Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-14
Brief Title:
Management of Chronic Non-Cancer Pain With Non-Pharmacological Therapies
Sponsor:
Hospital San Juan de Dios del Aljarafe de Sevilla
Organization:
Hospital San Juan de Dios del Aljarafe de Sevilla
Study Overview
Official Title:
Management of Chronic Non-Cancer Pain With Non-Pharmacological Therapies Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 35 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 GPOWER 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 005 power of 080 and an effect size of 05 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 270 will be used
To compare the main and secondary dependent variables between the control and intervention groups hypothesis testing will be performed Students 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 Pearsons or Spearmans 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 Fishers 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 20072023 under record CEI_072023 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 -CPMPICH13595- Law 412002 of November 14 regulating patient autonomy Law 142007 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 2016679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 27 2016 Directive 9546EC and Organic Law 32018 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
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 35 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 GPOWER 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 005 power of 080 and an effect size of 05 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 270 will be used
To compare the main and secondary dependent variables between the control and intervention groups hypothesis testing will be performed Students 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 Pearsons or Spearmans 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 Fishers 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 20072023 under record CEI_072023 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 -CPMPICH13595- Law 412002 of November 14 regulating patient autonomy Law 142007 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 2016679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 27 2016 Directive 9546EC and Organic Law 32018 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None