Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT01569269
Status:
COMPLETED
Last Update Posted:
2012-04-03
First Post:
2012-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Reiki, Yoga, Meditation, on the Physical and Psychological Symptoms of Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
George Mason University
Organization:
Study Overview
Official Title:
A Randomized, Four-Arm Study Comparing Reiki, Yoga, Meditation, or Patient Education Group for Addressing Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test whether people with symptoms of chemotherapy-induced peripheral neuropathy (CIPN) receive physical or psychological benefits from participating in a six-week Reiki, Yoga, Meditation, or Educational experience.
Detailed Description:
Chemotherapy-induced peripheral neuropathy (CIPN) is a side effect that occurs with many of the most common chemotherapeutic agents used to treat cancer. Typically, CIPN is experienced as tingling, burning, numbness, or pain in the upper and lower extremities and other parts of the body. Severity of symptoms can range from bothersome to disabling and can have profoundly negative effects on quality of life. Although the specific incidence or prevalence of CIPN is unknown, it is generally estimated at 30 to 40 percent in patients who have received the classes of chemotherapeutic agents used to treat breast, colon, and lung, cancers, and lymphomas. There are no treatments or drugs that consistently ameliorate or lead to the reversal of CIPN symptoms.Typically, symptoms of CIPN are considered along with other pain symptoms and treated with opioids and analgesics. Additionally, the prescription of anticonvulsant medications and tricyclic antidepressants can help alleviate neuropathic pain. While these strategies can provide relief from cancer-related pain, they often yield limited results for symptoms of CIPN. With few allopathic treatment alternatives for attenuating the symptoms of CIPN, people living with these symptoms have few options other than to endure them.
Unlike treatments based upon nociceptive and neuropathic models of pain that regard the pain response as the outcome of a finite and mechanistic chain of biochemical events, complementary treatments acknowledge the interpenetrating nature of the relationships between body, mind, and spirit. Typically, complementary or integrative health strategies incorporate psychological, emotional, and spiritual elements along with biochemical strategies when addressing pain. Of particular interest in the proposed pilot study are complementary techniques that include Yoga, Meditation, and Reiki.
Utilizing a pretest-posttest control group design with random assignment, this four-arm experimental pilot study will be undertaken to determine the feasibility of three complementary approaches in reducing the signs and symptoms of CIPN. This design was chosen for its ability to support causal inference while managing threats to internal and external design validity. The use of random assignment in the development of intervention and comparison groups will strengthen the ability of this design to manage threats to internal validity more efficiently. This pilot study involves the collection of quantitative data from self-administered instruments that have been designed to measure health related quality of life, symptoms of neurotoxicity, psychological distress, and mindfulness.
Unlike treatments based upon nociceptive and neuropathic models of pain that regard the pain response as the outcome of a finite and mechanistic chain of biochemical events, complementary treatments acknowledge the interpenetrating nature of the relationships between body, mind, and spirit. Typically, complementary or integrative health strategies incorporate psychological, emotional, and spiritual elements along with biochemical strategies when addressing pain. Of particular interest in the proposed pilot study are complementary techniques that include Yoga, Meditation, and Reiki.
Utilizing a pretest-posttest control group design with random assignment, this four-arm experimental pilot study will be undertaken to determine the feasibility of three complementary approaches in reducing the signs and symptoms of CIPN. This design was chosen for its ability to support causal inference while managing threats to internal and external design validity. The use of random assignment in the development of intervention and comparison groups will strengthen the ability of this design to manage threats to internal validity more efficiently. This pilot study involves the collection of quantitative data from self-administered instruments that have been designed to measure health related quality of life, symptoms of neurotoxicity, psychological distress, and mindfulness.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: