Pilot of Mindfulness Therapy for Inpatients With Gastro-intestinal Pain

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

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?

Study Overview

• Status: Completed
• Conditions: Gastro-intestinal Pain
• Intervention / Treatment: Behavioral: Mindfulness

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2BU
    • University College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >18 years, pain experienced
• >3 months, proficiency in English

Exclusion Criteria:

• previous mindfulness experience
• severe cognitive impairment
• profound hearing difficulties

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; 8 week self-managed mindfulness based intervention	Behavioral: Mindfulness; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale		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"	At baseline, week 8
Chronic Pain Acceptance Questionnaire	a 20 item measure included to provide a rating of acceptance of pain	At baseline, week 8
Five Facet Mindfulness Questionnaire	a 39 item questionnaire which has been developed from five mindfulness questionnaires using exploratory factor analysis	At baseline, week 8
Self-report record of using mindfulness exercises (frequency and duration)		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	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"	Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (Estimate): August 21, 2014

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 14/0190