Back to results

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

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Psychological Tests, Pain, Postoperative, Nurses

Eligibility Criteria

19 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Arm Label

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

Arm Type

No Intervention

Arm Description

No Words was delivered during the PCA management

Arm Title

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

Arm Type

Active Comparator

Arm Description

Partially negative words was delivered during the PCA pain management

Arm Title

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)

Intervention Description

Without any words was given during pain management

Intervention Type

Behavioral

Intervention Name(s)

Positive words

Other Intervention Name(s)

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

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

Learn more about this trial

Nurses' Negative Words and Postoperative Pain Management

We'll reach out to this number within 24 hrs