Acupressure for Anxiety: A Randomized Controlled Trial of an Acupressure Intervention for Patients Receiving Cancer-Directed Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in acute anxiety
研究概览
简要总结
This clinicaI trial is being done to determine if acupressure is helpful to reduce anxiety related to chemotherapy, compared with "sham" (or placebo) acupressure in patients with cancer. Anxiety, experienced by many patients with cancer, can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. Some patients diagnosed with cancer express interest in non-medicine ways to manage symptoms. Acupressure is the application of non-invasive finger pressure along energy points throughout the body in order to relieve pain and induce a feeling of well-being. Previous research has shown that acupressure can help both adults and children with their anxiety in certain situations, such as after surgery. Patients can be taught how to do the acupressure on themselves, making this an intervention that can be done anywhere. Acupressure is well tolerated with minimal reports of adverse reactions. Undergoing acupressure may be effective in reducing anxiety in cancer patients receiving chemotherapy.
详细描述
PRIMARY OBJECTIVE:
I. To test the efficacy of a nurse-applied acupressure intervention for anxiety associated with active cancer-directed therapy.
SECONDARY OBJECTIVES:
I. To test the efficacy of a patient-applied acupressure intervention for anxiety associated with active cancer-directed therapy.
II. To assess whether acupressure appears to improve nausea related to cancer and cancer-directed therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Patients are blinded during intervention only and unblinded following intervention completion
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NURSE-LED INTERVENTION: Age >= 18 years and be diagnosed with cancer
- •NURSE-LED INTERVENTION: Undergoing systemic, antineoplastic therapy
- •NURSE-LED INTERVENTION: Ability to provide oral consent
- •NURSE-LED INTERVENTION: Willingness to undergo a nurse-led acupressure intervention
- •NURSE-LED INTERVENTION: Willingness and ability to complete pre- and post-intervention questionnaires in English
- •NURSE-LED INTERVENTION: Report acute anxiety as a 5 or higher on a scale for 0 (no anxiety) to 10 (severe anxiety)
- •SELF-ADMINISTRATION INTERVENTION: Age >= 18 years and be diagnosed with cancer
- •SELF-ADMINISTRATION INTERVENTION: Undergoing systemic, antineoplastic therapy
- •SELF-ADMINISTRATION INTERVENTION: Ability to provide oral consent
- •SELF-ADMINISTRATION INTERVENTION: Willingness to undergo a nurse-led acupressure intervention
- •SELF-ADMINISTRATION INTERVENTION: Willingness and ability to complete pre- and post-intervention questionnaires in English
- •SELF-ADMINISTRATION INTERVENTION: Report acute anxiety as a 5 or higher on a scale for 0 (no anxiety) to 10 (severe anxiety)
- •SELF-ADMINISTRATION INTERVENTION: Reports 2+/day anxiety episodes at home
- •SELF-ADMINISTRATION INTERVENTION: Interested in learning self-administered acupressure
排除标准
- •Prior experiences with acupressure, or training in acupressure points
研究组 & 干预措施
Arm I (true acupressure)
Patients undergo true acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.
干预措施: Health Promotion and Education (Other)
Arm I (true acupressure)
Patients undergo true acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.
干预措施: Acupressure Therapy - self-administered (Procedure)
Arm I (true acupressure)
Patients undergo true acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.
干预措施: Acupressure Therapy (Procedure)
Arm I (true acupressure)
Patients undergo true acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.
干预措施: Survey Administration (Other)
Arm II (sham acupressure)
Patients undergo sham acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.
干预措施: Acupressure Therapy - placebo (Procedure)
Arm II (sham acupressure)
Patients undergo sham acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.
干预措施: Acupressure Therapy - self-administered (Procedure)
Arm II (sham acupressure)
Patients undergo sham acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.
干预措施: Health Promotion and Education (Other)
Arm II (sham acupressure)
Patients undergo sham acupressure over 10 minutes on study. Patients that choose to learn self-administration acupressure at home receive educational information and undergo self-administration acupressure sessions at least BID for seven days.
干预措施: Survey Administration (Other)
结局指标
主要结局
Change in acute anxiety
时间窗: Up to 2 weeks
Will be compared between treatment groups. This will be measured by changes in responses to a single item, "Please rate the following symptoms, based on how you feel at the current time (please indicate the one most correct response)," with responses provided on a Likert scale from 0 (no anxiety) to 10 (worst possible anxiety).
次要结局
- Associations between changes in anxiety and demographic variables(Up to 2 weeks)
- Efficacy of self-administered acupressure(Up to 2 weeks)
- Changes in anxiety-related symptoms(Up to 2 weeks)