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Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture

Primary Purpose

Patients Undergoing Puncture of the Bone Marrow

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Midazolam (sedative)
Piritramid (analgetic)
Cognitive exercises
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patients Undergoing Puncture of the Bone Marrow focused on measuring Bone marrow puncture, Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients scheduled for both first or repeated punction of the bone marrow Age between 18 and 85 years Written informed consent Exclusion Criteria: Contraindication for a punction of the bone marrow Administration of benzodiazepines or analgetic drugs prior to the bone marrow punction Known hypersensitivity to benzodiazepines or Piritramid Known contraindication to benzodiazepines (Myasthenia gravis in particular) or Piritramid (Pheochromocytoma or conditions affecting the consciousness) Poor general condition (ECOG Performance Status 3,4; Karnofsky Index < 50%) Addictive disorders Administration of antidepressive drugs Administration of drugs that potentially depress the respiratory function Severe cardio-circulatory or respiratory insufficiency, sleep apnea syndrome Known bradycardia History of syncope(s) of unclear etiology Pregnancy or lactation

Sites / Locations

  • Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 10, 2005
Last Updated
April 19, 2007
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT00188227
Brief Title
Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
Official Title
Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Technische Universität Dresden

4. Oversight

5. Study Description

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 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Undergoing Puncture of the Bone Marrow
Keywords
Bone marrow puncture, Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
748 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Midazolam (sedative)
Intervention Type
Drug
Intervention Name(s)
Piritramid (analgetic)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive exercises
Primary Outcome Measure Information:
Title
Reduction of pain and anxiety during and after the punction procedure
Title
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.
Secondary Outcome Measure Information:
Title
Duration of the effective pain reduction in each of the investigated groups
Title
Assessment of the quality of life in the period immediately after the bone marrow puncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for both first or repeated punction of the bone marrow Age between 18 and 85 years Written informed consent Exclusion Criteria: Contraindication for a punction of the bone marrow Administration of benzodiazepines or analgetic drugs prior to the bone marrow punction Known hypersensitivity to benzodiazepines or Piritramid Known contraindication to benzodiazepines (Myasthenia gravis in particular) or Piritramid (Pheochromocytoma or conditions affecting the consciousness) Poor general condition (ECOG Performance Status 3,4; Karnofsky Index < 50%) Addictive disorders Administration of antidepressive drugs Administration of drugs that potentially depress the respiratory function Severe cardio-circulatory or respiratory insufficiency, sleep apnea syndrome Known bradycardia History of syncope(s) of unclear etiology Pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Naumann, MD
Organizational Affiliation
University Clinic "Carl Gustav Carus" Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

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Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture

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