Nurses' Negative Words and Postoperative Pain Management (NWPOP)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
No Words
Positive words
Partially Negative Words
Totally Negative Words
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring Psychological Tests, Pain, Postoperative, Nurses
Eligibility Criteria
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
Sites / Locations
- Nanjing Maternal and Child Care Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
No Words was delivered during the PCA management
Positive words was delivered as a positive control group during the therapy of the pain with PCA
Partially negative words was delivered during the PCA pain management
Totally negative words was delivered during the PCA pain management
Outcomes
Primary Outcome Measures
Visual Analog Scale of Pain
Secondary Outcome Measures
Morphine consumption; VAS sedation; VAS satisfaction; Side effects; Patient's overall conditions
Full Information
NCT ID
NCT00495807
First Posted
July 2, 2007
Last Updated
July 11, 2008
Sponsor
Nanjing Medical University
Collaborators
Confidential Enquiry into Maternal and Child Health
1. Study Identification
Unique Protocol Identification Number
NCT00495807
Brief Title
Nurses' Negative Words and Postoperative Pain Management
Acronym
NWPOP
Official Title
Influence on Pain Management of Nurses' Negative Words After Total Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nanjing Medical University
Collaborators
Confidential Enquiry into Maternal and Child Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Psychological Tests, Pain, Postoperative, Nurses
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
No Words was delivered during the PCA management
Arm Title
2
Arm Type
Active Comparator
Arm Description
Positive words was delivered as a positive control group during the therapy of the pain with PCA
Arm Title
3
Arm Type
Active Comparator
Arm Description
Partially negative words was delivered during the PCA pain management
Arm Title
4
Arm Type
Active Comparator
Arm Description
Totally negative words was delivered during the PCA pain management
Intervention Type
Behavioral
Intervention Name(s)
No Words
Other Intervention Name(s)
NW
Intervention Description
Without any words was given during pain management
Intervention Type
Behavioral
Intervention Name(s)
Positive words
Other Intervention Name(s)
PW
Intervention Description
Positive words was given to PCA pain management patients at different time point,i.e. 3h, 6h, 12h and 18h.
Intervention Type
Behavioral
Intervention Name(s)
Partially Negative Words
Other Intervention Name(s)
PNW
Intervention Description
Partially negative words was given during PCA pain management at different time point,i.e. 3h, 6h, 12h and 18h.
Intervention Type
Behavioral
Intervention Name(s)
Totally Negative Words
Other Intervention Name(s)
TNW
Intervention Description
Totally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h
Primary Outcome Measure Information:
Title
Visual Analog Scale of Pain
Time Frame
0h to 48h after operation
Secondary Outcome Measure Information:
Title
Morphine consumption; VAS sedation; VAS satisfaction; Side effects; Patient's overall conditions
Time Frame
0-48h after surgeries
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Maternal and Child Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
18612266
Citation
Wang F, Shen X, Xu S, Liu Y, Ma L, Zhao Q, Fu D, Pan Q, Feng S, Li X. Negative words on surgical wards result in therapeutic failure of patient-controlled analgesia and further release of cortisol after abdominal surgeries. Minerva Anestesiol. 2008 Jul-Aug;74(7-8):353-65.
Results Reference
result
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Nurses' Negative Words and Postoperative Pain Management
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