Postoperative Sleep DisturbancesPASA-VATSNCT07662733
Effectiveness of Perioperative Percutaneous Acupuncture on Postoperative Sleep Disturbances and Chronic Pain in Patients Undergoing Video-Assisted Thoracoscopic Lung Cancer Resection: A Prospective, Randomized, Single-Blind, Superiority Controlled Trial
A study testing Percutaneous Acupoint Acupuncture in people with Postoperative Sleep Disturbances and Chronic Post-surgical Pain, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
This study evaluates whether acupuncture at specific body points before and after surgery can improve sleep quality and reduce long-term postoperative pain in patients undergoing video-assisted thoracoscopic lung cancer resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Sleep Disturbances, Chronic Post-surgical Pain
- What is being tested?
- Percutaneous Acupoint Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 2 sitesChina
- Study dates
- 13 Jun 2025to 29 Nov 2027
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-75 years scheduled for elective video-assisted thoracoscopic surgery (VATS) for lung cancer resection.
- American Society of Anesthesiologists (ASA) physical status classification I-II.
- Body Mass Index (BMI) between 18.5 and 28 kg/m².
- Clinical tumor stage according to the 8th edition of the AJCC/UICC TNM Classification: cTis-3N0-1M0.
- Mentally competent, able to understand and correctly use the Numeric Rating Scale (NRS) for pain assessment.
- Willing and able to provide written informed consent prior to study participation.
Who cannot join
- Critical preoperative condition or inability to cooperate.
- History of sleep apnea or moderate to severe snoring.
- Pittsburgh Sleep Quality Index (PSQI) ≥7 or Athens Insomnia Scale (AIS) score ≥6.
- Implanted cardiac pacemaker, preoperative sinus bradycardia (heart rate ≤50 bpm), sinoatrial node disease, or second-/third-degree atrioventricular block.
- Long-term use of anticonvulsants, antidepressants, or other psychotropic medications.
- Known hypersensitivity or allergy to the study materials (needles/devices) or related medications.
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- Severe cardiac, hepatic, or renal dysfunction.
- Participation in another clinical trial within the past 3 months.
- Hearing and/or language communication impairment.
- Pregnancy or breastfeeding.
- Fever (body temperature ≥38.5°C) or clinical evidence of infection (hematological, radiological, and/or microbiological) prior to surgery.
- Planned reoperation, or anticipated postoperative recurrence, severe complications, or critical illness requiring exclusion from follow-up.
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
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 201620
Na li Huang, PhD, +86-18001780050, Honilla@163.com
- Recruiting
Shanghai First People's Hospital
Shanghai
Na li Huang, PhD, +86-18001780050, Honilla@163.com
About this study
Official title: Effectiveness of Perioperative Percutaneous Acupoint Acupuncture on Postoperative Sleep Disturbances in Patients Undergoing Video-Assisted Thoracoscopic Lung Cancer Resection: A Prospective, Randomized, Single-Blind, Superiority Controlled Trial
This study evaluates whether acupuncture at specific body points before and after surgery can improve sleep quality and reduce long-term postoperative pain in patients undergoing video-assisted thoracoscopic lung cancer resection. Eligible adult patients will be randomly assigned to receive either true acupuncture or sham (placebo) acupuncture in addition to standard care. Chronic pain will be assessed during hospital stay and up to 6 months after surgery.
- Being tested
- Percutaneous Acupoint Acupuncture, Sham Acupuncture
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Acupoint AcupunctureOther
Participants in the acupuncture group will receive manual acupuncture at four bilateral acupoints: Heart 7 (HT7 Shenmen), Pericardium 6 (PC6 Neiguan), Stomach 36 (ST36 Zusanli), and Kidney 6 (KI6 Zhaohai). Acupuncture will be performed on the night before surgery, on the night of the day of surgery, and on the first postoperative night (total of 3 sessions). Sterile disposable stainless steel needles (0.25 mm × 40 mm) will be inserted to a depth of 15-25 mm depending on location, with gentle lifting-thrusting and twisting until "Deqi" sensation (aching, heaviness, or tingling) is obtained. Needles will be retained for 30 minutes, during which manual stimulation will be applied every 10 minutes. No electrical stimulation will be used. Standard perioperative care will be provided to all participants.
Sham AcupunctureOther
Participants in the sham acupuncture group will undergo a placebo procedure using non-penetrating sham needles (e.g., Streitberger or similar non-skin-piercing placebo needle) applied at the same acupoints (bilateral HT7, PC6, ST36, KI6) and on the same schedule (the night before surgery, the night of surgery day, and postoperative day 1; total of 3 sessions). The sham needle tip retracts into the base upon contact with the skin, producing a tactile sensation without skin penetration or Deqi. The device will be left in place for 30 minutes without manipulation, mimicking the true acupuncture procedure in appearance and duration. Standard perioperative care will be provided to all participants.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | Experimental | Manual acupuncture at HT7, PC6, ST36, KI6 bilaterally before and after surgery; needles retained 30 min with deqi sensation. Receives: Other: Percutaneous Acupoint Acupuncture |
| Sham Acupuncture Group | Placebo comparator | Non-penetrating placebo needle applied at same acupoints (HT7, PC6, ST36, KI6) with identical procedure and duration; no skin penetration or deqi. Receives: Other: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Sleep Disturbance as Assessed by the Athens Insomnia Scale (AIS)
AIS is an 8-item self-report scale. A total score ≥6 indicates clinically significant insomnia/sleep disturbance. Higher scores indicate worse sleep quality.
