Chronic Hip PainCALMNCT02861170
Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability
A study testing Brief Mindfulness-Based Intervention in people with Chronic Hip Pain and Worries; Pain or Disability, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This study evaluates the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hip Pain, Worries; Pain or Disability, Quality of Life
- What is being tested?
- Brief Mindfulness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 26 Feb 2018to 31 Oct 2020
- 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
- Adult (age 18+) patients presenting at the Pre-Admission Unit (PAU) at the General campus of The Ottawa Hospital (TOH) for total hip arthroplasty (THA)
- History of pain for ≥3 months (chronic pain)
- Anxiety scores of ≥8 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- Ability to understand oral and written English or French
Who cannot join
- Refusal or inability to provide consent
- Severe depressive symptoms as indicated by score ≥ 20 on the Patient Health Questionnaire (PHQ-9) scale
- Prior mindfulness training experience
- Pre-planned same day discharge after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability Among Anxious Patients With Chronic Pain Undergoing Total Hip Arthroplasty - a Feasibility and Acceptability Pilot Randomized Controlled Trial
This study evaluates the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty.
All participants will receive an educational brochure and links to videos containing strategies for coping with pain and anxiety. The half of the participants who are allocated to the treatment arm will also receive a 10 minute mindfulness intervention called a body scan.
Read the detailed description
Psychological distress or anxiety is common in patients awaiting surgical procedures and can have impact on both physical and mental health, leading to significantly reduced quality of life. It has been associated with a slower and more complicated postoperative recovery and has been established as an independent predictor of pain and pain related outcomes after surgery.
Pharmacological interventions and provision of information about surgical processes are two ways that pre-operative anxiety is currently addressed. Mindfulness-based interventions have shown positive results in reducing psychological distress and improving pain related outcomes and may be a promising treatment avenue to evaluate in a surgical population.
With the goal of conducting a full-scale definitive trial to investigate the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty, this pilot study has been developed to demonstrate proof of concept, test/refine the intervention, recruitment, and data collection procedures, and test the intervention's acceptability in the peri-operative setting.
- Being tested
- Brief Mindfulness-Based Intervention
- Keywords
- Mindfulness, Chronic Pain, Chronic Hip Pain, Total Hip Arthroplasty, Disability, Quality of Life
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Mindfulness-Based InterventionBehavioural
Also called Body Scan, Guided Meditation
In addition to the educational materials that will be provided to all participants, the participants in the intervention group will also receive a 10-minute mindfulness-based intervention called a body scan. The body scan is a guided meditation exercise where participants are lead through focusing their attention on their body while maintaining awareness and acceptance of their sensations, emotions, and thoughts without trying to control or change them. The goal of the intervention is to increase mindfulness (i.e., moment-to-moment, non-judgmental and non-reactive awareness of sensations, emotions and thoughts), to provide self-regulation strategies, and to promote healthy and adaptive responses to stress.
| Study group | Role | What they receive |
|---|---|---|
| Brief Mindfulness-Based Intervention | Experimental | Participants in this arm will be provided with an educational brochure and links to videos containing strategies for coping with pain and anxiety as well as a 10-minute mindfulness-based intervention called a body scan at 3 different time-points (T1 - 1 week prior to surgery, T2 - within 4 hours before surgery, and T3 - approximately 24 hours after transfer from recovery to the orthopedic floor). Receives: Behavioral: Brief Mindfulness-Based Intervention |
| Education | No intervention | Participants in this arm will be provided with an educational brochure and links to videos containing strategies for coping with pain and anxiety. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at approximately 48 hours post-surgery.
The primary outcome will be the mean score of the Brief Pain Inventory (BPI) Interference Scale 48 hours post-surgery. The interference scale measures the degree to which pain interferes in the lives of participants in 7 domains: general activity, mood, walking ability, normal work, relations with other persons, sleep and enjoyment of life on a scale from 0 to 10. The higher the score, the greater the pain interferes with patient's activities.
Measured: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor
Secondary outcomes (4)
Change in pain intensity, as measured by the Brief Pain Inventory.
The Brief Pain Inventory (BPI) Pain Severity Scale measures the severity of pain one feels at worst, at least, on average, and at the time of questionnaire completion on a scale from 0 to 10. The higher the score, the greater the pain severity.
Measured: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a 13-item instrument which will evaluate the degree to which patients have negative self-statements and catastrophizing thoughts and ideations when in pain. The PCS uses a 5-point likert scale (0=not at all, 4=all the time) and consists of three subscales (rumination, magnification, helplessness).
Measured: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.
Mindfulness will be measured using the Short Form Five Facet Mindfulness Questionnaire (FFMQ-SF). The FFMQ-SF is a 24-item instrument measuring five aspects of mindfulness: Non-reactivity to inner experience, observing, describing, acting with awareness, and non-judging of experience. Participants are asked to use a 5-point Likert-type scale (1 = never or rarely true; 5 = very often or always true) to rate how true of them they believe each statement to be.
