A Mindfulness-Based Self-Compassion Program

NCT ID: NCT06846060

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-04-07

Brief Summary

The purpose of this study is a pre-test-post-test, randomized controlled experimental study with a control group, planned to examine the effect of the mindfulness-based self-compassion program applied on women with breast cancer on spiritual well-being and self-compassion levels.

Detailed Description

The research was designed experimentally. The research will be conducted between February 2025 and April 2025 with female patients diagnosed with breast cancer who were treated in the oncology service of Cumhuriyet University Faculty of Medicine hospital in Sivas-Central province in the middle of Turkey and who meet the inclusion criteria. The study will be carried out face to face after obtaining the necessary institutional permissions. Participants to be included in the research will be included in the sample by taking into account the inclusion criteria at each stage. After the subject, purpose and method of the study are explained to the participants to be included in the study, they will be asked to fill out the informed consent form. Participants will then be divided into intervention and control groups by simple randomization method. Before the intervention, an information form, Self-Compassion Scale and Spiritual Well-Being Scale (FACIT-SP-12) will be applied to both groups. The implementation of the study will be carried out at the patient's convenience, in a time period that will not interfere with his treatment in any way, and in a special area determined by the hospital management, while preserving his privacy. A mindfullness-based intervention program consisting of 8 sessions will be applied to the Intervention Group. No intervention will be applied to the control group. At the end of the intervention program, the Self-Compassion Scale and Spiritual Well-Being Scale (FACIT-SP-12) will be administered to both groups.

Conditions

Breast Cancer Survivor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

intervention group

A mindfullness-based intervention program consisting of 8 sessions will be applied to the Intervention Group Awareness program intervention programs (Mindfullness) are a special comprehensive program that integrates the body and mind and consists of payments related to temporary local treatment of current yoga, diversity and awareness of the moment. According to the literature, the self-compassion program kept at home for 8-year-olds consists of 8 recordings in total, two recordings per week in groups of 8 people. He has goals and objectives specific to his personal record and yet there is a separate relationship day with the subject of his one information.

Group Type: EXPERIMENTAL

Mindfulness-Based Self-Compassion Program

Intervention Type: BEHAVIORAL

Mindfulness-based intervention programs are a program that includes a special session in which body and mind are integrated, and consists of homework for participants on yoga, meditation and a mindfulness-based approach to vital events in order to be aware of the moment. The conscious awareness-based self-compassion program, created in line with the literature, consists of 8 sessions in total, in groups of 5-8 people, on the same day and time every week. There are specific goals and objectives for each session, and each session also has a separate theme along with its subject.

Control group

No intervention will be applied to the control group. Before and after the intervention program, the Coopersmith Self-Esteem Scale (GISS) and Spiritual Well-Being Scale (FACIT-SP-12) will be applied to the cotra group simultaneously with the experimental group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness-Based Self-Compassion Program

Mindfulness-based intervention programs are a program that includes a special session in which body and mind are integrated, and consists of homework for participants on yoga, meditation and a mindfulness-based approach to vital events in order to be aware of the moment. The conscious awareness-based self-compassion program, created in line with the literature, consists of 8 sessions in total, in groups of 5-8 people, on the same day and time every week. There are specific goals and objectives for each session, and each session also has a separate theme along with its subject.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women diagnosed with breast cancer,
• Women who are aware that they have been diagnosed with breast cancer,
• Women who volunteer to participate in the study,
• Women over the age of 18 with sufficient communication skills

Exclusion Criteria

• Being diagnosed with any mental illness

• Minimum Eligible Age: 18 Days
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nevsehir Haci Bektas Veli University

OTHER

Sponsor Role: lead

Responsible Party

Semra seyhan Şahin

RESEARCH ASSISTANT DR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SEMRA SEYHAN SAHİN, Dr.

Role: PRINCIPAL_INVESTIGATOR

Nevsehir Haci Bektas Veli University

Locations

Cumhuriyet University Medical Faculty Hospital

Sivas, Center, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

SEMRA SEYHAN ŞAHİN, R.A. (DR)

Role: CONTACT

semraseyhan06@gmail.com

TURKEY +905442689113

Facility Contacts

BASHEKİM BEY, DR

Role: primary

hastaneyaziisleri@gmail.com

+903462261326

Other Identifiers

NEVU-NRS-SS-02

Identifier Type: -

Identifier Source: org_study_id