Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
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 drug(Midazolam) and administration of an analgetic drug (Piritramid)prior to the procedure. Additionally, there are two comparison groups in which the patients receive either placebo treatment or no treatment at all.
Patients Undergoing Puncture of the Bone Marrow
Drug: Midazolam (sedative)
Drug: Piritramid (analgetic)
Behavioral: Cognitive exercises
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture|
- Reduction of pain and anxiety during and after the punction procedure
- Comparison of the efficacy of the three investigated methods to the placebo group, as well as to the group not receiving any pretreatment at all.
- Duration of the effective pain reduction in each of the investigated groups
- Assessment of the quality of life in the period immediately after the bone marrow puncture
|Study Start Date:||September 2001|
|Estimated Study Completion Date:||November 2003|
The puncture of the bone marrow is a routine medical procedure which is often performed in the field of hematology/oncology. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00188227
|Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus|
|Dresden, Sachsen, Germany, 01307|
|Principal Investigator:||Ralph Naumann, MD||University Clinic "Carl Gustav Carus" Dresden|