Chronic PainNCT06213181
Mindfulness on Physical and Mental Condition in Older Adults With Chronic Pain
A study testing Mindfulness intervention in people with Chronic Pain, run by University of Jaén at 1 site in Spain.
Trial summary
This research corresponds to an experimental study, a randomized controlled clinical trial in people over 65 years of age, distributed into two groups: the experimental group will receive a program that will consist of an eight-week mindfulness-based intervention; and the control group that will only receive general… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Mindfulness intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2024to 19 Apr 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The study participants are men and women over 65 years of age residing in the city of Jaén (Spain).
- People with pain with more than 3 months of evolution.
- Participants must have completed the informed consent.
Who cannot join
- That they do not voluntarily accept to participate in the study and that they are able to understand the instructions and follow the instructions of the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Intervention Based on Mindfulness on the Physical and Mental Condition in People Over 65 Years of Age With Chronic Musculoskeletal Pain
This research corresponds to an experimental study, a randomized controlled clinical trial in people over 65 years of age, distributed into two groups: the experimental group will receive a program that will consist of an eight-week mindfulness-based intervention; and the control group that will only receive general recommendations about the benefits of physical exercise. Measurements will be carried out at the beginning of the intervention and immediately after its completion.
- Conditions
- Chronic Pain
- Being tested
- Mindfulness intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionOther
It consists of 8 weekly sessions with a duration of 2 hours each. A variety of mindfulness practices including mindful movement will be introduced in all sessions. Participants will approach meditation as something natural and everyday, with the possibility of directing attention in all the moments and activities of daily life. Body scanning practices and conscious breathing will also be included. We will work in the group, with reflections and readings, as well as carrying out meditation and mindfulness practices, during the week, so that they can be carried out in the daily life of each participant. The intervention based on mindfulness will focus on the areas of well-being and personal skills such as attention, communication, emotional regulation and decision making.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants assigned to this group will receive general advice about the positive effects of regular physical activity. They will be given a guide of physical exercise recommendations, according to the World Health Organization for people over 65 years of age. |
| Mindfulness intervention | Experimental | Participants assigned to this group will receive a mindfulness-based intervention for eight weeks with a weekly session lasting two hours per session. It is an experimental and interactive program that includes conscious movements, meditation, practical activities on attention in the present moment and the search for strategies to face complex situations from the collective and individual level. Participants will carry out daily practices at home during the week with the resources shared in each session. Receives: Other: Mindfulness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-12 (reduced version of The Health Survey Short Form-36)
Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.
Measured: Up to twelve weeks
Numeric Rating Scale (NRS)
Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: Up to twelve weeks
FSS (Fatigue Severity Scale)
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living. The test is made up of 9 items with 7 response possibilities, so that 1 and 7 correspond to the minimum and maximum severity respectively. The total score corresponds to the sum of all the items with a total score range that goes from 9 to 63.
Measured: Up to twelve weeks
PSQI (Pittsburgh Sleep Quality Index)
A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep. It contains a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates severe difficulty, within their respective area. The scores of the seven areas are finally added to give an overall score, which ranges between 0 and 21 points. "0" indicates ease of sleeping and "21" severe difficulty in all areas.
Measured: Up to twelve weeks
PSS (Perceived Stress Scale)
It consists of 14 items with a five-point scale response format (0 = never, 1 = almost never, 2 = occasionally, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10 and 13 (in the following sense: 0=4, 1=3, 2=2, 3=1 and 4 =0) and then adding the 14 items. The direct score obtained indicates that a higher score corresponds to a higher level of perceived stress.
Measured: Up to twelve weeks
Chair stand test
Evaluate the strength of the lower body. The total number of times you "get up and sit down" in the chair for 30" is counted. If at the end of the exercise the participant has completed half or more of the movement (standing up and sitting down), it will be counted as complete.
Measured: Up to twelve weeks
TUG test (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function.
Measured: Up to twelve weeks
Tinetti scale
It is used to determine early the risk of falling in an elderly person during the year following its application. The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.