Measured: Postoperative days 1, 2, and at hospital discharge (day 3-5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start13 Jun 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion29 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sleep DisturbancesStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIna Huang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662733
- Sponsor's protocol ID
- [2026]No.319
- Other IDs
- Yuan Lun Kuai 【2026】No.319
- Acronym
- PASA-VATS
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Perioperative Percutaneous Acupoint Acupuncture on Postoperative Sleep Disturbances in Patients Undergoing Video-Assisted Thoracoscopic Lung Cancer Resection: A Prospective, Randomized, Single-Blind, Superiority Controlled Trial
- ClinicalTrials.gov ID
- NCT07662733
- Acronym / sponsor ID
- PASA-VATS / [2026]No.319
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 29 Nov 2027 (estimated)
- First posted
- 23 Jun 2026 (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.
This study evaluates whether acupuncture at specific body points before and after surgery can improve sleep quality and reduce long-term postoperative pain in patients undergoing video-assisted thoracoscopic lung cancer resection. Eligible adult patients will be randomly assigned to receive either true acupuncture or sham (placebo) acupuncture in addition to standard care. Chronic pain will be assessed during hospital stay and up to 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Experimental | Other: Percutaneous Acupoint AcupunctureManual acupuncture at HT7, PC6, ST36, KI6 bilaterally before and after surgery; needles retained 30 min with deqi sensation. |
| Sham Acupuncture Group | Placebo comparator | Other: Sham AcupunctureNon-penetrating placebo needle applied at same acupoints (HT7, PC6, ST36, KI6) with identical procedure and duration; no skin penetration or deqi. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18-75 years scheduled for elective video-assisted thoracoscopic surgery (VATS) for lung cancer resection.
- American Society of Anesthesiologists (ASA) physical status classification I-II.
- Body Mass Index (BMI) between 18.5 and 28 kg/m².
- Clinical tumor stage according to the 8th edition of the AJCC/UICC TNM Classification: cTis-3N0-1M0.
- Mentally competent, able to understand and correctly use the Numeric Rating Scale (NRS) for pain assessment.
Key exclusion criteria (12 listed)
- Critical preoperative condition or inability to cooperate.
- History of sleep apnea or moderate to severe snoring.
- Pittsburgh Sleep Quality Index (PSQI) ≥7 or Athens Insomnia Scale (AIS) score ≥6.
- Implanted cardiac pacemaker, preoperative sinus bradycardia (heart rate ≤50 bpm), sinoatrial node disease, or second-/third-degree atrioventricular block.
- Long-term use of anticonvulsants, antidepressants, or other psychotropic medications.
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 |
|---|---|---|
| Percutaneous Acupoint AcupunctureParticipants in the acupuncture group will receive manual acupuncture at four bilateral acupoints: Heart 7 (HT7 Shenmen), Pericardium 6 (PC6 Neiguan), Stomach 36 (ST36 Zusanli), and Kidney 6 (KI6 Zhaohai). Acupuncture will be performed on the night before surgery, on the night of the day of surgery, and on the first postoperative night (total of 3 sessions). Sterile disposable stainless steel needles (0.25 mm × 40 mm) will be inserted to a depth of 15-25 mm depending on location, with gentle lifting-thrusting and twisting until "Deqi" sensation (aching, heaviness, or tingling) is obtained. Needles will be retained for 30 minutes, during which manual stimulation will be applied every 10 minutes. No electrical stimulation will be used. Standard perioperative care will be provided to all participants. | Other | Acupuncture Group |
| Sham AcupunctureParticipants in the sham acupuncture group will undergo a placebo procedure using non-penetrating sham needles (e.g., Streitberger or similar non-skin-piercing placebo needle) applied at the same acupoints (bilateral HT7, PC6, ST36, KI6) and on the same schedule (the night before surgery, the night of surgery day, and postoperative day 1; total of 3 sessions). The sham needle tip retracts into the base upon contact with the skin, producing a tactile sensation without skin penetration or Deqi. The device will be left in place for 30 minutes without manipulation, mimicking the true acupuncture procedure in appearance and duration. Standard perioperative care will be provided to all participants. | Other | Sham Acupuncture Group |
Primary outcome
Incidence of Postoperative Sleep Disturbance as Assessed by the Athens Insomnia Scale (AIS)
Time frame: Postoperative days 1, 2, and at hospital discharge (day 3-5)
AIS is an 8-item self-report scale. A total score ≥6 indicates clinically significant insomnia/sleep disturbance. Higher scores indicate worse sleep quality.
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 23 Jun 2026.
- 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?
A study testing Percutaneous Acupoint Acupuncture in people with Postoperative Sleep Disturbances and Chronic Post-surgical Pain, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 6 inclusion and 12 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 23 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Sleep Disturbance as Assessed by the Athens Insomnia Scale (AIS) (time frame: Postoperative days 1, 2, and at hospital discharge (day 3-5)). 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 23 Jun 2026.