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

January 9, 2024 updated by: Hospital Israelita Albert Einstein

Impact of Yoga and Gentle Massage Practices on Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation at the Hospital Israelita Albert Einstein

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05653000
        • Recruiting
        • Maria Ester Azevedo Massola
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nelson Hamerschlak, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group A (control)
Standard treatment for HSCT
Experimental: Group B (intervention)
Yoga or gentle massage plus standard treatment for HSCT
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scale of Quality-of-Life
Time Frame: Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
The investigators will use the Functional Assessment Cancer Therapy - Bone Marrow Transplantation scale, which is a quality-of-life questionnaire designed to measure aspects of quality of life related to bone marrow transplantation. The scale ranges from 0, representing the worst possible quality of life or well-being, to 148, indicating the highest quality of life or well-being. This scale has been translated into Portuguese and validated for use in Brazilian patients.
Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
Scale of Religiosity
Time Frame: Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
The Duke University Religion Index is a brief instrument for assessing aspects related to religiosity. The scale consists of five items that capture three dimensions of religiosity most related to health outcomes: organizational, non-organizational, and intrinsic religiosity. The score ranges from 1 to 27, with higher scores indicating greater religiosity. The scale has been translated into Portuguese and validated for use in Brazilian patients.
Two assessment points: upon admission and on Day 21 or at discharge (whichever comes first).
Qualitative Report
Time Frame: Day 21 or at discharge (whichever comes first).
On Day 21, a Qualitative Report will be presented through RedCap, and patients will be invited to provide a written response to an open question: "How was your experience with Integrative Medicine?"
Day 21 or at discharge (whichever comes first).
Patient-Reported Experience Measures
Time Frame: Day 21 or at discharge (whichever comes first).
Investigators will utilize Patient-Reported Experience Measures with a scale ranging from 1 to 25, where higher scores indicate better patient experience and satisfaction.
Day 21 or at discharge (whichever comes first).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Nelson Hamerschlak, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2023

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 61711022.6.0000.0071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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