Measured: Up to twelve weeks
HADS (The Hospital Anxiety And Depression)
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients. The test contains 14 items with a score from 0 to 3, of which 7 items refer to depression and 7 to anxiety. The total score is 0-21, where a higher score corresponds to worse symptoms of anxiety and depression.
Measured: Up to twelve weeks
Arm curl test
Evaluate upper body strength. The total number of times the arm is "flexed and extended" during 30" is counted. If at the end of the exercise the participant has completed half or more of the movement (flexion and extension of the arm), it will be counted as complete.
Measured: Up to twelve weeks
Back scratch test
Evaluate the flexibility of the upper body (mainly the shoulders). The participant will make two attempts with the best side before starting the test and it will be noted on the record sheet by putting a circle in the best of them.
Measured: Up to twelve weeks
Chair-sit and reach-test
Evaluate the flexibility of the lower body (mainly biceps femoris). The participant will perform two attempts with the preferred leg and the examiner will record the two results by circling the best of them on the recording sheet. The distance is measured from the tips of the fingers of the hands to the top of the shoe. Touching the toe of the shoe will score "Zero". If the fingers of the hands do not reach the foot, the distance will be measured in negative values (-). If the fingers of the hands exceed the foot, the distance is recorded in positive values (+).
Measured: Up to twelve weeks
Brief Pain Questionnaire (CBD)
It is a multidimensional pain assessment instrument that provides information on the intensity of pain and its interference with patients' daily activities. Also assess the description, location of the pain and the level of relief provided by the treatment.
Measured: Up to twelve weeks
Secondary outcomes (3)
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat
Measured: Up to twelve weeks
Waist circumference
Is used to assess central fat distribution and degree of abdominal obesity
Measured: Up to twelve weeks
Hip circumference
It is measured at the level of the maximum prominence of the buttocks.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start19 Feb 2024
- Primary completion26 Feb 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213181
- Sponsor's protocol ID
- -University_of_Jaén
- Status last verified
- Jun 2024
- First submitted
- 9 Jan 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Intervention Based on Mindfulness on the Physical and Mental Condition in People Over 65 Years of Age With Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT06213181
- Acronym / sponsor ID
- -University_of_Jaén
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- 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 research corresponds to an experimental study, a randomized controlled clinical trial in people over 65 years of age, distributed into two groups: the experimental group will receive a program that will consist of an eight-week mindfulness-based intervention; and the control group that will only receive general recommendations about the benefits of physical exercise. Measurements will be carried out at the beginning of the intervention and immediately after its completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants assigned to this group will receive general advice about the positive effects of regular physical activity. They will be given a guide of physical exercise recommendations, according to the World Health Organization for people over 65 years of age. |
| Mindfulness intervention | Experimental | Other: Mindfulness interventionParticipants assigned to this group will receive a mindfulness-based intervention for eight weeks with a weekly session lasting two hours per session. It is an experimental and interactive program that includes conscious movements, meditation, practical activities on attention in the present moment and the search for strategies to face complex situations from the collective and individual level. Participants will carry out daily practices at home during the week with the resources shared in each session. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- The study participants are men and women over 65 years of age residing in the city of Jaén (Spain).
- People with pain with more than 3 months of evolution.
- Participants must have completed the informed consent.
Key exclusion criteria (1 listed)
- That they do not voluntarily accept to participate in the study and that they are able to understand the instructions and follow the instructions of the intervention.
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 |
|---|---|---|
| Mindfulness interventionIt consists of 8 weekly sessions with a duration of 2 hours each. A variety of mindfulness practices including mindful movement will be introduced in all sessions. Participants will approach meditation as something natural and everyday, with the possibility of directing attention in all the moments and activities of daily life. Body scanning practices and conscious breathing will also be included. We will work in the group, with reflections and readings, as well as carrying out meditation and mindfulness practices, during the week, so that they can be carried out in the daily life of each participant. The intervention based on mindfulness will focus on the areas of well-being and personal skills such as attention, communication, emotional regulation and decision making. | Other | Mindfulness intervention |
Primary outcome
SF-12 (reduced version of The Health Survey Short Form-36)
Time frame: Up to twelve weeks
Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.
