Trial Title:
Management of Chronic Non-Cancer Pain With Non-Pharmacological Therapies
NCT ID:
NCT06440668
Condition:
Chronic Pain Syndrome
Sensitization, Central
Quality of Life
Patient Empowerment
Conditions: Official terms:
Chronic Pain
Conditions: Keywords:
Chronic Pain Syndrome
Sensitization, Central
Quality of Life
Patient Empowerment
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomised controlled clinical trial
Primary purpose:
Supportive Care
Masking:
Single (Investigator)
Masking description:
The statistician who analyse the data is unaware of the group to which each patient
belonged.
Intervention:
Intervention type:
Behavioral
Intervention name:
Chronic Pain Management Workshop with Non-Pharmacological Therapies
Description:
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.
Arm group label:
Workshop
Summary:
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.
Detailed description:
Intervention Group: Workshop. This group starts and completes the workshop (attend at
least 4 out of the 5 sessions). Complete all the initial documentation, at the end of the
workshop, and at the 3-month mark. Perform daily tracking of the 3 mandatory activities
throughout the duration of the workshop.
Control Group: Traditional treatment. This group meets the inclusion criteria but does
not participate in the workshop. They complete all documentation at the beginning, at one
month, and at three months. These patients will continue with the usual treatment
prescribed by their doctor.
Intervention: Chronic Pain Management Workshop with Non-Pharmacological Therapies.
Psychoeducational and self-care training, pain management, and emotional control,
conducted in groups and aimed at patients with non-cancer chronic pain.
Workshop Methodology and Facilities: It will take place at HSJDA over 5 afternoons, with
each session lasting 3.5 hours. Sessions will be held once a week for 5 consecutive
weeks.
The sessions will include oral presentations supported by PowerPoint, videos, activities
to be performed in the classroom by the patients to apply different techniques,
testimonies from individuals known for personal overcoming, experiences from patients of
previous workshops, and the application of the explained tools.
In the first session, a WhatsApp group will be created with the participants of each
workshop, coordinated by a volunteer patient, who will directly contact the workshop
director. The director will send reinforcement information from the workshop sessions,
such as videos and songs, through this group.
Patients can ask questions via the group, which will be directed from the patient
coordinator to the workshop director for resolution. They can also report any issues
regarding attendance to a session.
This group will remain active for up to 6 months to serve as reinforcement and a support
group for the patients. At the end of each session, patients will be given some homework
for the week, as well as a tracking sheet to record 3 activities they must perform daily
and an assessment of pain control using the main technique (to be filled out daily until
the workshop ends).
In the last session, there will be a review of all the tools presented in previous
sessions, questions will be answered, and patients will evaluate the workshop
(satisfaction, most useful aspects, etc.), as well as its impact on pain control and
other aspects (quality of life, self-esteem, mood, etc.). They can also provide
suggestions for improvement and free-text comments.
At the end of the workshop, patients will receive a guide reinforcing what was explained
in the workshop so they can continue applying the tools and recommendations after the
workshop ends.
Patient Recruitment: Patients will be referred by healthcare professionals from the
following services or areas: Rehabilitation, Traumatology, Internal Medicine, Gynecology,
etc. Primary Care: Health Centers in the Aljarafe Area belonging to the Aljarafe-Sevilla
Norte Health District. Associations of patients with conditions associated with
non-cancer chronic pain.
Sample Selection: Each referred patient will be interviewed by phone by the workshop
director to confirm they meet the inclusion criteria. If they do, they will be informed
about the workshop, invited to participate in the study, and if they accept, they will be
sent the information sheet and informed consent via email, to be returned signed by
email.
All those who accept will be added to the list of workshop candidate patients registered
in Excel. Participants will be assigned to each group (control and intervention) using
the Excel "RAND" function, which assigns a random number to each patient, then sorted
from smallest to largest, with the first half forming the control group and the other
half forming the intervention group.
Sample Size: Each workshop will include a maximum of 20 patients. A 20% dropout rate is
expected (patients missing two or more sessions), so approximately 16 patients are
expected to complete each workshop. Using G*POWER software, the sample size calculation
was performed using an independent samples t-test to compare means of two groups (control
and experimental), considering a significance level of 0.05, power of 0.80, and an effect
size of 0.5 (conservative size), resulting in a sample size of 128 patients (64 in each
group).