Measured: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
Change in quality of life, as measured by the EuroQOL-5D
The EuroQOL-5D (EQ-5D) is a simple-to-use, valid, and sensitive instrument measuring quality of life. It covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, or severe problems and participants use a tick box to select the statement that is most representative of their conditions. Participants are also asked to rate, using a visual analogue scale (0 to 100), their state of health.
Measured: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start26 Feb 2018
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Why it stopped: Study was a pilot and after recruitment started it was determined to not be feasible. Therefore study protocol will be reviewed to adjust for changes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hip PainStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Poulin, PhD C. Psych, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861170
- Sponsor's protocol ID
- 20160105-01H
- Acronym
- CALM
- Status last verified
- Nov 2020
- First submitted
- 23 Jun 2016
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability Among Anxious Patients With Chronic Pain Undergoing Total Hip Arthroplasty - a Feasibility and Acceptability Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02861170
- Acronym / sponsor ID
- CALM / 20160105-01H
- Keywords
- Mindfulness, Chronic Pain, Chronic Hip Pain, Total Hip Arthroplasty, Disability, Quality of Life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was a pilot and after recruitment started it was determined to not be feasible. Therefore study protocol will be reviewed to adjust for changes.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 10 Aug 2016 (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.
This study evaluates the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty.
All participants will receive an educational brochure and links to videos containing strategies for coping with pain and anxiety. The half of the participants who are allocated to the treatment arm will also receive a 10 minute mindfulness intervention called a body scan.
Detailed description
Psychological distress or anxiety is common in patients awaiting surgical procedures and can have impact on both physical and mental health, leading to significantly reduced quality of life. It has been associated with a slower and more complicated postoperative recovery and has been established as an independent predictor of pain and pain related outcomes after surgery.
Pharmacological interventions and provision of information about surgical processes are two ways that pre-operative anxiety is currently addressed. Mindfulness-based interventions have shown positive results in reducing psychological distress and improving pain related outcomes and may be a promising treatment avenue to evaluate in a surgical population.
With the goal of conducting a full-scale definitive trial to investigate the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty, this pilot study has been developed to demonstrate proof of concept, test/refine the intervention, recruitment, and data collection procedures, and test the intervention's acceptability in the peri-operative setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Mindfulness-Based Intervention | Experimental | Behavioral: Brief Mindfulness-Based InterventionParticipants in this arm will be provided with an educational brochure and links to videos containing strategies for coping with pain and anxiety as well as a 10-minute mindfulness-based intervention called a body scan at 3 different time-points (T1 - 1 week prior to surgery, T2 - within 4 hours before surgery, and T3 - approximately 24 hours after transfer from recovery to the orthopedic floor). |
| Education | No intervention | –Participants in this arm will be provided with an educational brochure and links to videos containing strategies for coping with pain and anxiety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (age 18+) patients presenting at the Pre-Admission Unit (PAU) at the General campus of The Ottawa Hospital (TOH) for total hip arthroplasty (THA)
- History of pain for ≥3 months (chronic pain)
- Anxiety scores of ≥8 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- Ability to understand oral and written English or French
Key exclusion criteria (4 listed)
- Refusal or inability to provide consent
- Severe depressive symptoms as indicated by score ≥ 20 on the Patient Health Questionnaire (PHQ-9) scale
- Prior mindfulness training experience
- Pre-planned same day discharge after surgery
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 |
|---|---|---|
| Brief Mindfulness-Based InterventionAlso: Body Scan, Guided MeditationIn addition to the educational materials that will be provided to all participants, the participants in the intervention group will also receive a 10-minute mindfulness-based intervention called a body scan. The body scan is a guided meditation exercise where participants are lead through focusing their attention on their body while maintaining awareness and acceptance of their sensations, emotions, and thoughts without trying to control or change them. The goal of the intervention is to increase mindfulness (i.e., moment-to-moment, non-judgmental and non-reactive awareness of sensations, emotions and thoughts), to provide self-regulation strategies, and to promote healthy and adaptive responses to stress. | Behavioural | Brief Mindfulness-Based Intervention |
Primary outcome
Change in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at approximately 48 hours post-surgery.
Time frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor
The primary outcome will be the mean score of the Brief Pain Inventory (BPI) Interference Scale 48 hours post-surgery. The interference scale measures the degree to which pain interferes in the lives of participants in 7 domains: general activity, mood, walking ability, normal work, relations with other persons, sleep and enjoyment of life on a scale from 0 to 10. The higher the score, the greater the pain interferes with patient's activities.
4 secondary outcomes
Change in pain intensity, as measured by the Brief Pain Inventory.
Time frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale
Time frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.
Time frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
Change in quality of life, as measured by the EuroQOL-5D
Time frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Patricia Poulin, PhD C. Psych principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Mindfulness-Based Intervention in people with Chronic Hip Pain and Worries; Pain or Disability, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 30 Nov 2020. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at approximately 48 hours post-surgery. (time frame: Within 4 hours before surgery and approximately 48 hours after transfer from recovery to the orthopedic floor). 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 30 Nov 2020.