Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation at the Hospital Israelita Albert Einstein
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Symptom Management: fatigue, pain, nausea, anxiety, and well-being
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 and above;
- •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.
Arms & Interventions
Group A (control)
Standard treatment for HSCT
Group B (intervention)
Yoga or gentle massage plus standard treatment for HSCT
Intervention: yoga or gentle massage plus standard treatment for HSCT (Behavioral)
Outcomes
Primary Outcomes
Symptom Management: fatigue, pain, nausea, anxiety, and well-being
Time Frame: The sessions will occur at the following time points: Session 1 and 2 - from admission to Day 0 (infusion) / Session 3 and 4: between Day 1 and Day 7 / Session 5 and 6: between Day 8 and Day 14 / Session 7 and 8: between Day 15 and Day 21 or discharge.
The Edmonton Symptom Assessment Scale will be administered both before and after each of the 8 sessions in both groups to evaluate pain, fatigue, nausea, anxiety, and well-being. The scale for each domain ranges from 0 to 10, where 0 signifies no symptoms or excellent well-being, and 10 signifies the most severe symptoms or worst possible well-being.
Secondary Outcomes
- Patient-Reported Experience Measures(Day 21 or at discharge (whichever comes first).)
- Qualitative Report(Day 21 or at discharge (whichever comes first).)
- Scale of Quality-of-Life(Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).)
- Scale of Religiosity(Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).)