Nurse's RoleNCT04918485
Effect of Preoperative Psychological Intervention on the Degree of Cooperation During Tracheal Catheter Extubation in Patients
A study testing preoperative psychological intervention in people with Nurse's Role, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The patients in the experimental group received the relevant knowledge education in the recovery period 30 minutes before anesthesia. The operation time, anesthesia time, cooperation degree score, total cooperation rate and patient satisfaction were observed and recorded. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Nurse's Role
- What is being tested?
- preoperative psychological intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2020
- 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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- the patients who will undergo cholecystectomy surgery
Who cannot join
- the patients who can not well communicate
Trial locations and contacts
1 site in 1 country.
China1 site
2nd affiliated hospital, school of medicine, Zhejiang University
Hangzhou, Zhengjiang, 310000
About this study
Official title: Effect of Preoperative Psychological Intervention on the Degree of Cooperation During Tracheal Catheter Extubation in Patients Under General Anesthesia During Awakening Period
The patients in the experimental group received the relevant knowledge education in the recovery period 30 minutes before anesthesia. The operation time, anesthesia time, cooperation degree score, total cooperation rate and patient satisfaction were observed and recorded. Results: there was no significant difference in operation time and anesthesia time between the experimental group and the control group (P < 0.05). The percentage of patients in the experimental group was 20.12% and 70.89% respectively, while that in the control group was 40.32% and 20.73% respectively (P < 0.05). The total cooperation rate was 95.00% in the experimental group and 77.00% in the control group. There was significant difference between the two groups (P < 0.05). The satisfaction of patients in the experimental group was 95%. 65% of the patients in the control group were satisfied (P < 0.05). Conclusion: preoperative psychological intervention for patients with general anesthesia and endotracheal intubation can significantly reduce the restlessness and uncooperative phenomenon during extubation, and improve the cooperation rate and satisfaction of patients.
- Conditions
- Nurse's Role
- Being tested
- preoperative psychological intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative psychological interventionOther
including closing the relationship between nurse and patient , knowledge education,
| Study group | Role | What they receive |
|---|---|---|
| the experimental group received psychological intervention | Experimental | Not described Receives: Other: preoperative psychological intervention |
| the control group receive normal process before surgery | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total cooperation rate
The total cooperation rate was 95.00% in the experimental group and 77.00% in the control group.
Measured: through study completion, an average of half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Sep 2020
- Primary completion2 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918485
- Sponsor's protocol ID
- SAHZhejiangUChenshuyi
- Status last verified
- Jan 2021
- First submitted
- 2 Jun 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Psychological Intervention on the Degree of Cooperation During Tracheal Catheter Extubation in Patients Under General Anesthesia During Awakening Period
- ClinicalTrials.gov ID
- NCT04918485
- Acronym / sponsor ID
- SAHZhejiangUChenshuyi
- Conditions
- Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 Jun 2021 (actual)
- 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.
The patients in the experimental group received the relevant knowledge education in the recovery period 30 minutes before anesthesia. The operation time, anesthesia time, cooperation degree score, total cooperation rate and patient satisfaction were observed and recorded. Results: there was no significant difference in operation time and anesthesia time between the experimental group and the control group (P < 0.05). The percentage of patients in the experimental group was 20.12% and 70.89% respectively, while that in the control group was 40.32% and 20.73% respectively (P < 0.05). The total cooperation rate was 95.00% in the experimental group and 77.00% in the control group. There was significant difference between the two groups (P < 0.05). The satisfaction of patients in the experimental group was 95%. 65% of the patients in the control group were satisfied (P < 0.05). Conclusion: preoperative psychological intervention for patients with general anesthesia and endotracheal intubation can significantly reduce the restlessness and uncooperative phenomenon during extubation, and improve the cooperation rate and satisfaction of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group received psychological intervention | Experimental | Other: preoperative psychological intervention |
| the control group receive normal process before surgery | No intervention | – |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the patients who will undergo cholecystectomy surgery
Key exclusion criteria (1 listed)
- the patients who can not well communicate
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 |
|---|---|---|
| preoperative psychological interventionincluding closing the relationship between nurse and patient , knowledge education, | Other | the experimental group received psychological intervention |
Primary outcome
The total cooperation rate
Time frame: through study completion, an average of half a year
The total cooperation rate was 95.00% in the experimental group and 77.00% in the control group.
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 8 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative psychological intervention in people with Nurse's Role, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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 8 Jun 2021. 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?
The total cooperation rate (time frame: through study completion, an average of half a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2021.