Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing HSCT — Yoga  

Hematopoietic Stem Cell Transplantation Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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.

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. ;

Related Conditions & MeSH terms

• Bone Marrow Transplantation
• Hematopoietic Stem Cell Transplantation

• NCT number: NCT06118853
• Study type: Interventional
• Source: Hospital Israelita Albert Einstein
• Contact: Maria Ester A Massola, BA
• Phone: 55 11 996856500
• Email: ester.azevedo@einstein.br
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Completion date: March 31, 2025