Meditation for Chemotherapy-Induced Nausea and Vomiting in Women With Breast Cancer

NCT07470619 | Completed DMC

• 1 other identifier: PVF2026CINV001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aimed to evaluate the effectiveness of Twin Hearts Meditation in reducing chemotherapy-induced nausea and vomiting among women with breast cancer undergoing chemotherapy. Chemotherapy-related nausea and vomiting are among the most distressing side effects of cancer treatment and can negatively affect patients' quality of life, nutritional status, and adherence to therapy. The study focused on whether regular practice of this meditation technique could significantly reduce the severity of nausea and the frequency of vomiting episodes following chemotherapy. The main research questions were: Does Twin Hearts Meditation reduce chemotherapy-induced nausea and vomiting among women with breast cancer? Can this complementary and non-invasive intervention be considered a supportive strategy for managing chemotherapy-related symptoms? Participants were randomly assigned to either the intervention group, which practiced Twin Hearts Meditation, or the control group, which received routine care without meditation. The intervention group received a 30-minute guided meditation training session and practiced the meditation three times per week for two weeks. Nausea severity and vomiting episodes were assessed using a nausea severity scale and a vomiting record flow sheet at baseline and at 6, 12, 18, and 24 hours after chemotherapy to evaluate the effectiveness of the intervention.

Conditions

Nausea and Vomiting Chemotherapy-Induced; Meditation Training

Keywords

Breast Neoplasms; Meditation; Nursing Care; Nausea

Outcome Measures

Primary Outcomes (1)

• Nausea Severity

  The primary outcome measure evaluates changes in the severity of chemotherapy-induced nausea among women with breast cancer undergoing chemotherapy. Nausea severity is assessed using a Visual Self-Reporting Nausea Scale, scored from 0 to 10, where 0 indicates no nausea and 10 indicates the most severe nausea. Higher scores indicate greater nausea severity

  Nausea severity is assessed at 6, 12, 18, and 24 hours after chemotherapy

Secondary Outcomes (1)

• Frequency of Vomiting Episodes

  Vomiting frequency is assessed at 6, 12, 18, and 24 hours after chemotherapy

Study Arms (2)

Twin Hearts Meditation

EXPERIMENTAL

Behavioral: Twin Hearts Meditation Participants in this group receive Twin Hearts Meditation, a structured mind-body relaxation technique designed to promote emotional balance and psychological well-being. The intervention aims to reduce chemotherapy-induced nausea and vomiting by promoting relaxation, stress reduction, and improved emotional regulation in women with breast cancer undergoing chemotherapy

Behavioral: Twin Heart Meditation

Routine Care

NO INTERVENTION

Participants in the control group received routine clinical care during chemotherapy and did not receive any additional behavioral intervention during the study period.

Interventions

Twin Heart Meditation BEHAVIORAL

Participants in this group received Twin Hearts Meditation, a structured mind-body relaxation technique designed to promote emotional balance and psychological well-being. The intervention included a supervised 30-minute guided meditation session provided by a trained researcher in the chemotherapy unit. Participants were then instructed to continue the meditation practice at home for 30 minutes per session, at least three times per week for two weeks using an audio recording provided by the researcher. The meditation protocol included the following steps: * Light physical warm-up exercises to promote relaxation * Focused attention on positive emotions such as compassion and calmness * Guided meditation to promote mental relaxation and emotional balance * Silent concentration on a repeated phrase * Expression of gratitude * Closing relaxation exercises Regular telephone follow-up was conducted during the intervention period to support adherence to the meditation practice.

Twin Hearts Meditation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-65 years diagnosed with non-metastatic breast cancer.
• Patients undergoing chemotherapy using standard chemotherapy regimens in the oncology unit.
• Patients who had experienced nausea during at least one previous chemotherapy session.
• Patients who voluntarily agreed to participate in the study and provided written informed consent

You may not qualify if:

• Performing meditation fewer than three times per week during the intervention period.
• Unwillingness to continue participation in the study.
• Presence of medical conditions that may independently cause nausea, such as severe gastrointestinal disease, renal failure, or hepatic disease.

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Unknown Facility

Nicosia, KKTC (Turkish Republic of Northern Cyprus), 99138, Cyprus

Location

MeSH Terms

Conditions

Nausea; Breast Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To minimize bias, a single-blind approach was used. The researcher responsible for outcome assessment and data collection was unaware of group allocation. In addition, the statistician who performed the data analysis was blinded to group assignments. The data were analyzed using coded variables (X1 and X2) to maintain objectivity and prevent bias during statistical analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University,

Model Details: Participants were randomly allocated to one of two study arms: an experimental group receiving the Twin Hearts Meditation intervention and a control group receiving routine care. Both groups were observed and evaluated in parallel during the study period.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: June 15, 2016
• Primary Completion: June 15, 2016
• Study Completion: June 30, 2016
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)