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

NCT06213181 | Completed

• 1 other identifier: -University_of_Jaén
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (3)

• BMI (Body Mass Index)

  Up to twelve weeks

• Waist circumference

  Up to twelve weeks

• Hip circumference

  Up to twelve weeks

Study Arms (2)

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.

Other: Mindfulness intervention

Interventions

Mindfulness intervention OTHER

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.

Mindfulness intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Municipal social services center "el boulevard"

Jaén, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: To assign participants to the control and intervention groups, random sampling will be carried out using sealed and completely opaque envelopes. It will be carried out by a researcher who will not intervene in the different phases of the intervention: neither in the initial phase nor in the subsequent evaluation phase. Therefore, the rest of the researchers will not know to which group each participant who has been included in the study has been assigned.The assignment will be communicated using sealed and totally opaque envelopes. The analysis of the results will be carried out by a researcher unrelated to the group assignment and the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: February 19, 2024
• Primary Completion: February 26, 2024
• Study Completion: April 19, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

ES (1)