Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188227
Status:
COMPLETED
Last Update Posted:
2007-04-20
First Post:
2005-09-10
Brief Title:
Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
Status:
COMPLETED
Status Verified Date:
2005-09
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 investigate and compare the effects of three different methods for reducing pain and anxiety in adult patients undergoing puncture of the bone marrow The investigated methods are cognitive behavioural technique administration of a sedative drugMidazolam and administration of an analgetic drug Piritramidprior to the procedure Additionally there are two comparison groups in which the patients receive either placebo treatment or no treatment at all
Detailed Description:
The puncture of the bone marrow is a routine medical procedure which is often performed in the field of hematologyoncology When carefully and appropriately performed the puncture of the bone marrow has a very low rate of complications and is generally safe for the patient However it is an invasive and painful procedure associated with anxiety especially in patients undergoing repeated punctures Therefore an appropriate preparation of the patient for the puncture is essential in order to minimize the stress experienced during the procedure In this regard there are numbers of both pharmacological and non-pharmacological interventions in pedriatric patients aimed at reducing the punction related pain and anxiety in this patients Nevertheless an evidence based approach for the pretreatment of the patients is yet to be established The aim of this study is to investigate three different methods for reducing the pain and anxiety associated with the puncture of the bone marrow in adult patients Two of the of the investigated methods involve pretreatment of the patients with pharmacological agents sedative drug or analgetic drug whereas the third method involves cognitive behavioural pretreatment in form of an audio material The patients in the control group receive placebo injections
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