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

NCT06118853 | Completed DMC

• 1 other identifier: 61711022.6.0000.0071
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantation; Bone Marrow Transplantation

Keywords

Hematopoietic Stem Cell Transplantation; Bone Marrow Transplantation; Integrative Therapies; Yoga; Massage

Outcome Measures

Primary Outcomes (1)

• Symptom Management: fatigue, pain, nausea, anxiety, and well-being

  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 Outcomes (4)

• 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).

• Qualitative Report

  Day 21 or at discharge (whichever comes first).

• Patient-Reported Experience Measures

  Day 21 or at discharge (whichever comes first).

Study Arms (2)

Group A (control)

NO INTERVENTION

Standard treatment for HSCT

Group B (intervention)

EXPERIMENTAL

Yoga or gentle massage plus standard treatment for HSCT

Behavioral: yoga or gentle massage plus standard treatment for HSCT

Interventions

yoga or gentle massage plus standard treatment for HSCT 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.

Group B (intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 and above;
• Admitted to HIAE, eligible for Bone Marrow Transplantation;
• Patients who speak and read the Portuguese language.

You may not qualify if:

• Patients with hearing impairment;
• Patients previously diagnosed with psychiatric disorder: schizophrenia.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Maria Ester Azevedo Massola

São Paulo, São Paulo, 05653000, Brazil

Location

Related Publications (35)

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MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Nelson Hamerschlak

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 7, 2023
• Study Start: November 21, 2023
• Primary Completion: December 30, 2024
• Study Completion: March 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)