Mindfulness on Physical and Mental Condition in Older Adults With Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Mindfulness intervention

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Jaén, Spain
    • Municipal social services center "el boulevard"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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.
Experimental: Mindfulness intervention; 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.	Other: Mindfulness intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TUG test (Timed Up and Go test)	Is a simple test used to assess a person's mobility and physical function.	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.	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.	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.	Up to twelve weeks
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.	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.	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.	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.	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.	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 (+).	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.	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'.	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.	Up to twelve weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Is used to assess central fat distribution and degree of abdominal obesity	Up to twelve weeks
Hip circumference	It is measured at the level of the maximum prominence of the buttocks.	Up to twelve weeks
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	Up to twelve weeks

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: -University_of_Jaén

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No