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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00495807
Other study ID # NMU-2579-2FW
Secondary ID NMCH2006-012
Status Completed
Phase N/A
First received July 2, 2007
Last updated July 11, 2008
Start date June 2006
Est. completion date May 2007

Study information

Verified date April 2008
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeChina: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 64 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
No Words
Without any words was given during pain management
Positive words
Positive words was given to PCA pain management patients at different time point,i.e. 3h, 6h, 12h and 18h.
Partially Negative Words
Partially negative words was given during PCA pain management at different time point,i.e. 3h, 6h, 12h and 18h.
Totally Negative Words
Totally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h

Locations

Country Name City State
China Nanjing Maternal and Child Care Hospital Nanjing Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Nanjing Medical University Confidential Enquiry into Maternal and Child Health

Country where clinical trial is conducted

China, 

References & Publications (1)

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-Au — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale of Pain 0h to 48h after operation Yes
Secondary Morphine consumption; VAS sedation; VAS satisfaction; Side effects; Patient's overall conditions 0-48h after surgeries Yes
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