Workshops will be conducted until the required sample size is recruited. Considering a
20% dropout rate, 4 workshops will be needed, recruiting 80 patients (20 per workshop),
expecting 80% to complete the workshops, resulting in 64 patients, meeting the minimum
sample size required.
Workshop Follow-up: Both control and experimental groups will undergo 3 measurements:
initial, one month (workshop end), and three months, completing the clinical trial.
Additionally, the experimental group will have a follow-up one month after completion
(two months from the start), presenting group results (anonymized) and a brief
personalized report of their results. Another follow-up will occur at six months to
assess if the workshop effect persists long-term, with the scales administered again.
Statistical Analysis: With the documentation collected at the beginning of the study, the
random allocation will be ratified, checking the comparability of all variables that may
influence the final outcome. Descriptive statistics will be performed in each group:
Continuous quantitative variables: mean and SD (if they follow a normal distribution);
median and quartiles (if they do not follow a normal distribution). Categorical
variables: Absolute and relative frequencies (%). The normality of the variables will be
checked with the Kolmogorov-Smirnov test.
95% confidence intervals will be calculated for means and percentages. At the end of the
study, an intention-to-treat analysis will be performed. The Statistical Package for
Social Sciences (SPSS) Version 27.0 will be used.
To compare the main and secondary dependent variables between the control and
intervention groups, hypothesis testing will be performed: Student's t-test and ANOVA
(for quantitative variables that follow a normal distribution), Mann-Whitney U and
Kruskal-Wallis (for those with a non-normal distribution) when comparing 2 or more
groups, respectively.
To compare related variables (before and after) both within the control group and within
the intervention group, paired t-tests will be used for normally distributed data, and
the Wilcoxon test for non-normally distributed data.
The correlation between outcome variables will also be assessed using Pearson's or
Spearman's correlation coefficient, depending on whether the variables compared follow a
normal distribution or not. The normality of quantitative variables will be checked using
the Kolmogorov-Smirnov test.
For qualitative variables, the Chi-square test or Fisher's test (if expected frequencies
are low) will be used to compare independent variables, and the McNemar test to compare
related variables.
Finally, a multivariate analysis will be conducted to develop an explanatory model with
the main variables that influence the outcomes. The Odds Ratio of the associations with
their confidence intervals will be calculated.
Bioethical considerations. This project, has received favorable approval from the
Research Ethics Committee of the University Hospitals Virgen Macarena and Virgen del
Rocío at its meeting on 20/07/2023, under record CEI_07/2023. Internal Code: 1181-N-23.
Researchers involved in this project will ensure compliance with current regulations and
legislation governing research involving human subjects (Declaration of Helsinki and its
update in Fortaleza (Brazil), Oviedo Declaration, Good Clinical Practice Guide of the ICH
-CPMP/ICH/135/95-, Law 41/2002 of November 14, regulating patient autonomy, Law 14/2007
of July 3, on biomedical research).
Individuals participating in this project must have provided written consent once they
have been adequately informed and their questions have been addressed. Researchers will
ensure the anonymity and the confidentiality of participants' data (recommendations of
REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 27, 2016;
Directive 95/46/EC and Organic Law 3/2018, of December 5, on Personal Data Protection and
guarantee of digital rights. Two databases (DB) will be worked with and kept in different
files. In DB-1, the NID (patient identification number) will be related to personal data.
The NID is a unique number for each patient. In DB-2, the NID will be related to
patients' clinical data.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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,
- And who complete the initial documentation necessary for their evaluation.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
María Victoria RUIZ ROMERO
Address:
City:
Bollullos de la Mitación
Zip:
41110
Country:
Spain
Contact:
Last name:
María Victoria MV Ruiz Romero, PhD
Phone:
664396621
Email:
mariavictoria.ruiz@sjd.es
Contact backup:
Email:
consuelomaria.pereira@sjd.es
Investigator:
Last name:
Consuelo CM Pereira-Delgado, Dr
Email:
Sub-Investigator
Investigator:
Last name:
Ana A Porrúa Del Saz, Graduate
Email:
Sub-Investigator
Investigator:
Last name:
Begoña B Gómez Hernández, Graduate
Email:
Sub-Investigator
Investigator:
Last name:
Blanca María BM Martínez-Monrobé, Graduate
Email:
Sub-Investigator
Start date:
June 10, 2024
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Hospital San Juan de Dios del Aljarafe de Sevilla
Agency class:
Other
Source:
Hospital San Juan de Dios del Aljarafe de Sevilla
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06440668
