Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Participation and Completion Rate of Incorporating a Guided Meditation Program in Participants Undergoing Stereotactic Breast Biopsy (SBB)
研究概览
简要总结
The goal of this behavioral research study is to learn if taking part in guided relaxation programs helps to reduce anxiety and pain during stereotactic breast biopsy. The study will also examine whether the guided relaxation programs change brain activity, heart rate, and blood pressure.
详细描述
Baseline Data Collection:
If participant chooses to take part in this study, they will be asked to fill out several questionnaires on an MD Anderson computer. Participant will be asked questions about anxiety, pain, and spirituality. The questionnaires will take about 20 minutes to complete.
Participant will have their heart rate and blood pressure taken, which will take about 3 minutes to complete. Participant will then have an electroencephalogram (EEG) done. An EEG is used to view a person's brain waves. The EEG should take about 5 minutes to complete. During the EEG, a snug cap which contains small electrodes will be placed on the head to measure the electrical patterns coming from the brain--much like the way a doctor listens to participant's heart from the surface of their skin. The EEG cap will stay on participant's head until the end of the study.
Study Groups:
After the baseline information is collected, participant will be randomly assigned (as in the role of a die) to 1 of 3 study groups: 2 relaxation training groups or a standard care group. Based on the way the study is designed, there is a 1 in 5 (or 20%) chance that participant will be assigned to the standard care group, and a 4 in 5 (or 80%) chance that participant will be assigned to one of the relaxation groups. Both relaxation groups will focus on helping participant to relax by focusing on their breath. At the end of participation, all groups will be given a 25 minute relaxation audio CD created by the MD Anderson Integrative Medicine Program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
- •Women must be right hand dominant.
- •Women must be 18 years or older.
排除标准
- •Women who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
- •Women with a score of 3 or below on the Six-Item Cognitive Screener.
- •Women who plan to take benzodiazepine (e.g, alprazolam, diazepam, clonazepam, lorazepam) or beta-blocker (e.g., propranolol, atenolol) on the day of their SBB.
结局指标
主要结局
Participation and Completion Rate of Incorporating a Guided Meditation Program in Participants Undergoing Stereotactic Breast Biopsy (SBB)
时间窗: 1 day
Trial considered successful if over 50% of eligible patients participate and at least 80% of the consented patients complete the sessions and all the measures for the study.
次要结局
- Effect of GM Compared to Focused Breathing (FB) and Standard Care (SC) Control Groups on Self-Reported Anxiety in Participants Undergoing SBB(3-5 minute intervals throughout the SBB procedure)