcher's contact details will be provided should potential participants have any
questions regarding the 4-week programme. Participants will be asked to sign an online
consent form as part of the initial completion of the outcome measures, before they commence
the programme. Participants will logon to the online platform by creating a personalised,
anonymous username and password.
Once the participants have completed the baseline outcome measures, the experimental group
will be sent a link to the Positive Mindfulness Programme online course and they will be able
to begin the 4 week course. Participants will have controlled access to the website so will
be unable to start earlier than their slot.
Each week participants will watch a short video providing the theoretical basis for the
aspect of Positive Psychology and mindfulness they will be practicing. Each video will be
between 8 - 10 minutes long. At the end of the theory video, participants are asked to access
and download an audio file which provides them with their daily meditation practice for the
week. The audio files containing the daily meditation lasts 12-15 minutes. At the end of each
meditation, participants are invited to engage in a daily activity that has a positive
psychology focus. The topics covered include: self-awareness, positive emotions,
self-compassion, autonomy, self-efficacy, meaning, relations with others and engagement.
Participants are asked to practice the meditation daily. After practicing the meditation for
4 days, participants will log back into the survey site to complete the next week's material.
Participants continue this same process for the duration of the 4-weeks.
Upon completion of the 4 weeks of material, participants will be given a wrap-up session that
summarises each week of the programme. They will then be asked to complete the same
questionnaires that were administered at the beginning of the programme, thus providing
post-measures. One month after completion, participants will be contacted again to complete
the same series of questions.
Throughout the programme there will be a control group. This group will be asked to complete
the same measures at the same time points as the study group (immediately, at 4 weeks, at 8
weeks). However, these individuals will not participate in the weekly programme until 8 weeks
has passed. Once they have waited 8 weeks they will be offered the 4 week programme.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05452499 -
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
|
N/A | |
Recruiting |
NCT05037682 -
Pain and Opioid Management in Older Adults
|
N/A | |
Completed |
NCT04080037 -
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
|
N/A | |
Recruiting |
NCT05382962 -
iCanCope With Post-Operative Pain (iCanCope PostOp)
|
N/A | |
Recruiting |
NCT04285112 -
SPRINT: Signature for Pain Recovery IN Teens
|
||
Active, not recruiting |
NCT04850079 -
EHR Precision Drug Treatment in Neonates
|
||
Completed |
NCT03272139 -
Interscalene Block Versus Superior Trunk Block
|
Phase 4 | |
Completed |
NCT03271151 -
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT03886142 -
Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis
|
N/A | |
Recruiting |
NCT05761392 -
APP-based Precise Management System of Chronic Intractable Pain
|
N/A | |
Recruiting |
NCT05877157 -
Pain AND Opioids After Surgery
|
||
Completed |
NCT03947749 -
Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
|
||
Completed |
NCT03280017 -
Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain
|
Phase 4 | |
Recruiting |
NCT04874038 -
Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
|
Phase 3 | |
Completed |
NCT04280796 -
Changes in Affective Pain Processing in Human Volunteers
|
N/A | |
Withdrawn |
NCT05125978 -
Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain
|
Phase 2 | |
Not yet recruiting |
NCT04328805 -
Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.
|
Phase 4 | |
Completed |
NCT04976738 -
A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain
|
Phase 1/Phase 2 | |
Completed |
NCT04089618 -
Meditation Based Lifestyle Modification in Chronic Pain
|
N/A | |
Recruiting |
NCT05699837 -
Alpha Entrainment for Pain and Sleep (Extension)
|
N/A |