- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00495807
Nurses' Negative Words and Postoperative Pain Management (NWPOP)
July 11, 2008 updated by: Nanjing Medical University
Influence on Pain Management of Nurses' Negative Words After Total Hysterectomy
Psychological implications expressed pivotal effects on daily activities.
Postoperative pain management is always encountered varying influence from the ambience of surgical wards, especially the nurses.
We hypothesized that nurses' negative or positive words would produce unexpected role in pain management, which might be a strong factor resulting in the failure of postoperative analgesia.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210004
- Nanjing Maternal and Child Care Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Chinese
- Abdominal Surgery
- > 18yr < 65yr
- Female
- Administration of postoperative analgesia
- Patient-controlled analgesia
Exclusion Criteria:
- With cardiac or/and pulmonary diseases
- Allergy to Opioids
- > 20% alteration in vital signs
- Unwilling to finish the follow-up process
- Respiratory depression
- > = 65yr = < 18yr
- Non-Chinese
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 1
No Words was delivered during the PCA management
|
Without any words was given during pain management
Other Names:
|
|
Active Comparator: 2
Positive words was delivered as a positive control group during the therapy of the pain with PCA
|
Positive words was given to PCA pain management patients at different time point,i.e.
3h, 6h, 12h and 18h.
Other Names:
|
|
Active Comparator: 3
Partially negative words was delivered during the PCA pain management
|
Partially negative words was given during PCA pain management at different time point,i.e.
3h, 6h, 12h and 18h.
Other Names:
|
|
Active Comparator: 4
Totally negative words was delivered during the PCA pain management
|
Totally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual Analog Scale of Pain
Time Frame: 0h to 48h after operation
|
0h to 48h after operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Morphine consumption; VAS sedation; VAS satisfaction; Side effects; Patient's overall conditions
Time Frame: 0-48h after surgeries
|
0-48h after surgeries
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
July 2, 2007
First Submitted That Met QC Criteria
July 2, 2007
First Posted (Estimate)
July 3, 2007
Study Record Updates
Last Update Posted (Estimate)
July 15, 2008
Last Update Submitted That Met QC Criteria
July 11, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMU-2579-2FW
- NMCH2006-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.