Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087841
Status:
COMPLETED
Last Update Posted:
2008-01-17
First Post:
2004-07-14
Brief Title:
Self-Hypnotic Relaxation Therapy During Invasive Procedures
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Midcareer Development of Nonpharmacologic Analgesia
Status:
COMPLETED
Status Verified Date:
2008-01
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 determine the effectiveness of self-hypnotic relaxation on mental and physical distress during and after tumor treatment procedures
Detailed Description:
Pain relievers and sedatives may have limited effectiveness and serious side effects when given to alleviate distress during minimally invasive surgical procedures Unabated distress may interfere with the ongoing procedure and may negatively impact future interventions
Studies have shown that nonpharmacologic analgesia in the form of self-hypnotic relaxation during invasive medical procedures significantly reduces patients pain anxiety drug use and number of complications The long-term goal of this study is to determine whether self-hypnotic relaxation therapy can be a safe and practical method for reducing cognitive and physiologic distress associated with invasive procedures
Participants in this study will be randomly assigned to one of three groups a standard care group an empathic control group and a self-hypnotic relaxation group The emphatic control group will meet with a clinician who will offer encouragement and support The group assigned to self-hypnotic relaxation will read a standardized script prior to procedure Self-report questionnaires will be used to assess pain and anxiety
Studies have shown that nonpharmacologic analgesia in the form of self-hypnotic relaxation during invasive medical procedures significantly reduces patients pain anxiety drug use and number of complications The long-term goal of this study is to determine whether self-hypnotic relaxation therapy can be a safe and practical method for reducing cognitive and physiologic distress associated with invasive procedures
Participants in this study will be randomly assigned to one of three groups a standard care group an empathic control group and a self-hypnotic relaxation group The emphatic control group will meet with a clinician who will offer encouragement and support The group assigned to self-hypnotic relaxation will read a standardized script prior to procedure Self-report questionnaires will be used to assess pain and anxiety
Study Oversight
Has Oversight DMC:
None
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?:
None