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CompletedNCT00495807NWPOPUpdated Jul 15, 2008

Nurses' Negative Words and Postoperative Pain Management

An interventional study of No Words and Positive words in Postoperative Pain, sponsored by Nanjing Medical University. Completed at 1 site in China. Open to female participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2008-07-15.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
1,500
Allocation
Randomized
Ages
19 Years to 64 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Postoperative Pain

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Keywords

  • Psychological Tests
  • Pain, Postoperative
  • Nurses
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 1,500 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Chinese
  • Abdominal Surgery
  • > 18yr \< 65yr
  • Female
  • Administration of postoperative analgesia
  • Patient-controlled analgesia

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,500 participants (actual)

Study arms

  • No intervention
    1

    No Words was delivered during the PCA management

    Behavioral: No Words

  • Active comparator
    2

    Positive words was delivered as a positive control group during the therapy of the pain with PCA

    Behavioral: Positive words

  • Active comparator
    3

    Partially negative words was delivered during the PCA pain management

    Behavioral: Partially Negative Words

  • Active comparator
    4

    Totally negative words was delivered during the PCA pain management

    Behavioral: Totally Negative Words

Interventions

  • BehavioralNo Words

    Without any words was given during pain management

    Also known as: NW

  • BehavioralPositive words

    Positive words was given to PCA pain management patients at different time point,i.e. 3h, 6h, 12h and 18h.

    Also known as: PW

  • BehavioralPartially Negative Words

    Partially negative words was given during PCA pain management at different time point,i.e. 3h, 6h, 12h and 18h.

    Also known as: PNW

  • BehavioralTotally Negative Words

    Totally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h

    Also known as: TNW

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What researchers measure

Primary outcomes

  1. Visual Analog Scale of Pain

    Time frame: 0h to 48h after operation

Secondary outcomes

  1. Morphine consumption; VAS sedation; VAS satisfaction; Side effects; Patient's overall conditions

    Time frame: 0-48h after surgeries

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Study locations

1 site
  • Nanjing Maternal and Child Care Hospital
    Nanjing, Jiangsu 210004, China
08

References and documents

Publications

  • 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. PubMed 18612266 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00495807
Lead sponsor
Nanjing Medical University
Collaborators
Confidential Enquiry into Maternal and Child Health
First posted
Jul 3, 2007
Start date
Jun 2006
Primary completion
May 2007
Completion
May 2007
Last update
Jul 15, 2008

Study contacts

XiaoFeng Shen, MD
study chair · Nanjing Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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