Gastro-intestinal PainNCT02222064
Pilot of Mindfulness Therapy for Inpatients With Gastro-intestinal Pain
A study testing Mindfulness in people with Gastro-intestinal Pain, run by University College, London at 1 site in United Kingdom.
Trial summary
Research questions/hypotheses 1. Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients reduce pain-related distress, improve quality of life, and increase confidence in pain self-management? 2. How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness methods? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-intestinal Pain
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years, pain experienced
- >3 months, proficiency in English
Who cannot join
- previous mindfulness experience
- severe cognitive impairment
- profound hearing difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of Mindfulness for Inpatients With Chronic Gastrointestinal Pain: Does it Reduce Pain Related Distress and Increase Confidence in Pain Self-management?
Research questions/hypotheses
- Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients reduce pain-related distress, improve quality of life, and increase confidence in pain self-management?
- How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness methods?
- Conditions
- Gastro-intestinal Pain
- Being tested
- Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Mindfulness is a psychological intervention based on increasing skills of non-judgemental awareness using meditations. In this study a self-directed 8 week course of mindfulness will be used involving self-help materials in the form of a book and 8 guided meditations on audio files.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | 8 week self-managed mindfulness based intervention Receives: Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain distress rating on 11 point numerical rating scale
A numerical rating scale scored from 0 to 10 which asks "how distressing is the pain on average in the last week with 0 being not distressing at all and 10 being extreme distress"
Measured: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
Secondary outcomes (7)
Hospital Anxiety and Depression Scale
Measured: At baseline, week 8
Pain Self Efficacy Questionnaire
a 10 item scale that attempts to capture a measure of individual's confidence in being active despite pain, rated on a numerical scale from 0 "not at all confident" to 6 "completely confident"
Measured: At baseline, week 8
Chronic Pain Acceptance Questionnaire
a 20 item measure included to provide a rating of acceptance of pain
Measured: At baseline, week 8
Five Facet Mindfulness Questionnaire
a 39 item questionnaire which has been developed from five mindfulness questionnaires using exploratory factor analysis
Measured: At baseline, week 8
Self-report record of using mindfulness exercises (frequency and duration)
Measured: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
Brief account of experience of pain and doing the mindfulness exercises
participants will be asked to write a brief (<1 page) account of their experience of their pain and of doing the mindfulness exercises over the preceding week
Measured: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
Change in pain intensity rating on 11 point numerical rating scale
A numerical rating scale scored from 0 to 10 which asks "how intense is the pain on average in the last week with 0 being no pain and 10 being extreme pain"
Measured: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-intestinal PainStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222064
- Sponsor's protocol ID
- 14/0190
- Status last verified
- May 2015
- First submitted
- 12 Aug 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Mindfulness for Inpatients With Chronic Gastrointestinal Pain: Does it Reduce Pain Related Distress and Increase Confidence in Pain Self-management?
- ClinicalTrials.gov ID
- NCT02222064
- Acronym / sponsor ID
- 14/0190
- Conditions
- Gastro-intestinal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research questions/hypotheses
- Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients reduce pain-related distress, improve quality of life, and increase confidence in pain self-management?
- How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness methods?
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness8 week self-managed mindfulness based intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years, pain experienced
- >3 months, proficiency in English
Key exclusion criteria (3 listed)
- previous mindfulness experience
- severe cognitive impairment
- profound hearing difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessMindfulness is a psychological intervention based on increasing skills of non-judgemental awareness using meditations. In this study a self-directed 8 week course of mindfulness will be used involving self-help materials in the form of a book and 8 guided meditations on audio files. | Behavioural | Mindfulness |
Primary outcome
Change in pain distress rating on 11 point numerical rating scale
Time frame: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
A numerical rating scale scored from 0 to 10 which asks "how distressing is the pain on average in the last week with 0 being not distressing at all and 10 being extreme distress"
7 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: At baseline, week 8
Pain Self Efficacy Questionnaire
Time frame: At baseline, week 8
Chronic Pain Acceptance Questionnaire
Time frame: At baseline, week 8
Five Facet Mindfulness Questionnaire
Time frame: At baseline, week 8
Self-report record of using mindfulness exercises (frequency and duration)
Time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
Brief account of experience of pain and doing the mindfulness exercises
Time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
Change in pain intensity rating on 11 point numerical rating scale
Time frame: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Gastro-intestinal Pain, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain distress rating on 11 point numerical rating scale (time frame: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.