Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing HSCT
NCT ID: NCT06118853
Last Updated: 2025-03-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
35 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-11-21
Study Completion Date
2025-03-01
Brief Summary
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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.
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Detailed Description
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Primary Objective: To assess the impact of yoga and/or 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, month/year 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 1.58 points (SD = 1.58 points) in fatigue improvement was observed. To find a mean difference of at least 1.5 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, month/year 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 1.58 points (SD = 1.58 points) in fatigue improvement was observed. To find a mean difference of at least 1.5 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.
Conditions
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Hematopoietic Stem Cell Transplantation
Bone Marrow Transplantation
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Patients will be randomized into two groups: Group A (control): standard treatment /Group B (intervention): yoga + gentle massage + standard treatment. Group B (intervention) will receive 8 individual integrative practice sessions at the bedside, each lasting 15 to 20 minutes, with 2 sessions per week during the following periods: from admission until D+0 / until D+7 / until D+14 / until D+21 or discharge. The therapist will choose the integrative practices that best suit the patient for each session, based on their psychophysical state and symptoms, as there can be many variations during HSCT. Group A (control) will receive 8 visits from integrative therapists who will remain in the patient's room, able to interact but without offering integrative practices, during the same periods described above. After D+21, these patients will also receive 8 integrative practice sessions at the bedside or in the Integrative Medicine room.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Group A (control)
Standard treatment for HSCT
Group Type
NO_INTERVENTION
No interventions assigned to this group
Group B (intervention)
Yoga or gentle massage plus standard treatment for HSCT
Group Type
EXPERIMENTAL
yoga or gentle massage plus standard treatment for HSCT
Intervention Type
BEHAVIORAL
The yoga sessions will be conducted at the patient's bedside, using one or more of the following techniques: gentle stretches (asanas), guided relaxation (savasana), slow and deep diaphragmatic breathing (pranayama), and meditative exercises focusing on natural breathing or visualization of a soothing place (dhyana). From these techniques, the integrative therapist will choose what best suits the patient for each session, based on their psychophysical state and symptoms presented, as there can be many variations during HSCT. Gentle massage is characterized by soft touches using light pressure, primarily using the palm of the hand, with a slow and steady rhythm across the entire body. It can be performed over clothing or even over the bedsheet and blanket.
Interventions
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yoga or gentle massage plus standard treatment for HSCT
The yoga sessions will be conducted at the patient's bedside, using one or more of the following techniques: gentle stretches (asanas), guided relaxation (savasana), slow and deep diaphragmatic breathing (pranayama), and meditative exercises focusing on natural breathing or visualization of a soothing place (dhyana). From these techniques, the integrative therapist will choose what best suits the patient for each session, based on their psychophysical state and symptoms presented, as there can be many variations during HSCT. Gentle massage is characterized by soft touches using light pressure, primarily using the palm of the hand, with a slow and steady rhythm across the entire body. It can be performed over clothing or even over the bedsheet and blanket.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Adults aged 18 and above;
* Admitted to HIAE, eligible for Bone Marrow Transplantation;
* Patients who speak and read the Portuguese language.
* Admitted to HIAE, eligible for Bone Marrow Transplantation;
* Patients who speak and read the Portuguese language.
Exclusion Criteria
* Patients with hearing impairment;
* Patients previously diagnosed with psychiatric disorder: schizophrenia.
* Patients previously diagnosed with psychiatric disorder: schizophrenia.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital Israelita Albert Einstein
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Nelson Hamerschlak
Role: PRINCIPAL_INVESTIGATOR
Hospital Israelita Albert Einstein
Locations
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Maria Ester Azevedo Massola
São Paulo, São Paulo, Brazil
Site Status
Countries
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Brazil
References
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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61711022.6.0000.0071
Identifier Type: -
Identifier Source: org_study_id
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