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Nurses' Negative Words and Postoperative Pain Management (NWPOP)

This study has been completed.
Sponsor:
Collaborator:
Confidential Enquiry into Maternal and Child Health
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00495807
First received: July 2, 2007
Last updated: July 11, 2008
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Pain
 Behavioral: No Words
Behavioral: Positive words
Behavioral: Partially Negative Words
Behavioral: Totally Negative Words

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence on Pain Management of Nurses' Negative Words After Total Hysterectomy

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Visual Analog Scale of Pain [ Time Frame: 0h to 48h after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Morphine consumption; VAS sedation; VAS satisfaction; Side effects; Patient's overall conditions [ Time Frame: 0-48h after surgeries ] [ Designated as safety issue: Yes ]

Enrollment: 1500
Study Start Date: June 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
No Words was delivered during the PCA management
 Behavioral: No Words
Without any words was given during pain management
Other Name: NW
Active Comparator: 2
Positive words was delivered as a positive control group during the therapy of the pain with PCA
 Behavioral: Positive words
Positive words was given to PCA pain management patients at different time point,i.e. 3h, 6h, 12h and 18h.
Other Name: PW
Active Comparator: 3
Partially negative words was delivered during the PCA pain management
 Behavioral: Partially Negative Words
Partially negative words was given during PCA pain management at different time point,i.e. 3h, 6h, 12h and 18h.
Other Name: PNW
Active Comparator: 4
Totally negative words was delivered during the PCA pain management
 Behavioral: Totally Negative Words
Totally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h
Other Name: TNW

  Eligibility

Ages Eligible for Study:   19 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495807

Locations
China, Jiangsu
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Confidential Enquiry into Maternal and Child Health
Investigators
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
  More Information

Publications:

Responsible Party: XiaoFeng Shen, Nanjing Maternal and Child Health Hospital
ClinicalTrials.gov Identifier: NCT00495807     History of Changes
Other Study ID Numbers: NMU-2579-2FW, NMCH2006-012
Study First Received: July 2, 2007
Last Updated: July 11, 2008
Health Authority: China: Ethics Committee
China: Ministry of Health

Keywords provided by Nanjing Medical University:
Psychological Tests
Pain, Postoperative
Nurses

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013