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.

Study Title

The Effect of Twin Hearts Meditation on Chemotherapy-Induced Nausea and Vomiting in Women With Breast Cancer

Study Purpose

The aim of this study was to investigate the effectiveness of Twin Hearts Meditation, a mind-body relaxation technique used in complementary and alternative medicine, in reducing chemotherapy-induced nausea and vomiting among women with breast cancer. Chemotherapy-related nausea and vomiting remain common and distressing side effects despite the routine use of antiemetic medications. This study evaluates whether meditation can serve as a supportive non-pharmacological intervention to reduce symptom severity and improve patient comfort during chemotherapy treatment.

Sample Size Determination

The study population consisted of women diagnosed with breast cancer who were receiving chemotherapy at the oncology unit of a public hospital in Iran. Based on findings from a similar study and using a mean comparison formula with a significance level of 0.05 and statistical power of 80%, the required sample size was calculated as 48 participants per group.

To account for possible dropout, 55 participants were recruited for each group. A total of 110 participants were initially enrolled and randomly allocated into experimental and control groups. During the study period, eight participants were excluded due to non-adherence to the meditation protocol or withdrawal from the study, resulting in a final sample of 102 participants.

Randomization was performed using a simple randomization method. Numbers from 1 to 110 were written on cards and placed in a container. The cards were then drawn sequentially and assigned alternately to the experimental and control groups to ensure equal allocation and reduce selection bias.

Blinding Procedure

This study was conducted as a single-blind randomized controlled trial. The researcher responsible for data collection was unaware of group allocation. In addition, the statistician who analyzed the data was blinded to group assignments and analyzed the coded data.

Tools of Data Collection

A) Demographic Questionnaire This questionnaire collected baseline information including age, marital status, education level, occupation, place of residence, duration of illness, number of chemotherapy sessions, and chemotherapy regimen.

B) Nausea Severity Scale (Visual Self-Reporting Scale) Nausea severity was assessed using a visual scale ranging from 0 to 10, where 0 indicated no nausea and 10 indicated the most severe nausea. Scores of 1-3 represented mild nausea, 4-6 moderate nausea, and 7-10 severe nausea.

C) Vomiting Record Flow Sheet The frequency of vomiting episodes was recorded using a standardized flow sheet completed by participants after chemotherapy.

Nausea and vomiting were assessed at baseline and at 6, 12, 18, and 24 hours after chemotherapy.

Intervention

Experimental Group Participants received both theoretical and practical training in Twin Hearts Meditation delivered by the researcher, who was certified in teaching this meditation technique. The initial session included a supervised 30-minute guided meditation practice.

Participants were instructed to perform meditation three times per week for two weeks at home using an audio recording provided by the researcher.

1. Five minutes of light physical exercises to promote relaxation and energy circulation. Praying
2. Offering a short prayer or intention setting.
3. Activation of the acupuncture point (heart chakra) by focusing on feelings of love and compassion.
4. Activation of the acupuncture point (crown chakra) to enhance awareness and emotional balance.
5. Focused meditation while concentrating on the word "Amen."
6. Expressing gratitude for blessings received.
7. Five minutes of physical activity to stabilize the body's energy after meditation

Control Group Participants in the control group received routine care and standard chemotherapy management without any meditation intervention.

Implementation Phase

After explaining the study objectives and procedures, written informed consent was obtained from all participants. Eligible patients were randomly assigned to either the experimental group or the control group. Meditation training sessions were conducted in a quiet room within the chemotherapy ward. Participants in both groups completed baseline and follow-up assessments during the chemotherapy cycle.

Ethical Considerations

This study was approved by the Ethics Committee of Arak University of Medical Sciences (Approval No. IR.ARAKMU.REC.1394.174). The study was conducted in accordance with the ethical principles of the Declaration of Helsinki (1964).

Participants were informed about the study procedures and their right to withdraw from the study at any time without consequences. Written informed consent was obtained from all participants, and confidentiality of participant data was maintained throughout the study.

Statistical Analysis

All data are analyzed using SPSS version 20. Descriptive statistics (mean, standard deviation, and frequencies) are used to summarize the data.

Inferential statistical methods include:

Kolmogorov-Smirnov test to assess normality Paired t-test to evaluate pre- and post-intervention changes within each group Independent t-test to compare differences between the two groups Chi-square test or Fisher's exact test for analysis of categorical variables A significance level of P < 0.05 is considered statistically significant for all analyses.

Inclusion Criteria:

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

Exclusion Criteria:

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

There is no plan to make IPD available to other researchers

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.