Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608175
Status:
UNKNOWN
Last Update Posted:
2020-10-29
First Post:
2020-10-09
Brief Title:
The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery
Sponsor:
University Ramon Llull
Organization:
University Ramon Llull
Study Overview
Official Title:
The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery Pragmatic Randomized Control Trial
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
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:
Background Breast cancer is one of the most prevalent cancers worldwide Fortunately survival has improved in recent years thanks to its early detection and curative treatments such as mastectomy However this medical procedure is associated with a range of unwanted effects such as postoperative pain and anxiety Some studies have reported that acupuncture could be an effective treatment to control these types of symptoms although only few studies have been conducted on women undergoing mastectomy
Methods This is a pragmatic randomized controlled trial with blind assessors The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona Spain A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures or standard care procedures alone The main outcome pain will be assessed after the surgical intervention and 4 10 and 30 days later using the numerical rating scale Secondary outcomes include anxiety use of analgesics nausea adverse effects and surgical complications
Discussion Acupuncture is a low-cost non-pharmacological strategy This study will help to clarify its possible role in controlling post-mastectomy adverse effects
Methods This is a pragmatic randomized controlled trial with blind assessors The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona Spain A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures or standard care procedures alone The main outcome pain will be assessed after the surgical intervention and 4 10 and 30 days later using the numerical rating scale Secondary outcomes include anxiety use of analgesics nausea adverse effects and surgical complications
Discussion Acupuncture is a low-cost non-pharmacological strategy This study will help to clarify its possible role in controlling post-mastectomy adverse effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 201959-FIS-HUSC | OTHER | Hospital Sagrado Corazón | None |