Numeric Rating Scale (NRS)
Time frame: Up to twelve weeks
Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
FSS (Fatigue Severity Scale)
Time frame: Up to twelve weeks
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living. The test is made up of 9 items with 7 response possibilities, so that 1 and 7 correspond to the minimum and maximum severity respectively. The total score corresponds to the sum of all the items with a total score range that goes from 9 to 63.
PSQI (Pittsburgh Sleep Quality Index)
Time frame: Up to twelve weeks
A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep. It contains a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates severe difficulty, within their respective area. The scores of the seven areas are finally added to give an overall score, which ranges between 0 and 21 points. "0" indicates ease of sleeping and "21" severe difficulty in all areas.
PSS (Perceived Stress Scale)
Time frame: Up to twelve weeks
It consists of 14 items with a five-point scale response format (0 = never, 1 = almost never, 2 = occasionally, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10 and 13 (in the following sense: 0=4, 1=3, 2=2, 3=1 and 4 =0) and then adding the 14 items. The direct score obtained indicates that a higher score corresponds to a higher level of perceived stress.
Chair stand test
Time frame: Up to twelve weeks
Evaluate the strength of the lower body. The total number of times you "get up and sit down" in the chair for 30" is counted. If at the end of the exercise the participant has completed half or more of the movement (standing up and sitting down), it will be counted as complete.
TUG test (Timed Up and Go test)
Time frame: Up to twelve weeks
Is a simple test used to assess a person's mobility and physical function.
Tinetti scale
Time frame: Up to twelve weeks
It is used to determine early the risk of falling in an elderly person during the year following its application. The result of both sections will be added, so that a score of less than 19 points will imply a high risk of falls, a score of 19 to 24 will reflect medium risk of falls and a score of 25 to 28 will indicate low risk of falls.
HADS (The Hospital Anxiety And Depression)
Time frame: Up to twelve weeks
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients. The test contains 14 items with a score from 0 to 3, of which 7 items refer to depression and 7 to anxiety. The total score is 0-21, where a higher score corresponds to worse symptoms of anxiety and depression.
Arm curl test
Time frame: Up to twelve weeks
Evaluate upper body strength. The total number of times the arm is "flexed and extended" during 30" is counted. If at the end of the exercise the participant has completed half or more of the movement (flexion and extension of the arm), it will be counted as complete.
Back scratch test
Time frame: Up to twelve weeks
Evaluate the flexibility of the upper body (mainly the shoulders). The participant will make two attempts with the best side before starting the test and it will be noted on the record sheet by putting a circle in the best of them.
Chair-sit and reach-test
Time frame: Up to twelve weeks
Evaluate the flexibility of the lower body (mainly biceps femoris). The participant will perform two attempts with the preferred leg and the examiner will record the two results by circling the best of them on the recording sheet. The distance is measured from the tips of the fingers of the hands to the top of the shoe. Touching the toe of the shoe will score "Zero". If the fingers of the hands do not reach the foot, the distance will be measured in negative values (-). If the fingers of the hands exceed the foot, the distance is recorded in positive values (+).
Brief Pain Questionnaire (CBD)
Time frame: Up to twelve weeks
It is a multidimensional pain assessment instrument that provides information on the intensity of pain and its interference with patients' daily activities. Also assess the description, location of the pain and the level of relief provided by the treatment.
3 secondary outcomes
BMI (Body Mass Index)
Time frame: Up to twelve weeks
Waist circumference
Time frame: Up to twelve weeks
Hip circumference
Time frame: Up to twelve weeks
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 13 Jun 2024.
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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 intervention in people with Chronic Pain, run by University of Jaén at 1 site in Spain.
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 3 inclusion and 1 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 13 Jun 2024. 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 Spain. 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?
SF-12 (reduced version of The Health Survey Short Form-36) (time frame: Up to twelve weeks). The study lists 13 primary outcomes in all. 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 13 Jun 2024.