Postoperative ComplicationsNCT06757023
A Clinical Follow-up Study on the Efficacy of Thumbtack Needle for Postoperative Sleep and Recovery Treatment
An observational study of Postoperative Complications and Postoperative Pain, run by The First Affiliated Hospital of Xiamen University at 2 sites in China.
Trial summary
To understand the impact of thumb-tack needle therapy on postoperative sleep and recovery in patients who have undergone general anesthesia, and to explore the clinical significance of thumb-tack needle therapy in improving postoperative sleep quality, preventing postoperative sleep disorders, and promoting… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Postoperative Complications, Postoperative Pain, Acupuncture
- How many people
- 110 participants
- Where
- 2 sitesChina
- Study dates
- 13 Nov 2024to 13 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing breast cancer surgery with general anesthesia in the hospital
Who may be able to join
- Patients undergoing breast cancer surgery with general anesthesia in the hospital;
- American Society of Anesthesiologists (ASA) classification I-II;
- Women aged 18-55 years;
- No history of chronic insomnia;
- Individuals who have not taken sedative-hypnotic drugs within the past month.
Who cannot join
- Those who do not meet the aforementioned inclusion criteria;
- A history of severe heart, brain, lung, or kidney diseases (such as acute coronary syndrome (ACS), severe heart failure classified as NYHA Class III or IV, severe arrhythmias, severe valvular disease; acute aortic disease, and severe peripheral vascular disease, etc.), or poor physical condition (including reduced exercise tolerance, multi-organ dysfunction, malnutrition, etc.);
- A history of sleep disorders and psychiatric history;
- Inability to receive thumb-tack needle treatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Bin Yang doctor, 86+1385998603, yangbin4332@outlook.com
- Recruiting
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Bin Yang doctor, +86 13950374558, 2389899106@qq.com
About this study
To understand the impact of thumb-tack needle therapy on postoperative sleep and recovery in patients who have undergone general anesthesia, and to explore the clinical significance of thumb-tack needle therapy in improving postoperative sleep quality, preventing postoperative sleep disorders, and promoting postoperative recovery
- Conditions
- Postoperative Complications, Postoperative Pain, Acupuncture
- Medical subject headings
- Postoperative Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing breast cancer surgery with general anesthesia in the hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index(PSQI)
Total scores range from 0 to 21, with higher scores indicating worse sleep quality.
Measured: 1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.
Secondary outcomes (1)
Later Recovery evaluated by QoR-40 questionnaire
The maximum total score is 200, with higher scores indicating better recovery quality
Measured: QoR-40 score on the third day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start13 Nov 2024
- Primary completion13 Oct 2026 (estimated)
- Study completion13 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Bin, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757023
- Sponsor's protocol ID
- FirstAHXiamenU-YB-3
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Follow-up Study on the Efficacy of Thumbtack Needle for Postoperative Sleep and Recovery Treatment
- ClinicalTrials.gov ID
- NCT06757023
- Acronym / sponsor ID
- FirstAHXiamenU-YB-3
- Conditions
- Postoperative Complications, Postoperative Pain, Acupuncture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 13 Oct 2026 (estimated)
- Study completion
- 13 Nov 2026 (estimated)
- First posted
- 3 Jan 2025 (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.
To understand the impact of thumb-tack needle therapy on postoperative sleep and recovery in patients who have undergone general anesthesia, and to explore the clinical significance of thumb-tack needle therapy in improving postoperative sleep quality, preventing postoperative sleep disorders, and promoting postoperative recovery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing breast cancer surgery with general anesthesia in the hospital | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing breast cancer surgery with general anesthesia in the hospital
Key inclusion criteria (5 listed)
- Patients undergoing breast cancer surgery with general anesthesia in the hospital;
- American Society of Anesthesiologists (ASA) classification I-II;
- Women aged 18-55 years;
- No history of chronic insomnia;
- Individuals who have not taken sedative-hypnotic drugs within the past month.
Key exclusion criteria (4 listed)
- Those who do not meet the aforementioned inclusion criteria;
- A history of severe heart, brain, lung, or kidney diseases (such as acute coronary syndrome (ACS), severe heart failure classified as NYHA Class III or IV, severe arrhythmias, severe valvular disease; acute aortic disease, and severe peripheral vascular disease, etc.), or poor physical condition (including reduced exercise tolerance, multi-organ dysfunction, malnutrition, etc.);
- A history of sleep disorders and psychiatric history;
- Inability to receive thumb-tack needle treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pittsburgh sleep quality index(PSQI)
Time frame: 1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.
Total scores range from 0 to 21, with higher scores indicating worse sleep quality.
1 secondary outcome
Later Recovery evaluated by QoR-40 questionnaire
Time frame: QoR-40 score on the third day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Postoperative Pain, run by The First Affiliated Hospital of Xiamen University at 2 sites 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Yang doctor (1385998603, yangbin4332@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index(PSQI) (time frame: 1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.). 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 3 Jan 2025.