Postoperative PainNWPOPNCT00495807
Nurses' Negative Words and Postoperative Pain Management
A study testing No Words, Positive words and Partially Negative Words in people with Postoperative Pain, run by Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- No Words, Positive words and Partially Negative Words
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- Jun 2006to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chinese
- Abdominal Surgery
- > 18yr < 65yr
- Female
- Administration of postoperative analgesia
- Patient-controlled analgesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence on Pain Management of Nurses' Negative Words After Total Hysterectomy
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.
- Conditions
- Postoperative Pain
- Being tested
- No Words, Positive words, Partially Negative Words, Totally Negative Words
- Keywords
- Psychological Tests, Pain, Postoperative, Nurses
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No WordsBehavioural
Also called NW
Without any words was given during pain management
Positive wordsBehavioural
Also called PW
Positive words was given to PCA pain management patients at different time point,i.e. 3h, 6h, 12h and 18h.
Partially Negative WordsBehavioural
Also called PNW
Partially negative words was given during PCA pain management at different time point,i.e. 3h, 6h, 12h and 18h.
Totally Negative WordsBehavioural
Also called TNW
Totally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | No Words was delivered during the PCA management Receives: Behavioral: No Words |
| 2 | Active comparator | Positive words was delivered as a positive control group during the therapy of the pain with PCA Receives: Behavioral: Positive words |
| 3 | Active comparator | Partially negative words was delivered during the PCA pain management Receives: Behavioral: Partially Negative Words |
| 4 | Active comparator | Totally negative words was delivered during the PCA pain management Receives: Behavioral: Totally Negative Words |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale of Pain
Measured: 0h to 48h after operation
Secondary outcomes (1)
Morphine consumption; VAS sedation; VAS satisfaction; Side effects; Patient's overall conditions
Measured: 0-48h after surgeries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startJun 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Confidential Enquiry into Maternal and Child Health
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495807
- Sponsor's protocol ID
- NMU-2579-2FW
- Other IDs
- NMCH2006-012
- Acronym
- NWPOP
- Status last verified
- Apr 2008
- First submitted
- 2 Jul 2007
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence on Pain Management of Nurses' Negative Words After Total Hysterectomy
- ClinicalTrials.gov ID
- NCT00495807
- Acronym / sponsor ID
- NWPOP / NMU-2579-2FW
- Conditions
- Postoperative Pain
- Keywords
- Psychological Tests, Pain, Postoperative, Nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Confidential Enquiry into Maternal and Child Health
- Study start
- Jun 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Behavioral: No WordsNo Words was delivered during the PCA management |
| 2 | Active comparator | Behavioral: Positive wordsPositive words was delivered as a positive control group during the therapy of the pain with PCA |
| 3 | Active comparator | Behavioral: Partially Negative WordsPartially negative words was delivered during the PCA pain management |
| 4 | Active comparator | Behavioral: Totally Negative WordsTotally negative words was delivered during the PCA pain management |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chinese
- Abdominal Surgery
- > 18yr < 65yr
- Female
- Administration of postoperative analgesia
Key exclusion criteria (7 listed)
- With cardiac or/and pulmonary diseases
- Allergy to Opioids
- > 20% alteration in vital signs
- Unwilling to finish the follow-up process
- Respiratory depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No WordsAlso: NWWithout any words was given during pain management | Behavioural | 1 |
| Positive wordsAlso: PWPositive words was given to PCA pain management patients at different time point,i.e. 3h, 6h, 12h and 18h. | Behavioural | 2 |
| Partially Negative WordsAlso: PNWPartially negative words was given during PCA pain management at different time point,i.e. 3h, 6h, 12h and 18h. | Behavioural | 3 |
| Totally Negative WordsAlso: TNWTotally negative words was given during PCA pain management at different time points, i.e. 3h, 6h, 12h and 18h | Behavioural | 4 |
Primary outcome
Visual Analog Scale of Pain
Time frame: 0h to 48h after operation
1 secondary outcome
Morphine consumption; VAS sedation; VAS satisfaction; Side effects; Patient's overall conditions
Time frame: 0-48h after surgeries
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2008.
- Results publication: PubMed 18612266Wang 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.
Related trials for Postoperative Pain
Not yet recruitingObservational study
Impact of Parasternal and Rectointercostal Blocks on Extubation Time
Postoperative Pain, Extubation Time
RecruitingObservational study
Quality of Life and Pain After Appendectomy in Children
Chronic Pain, Postoperative, Quality of Life
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study chair
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Words, Positive words and Partially Negative Words in people with Postoperative Pain, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale of Pain (time frame: 0h to 48h after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00495807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2008.