Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118853
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-10-24
Brief Title:
Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing HSCT
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation at the Hospital Israelita Albert Einstein
Status:
RECRUITING
Status Verified Date:
2023-10
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:
Yoga
Brief Summary:
This project aims to observe the impact of yoga and gentle massage practices on symptom management in patients undergoing Hematopoietic Stem Cell Transplantation HSCT at the Israelite Albert Einstein Hospital It is a prospective open label randomized clinical study comparing the practice of yoga or gentle massage combined with standard treatment versus standard treatment alone Using the Edmonton Symptom Assessment System in 8 sessions the investigators will analyze the domains of fatigue pain nausea anxiety and well-being before and after each session The investigators will also assess Quality of Life - BMT changes in Religiosity Scale before and after the intervention and at the end Patient Satisfaction and subjective experience through a qualitative questionnaire The hypothesis is that the practice of yoga and gentle massage combined with standard treatment is superior to standard treatment alone in symptom management in patients undergoing HSCT
Detailed Description:
Primary Objective To assess the impact of yoga andor gentle massage practices plus standard treatment versus standard treatment alone on symptom management in patients undergoing Hematopoietic Stem Cell Transplantation HSCT evaluated using the Edmonton Symptom Assessment Scale ESAS
Secondary Objectives
To analyze changes in the Quality-of-Life Scale during HSCT
To analyze changes in the Religiosity Scale during HSCT
To analyze the subjective experience of the patient during HSCT
To analyze patient satisfaction during HSCT Hypothesis The practice of yoga or gentle massage combined with standard treatment is superior to standard treatment alone in symptom management in patients undergoing HSCT
Population The study will be conducted at the Hospital Israelita Albert Einstein HIAE with patients admitted to the Oncology and Hematology Center for Bone Marrow Transplantation Only after obtaining Informed Consent IC from the patient clinical and sociodemographic variables during hospitalization will be extracted from the institutional electronic medical record database age gender monthyear and type of transplant conditioning intensity donor type cell source and underlying disease
Inclusion Criteria Adults aged 18 and above admitted to HIAE eligible for Bone Marrow Transplantation patients who speak and read Portuguese
Exclusion Criteria Patients with hearing impairment patients previously diagnosed with psychiatric disorders schizophrenia
Sample Size The sample will consist of a minimum of 40 patients for this study
Based on a pilot sample n 40 with only one session of yoga or gentle massage a variation of 158 points SD 158 points in fatigue improvement was observed To find a mean difference of at least 15 points between the intervention group yoga or gentle massage plus standard treatment and the control group standard treatment alone in the proposed 8 sessions with a power of 80 and a confidence level of 95 the required sample size for the study would be 18 patients in each group Since in addition to fatigue other parameters such as pain nausea anxiety and well-being will also be evaluated the investigators will use a sample of at least 20 patients per group to account for these parameters as well totaling at least 40 patients in the study
Randomization Randomization will be carried out according to the randomization block generated by the Redcap tool Therefore upon agreeing to participate in the protocol each patient will be entered into Redcap and randomized according to the specified parameters stratified by age groups 18 to 40 41 to 60 above 61 years and by type of transplant autologous allogeneic and umbilical cord
Secondary Objectives
To analyze changes in the Quality-of-Life Scale during HSCT
To analyze changes in the Religiosity Scale during HSCT
To analyze the subjective experience of the patient during HSCT
To analyze patient satisfaction during HSCT Hypothesis The practice of yoga or gentle massage combined with standard treatment is superior to standard treatment alone in symptom management in patients undergoing HSCT
Population The study will be conducted at the Hospital Israelita Albert Einstein HIAE with patients admitted to the Oncology and Hematology Center for Bone Marrow Transplantation Only after obtaining Informed Consent IC from the patient clinical and sociodemographic variables during hospitalization will be extracted from the institutional electronic medical record database age gender monthyear and type of transplant conditioning intensity donor type cell source and underlying disease
Inclusion Criteria Adults aged 18 and above admitted to HIAE eligible for Bone Marrow Transplantation patients who speak and read Portuguese
Exclusion Criteria Patients with hearing impairment patients previously diagnosed with psychiatric disorders schizophrenia
Sample Size The sample will consist of a minimum of 40 patients for this study
Based on a pilot sample n 40 with only one session of yoga or gentle massage a variation of 158 points SD 158 points in fatigue improvement was observed To find a mean difference of at least 15 points between the intervention group yoga or gentle massage plus standard treatment and the control group standard treatment alone in the proposed 8 sessions with a power of 80 and a confidence level of 95 the required sample size for the study would be 18 patients in each group Since in addition to fatigue other parameters such as pain nausea anxiety and well-being will also be evaluated the investigators will use a sample of at least 20 patients per group to account for these parameters as well totaling at least 40 patients in the study
Randomization Randomization will be carried out according to the randomization block generated by the Redcap tool Therefore upon agreeing to participate in the protocol each patient will be entered into Redcap and randomized according to the specified parameters stratified by age groups 18 to 40 41 to 60 above 61 years and by type of transplant autologous allogeneic and umbilical cord
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