About this trial

A randomized controlled clinical trial will be conducted, involving a psychoeducational activity as the intervention. There will be a control group of patients with non-cancer chronic pain who will continue their usual treatment.

The trial will end after 3 months. Pain, well-being, medication management, mood, self-esteem, and quality of life will be compared just before starting the workshop with the status at the end of the workshop (one month later) to assess the immediate effect, and three months later to evaluate the medium-term effect. These measurements will be taken in both the control and intervention groups.

Additionally, for the intervention group, a follow-up will be conducted six months after the workshop ends to assess the long-term effect duration.

This study does not allow blinding of patients or professionals conducting the intervention, but the person analyzing the data to compare the effect produced in the control and intervention groups will be blinded. Therefore, it is an observer-blind evaluation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged 18 years or older,

Residing in the areas served by HSJDA,

With non-cancer chronic pain already diagnosed and treated for at least 6 months but not relieved by the usual treatment,

Who have explicitly and in writing expressed their desire to participate in the workshops and the study through the Informed Consent document,

Disqualifiers

Patients in the diagnostic phase,

Patients with pain exclusively associated with cancer pathology,

Patients with a life expectancy of less than one year,

Patients with severe cognitive or mental illnesses that prevent them from understanding both the content of the workshops and the measurement instruments.

Trial design

Design model

Parallel

Treatments tested in this trial

Chronic Pain Management Workshop with Non-Pharmacological Therapies
Behavioral
1st Session: Welcome. Expectations. Pathophysiological mechanism of pain. Influence of emotions on pain intensity. Activities: My limiting beliefs; Affirmations in front of the mirror; Mental analgesia. / 2nd: Pain and its impact on the patient's life. Forgiveness and self-forgiveness. Ho'oponopono technique. Self-esteem. Activities: Labels that limit us; Reading "When I Loved Myself for Real"; Self-healing meditation; Life purpose. / 3rd: Tips to slow down aging. Promotion of healthy habits; Metta meditation; Motivation for change. / 4th: Active participation in my own healing. How to face illness. Creative visualization. Activity:Energy wheel. / 5th: Review of the tools. Resolving doubts. Workshop evaluation and scales. Guide with the tools presented. Activities: Final farewell. / At the end of each session, the homework assignments are explained, and at the beginning of the next, they are reviewed. Sessions 2, 3, 4 5: Experience of a previous workshop patient.

Treatment groups

128 Participants

are divided into 2 treatment groups

Group A: WorkshopExperimental treatment 1 intervention

Group B: Traditional treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pain last week

Pain measured with the "visual analogue scale" (scale: 0-10)

Time frame

4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

2

Analgesic regimen

self-assessment at the end of the workshop on whether they have replaced a higher-tier analgesic with a lower one, decreased the dosage, reduced the frequency, or stopped taking analgesics or anxiolytics/antidepressants.

Time frame

4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

3

Well-being

Numerical visual scale from 0 (minimum) to 10 (maximum). Higher scores indicate greater well-being.

Time frame

4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

4

Self-esteem

Rosenberg Self-esteem Scale, ranging from 9 (minimum) to 36 (maximum).Higher scores indicate greater Self-esteem

Time frame

4 measurements: The scale will be administered just before starting the workshop, at the end (last day of the workshop, after 4 weeks), at 3 months, and at 6 months (this only in the intervention group).

Secondary outcomes

1

Satisfaction with the workshop

Satisfaction with the workshop: Clarity of the presented content; Appropriateness of the exercises and activities performed; Usefulness of the workshop for managing my pain; Usefulness of the workshop for managing my illness; To what extent would you recommend this workshop?; Overall satisfaction. Suggestions for improvement are also collected. Scale from 0 to 10.

Time frame

1 measurement: The scale will be administered just at the end (last day of the workshop, after 4 weeks) (this only in the intervention group).

2

Improving habits

In the 3rd session, we work on a self-assessment of certain habits (nutrition, physical exercise, relaxation/meditation, "me time") and ask participants to choose one or two to improve and make the change. At the end of the workshop, we ask them if they have made any habit changes and what those changes were, through the self-assessment questionnaire they complete at the end of the workshop. This is measured as Yes/No.

Time frame

2 measurements: In the 3rd session and just at the end (last day of the workshop, after 4 weeks) (this only in the intervention group).

Management of Chronic Non-Cancer Pain With Non-Pharmacological Therapies

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts