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Efficacy of theta-burst stimulation on postoperative quality of recovery in patients with preoperative anxiety undergoing breast surgery: a prospective, single-center, randomized controlled trial

Efficacy of theta-burst stimulation on postoperative quality of recovery in patients with preoperative anxiety undergoing breast surgery: a prospective, single-center, randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129065
Enrollment
Unknown
Registered
2026-07-30
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign and malignant breast tumours

Interventions

Control group:Receive sham stimulation, with the stimulation process and time schedule being the same as those of the intervention group, but without generating effective magnetic stimulation.
Intervention group:First, perform iTBS stimulation on the left DLPFC. After approximately 20 minutes, conduct another iTBS stimulation, with a total of 2 stimulations.

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18–65 years; 2.ASA classification I–III; 3.Proposed elective breast-conserving surgery for breast cancer or benign lumpectomy of breast; 4.Patients with a score of >=12 on the Amsterdam Preoperative Anxiety and Information Scale (APAIS); 5.Voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Contraindications for rTMS (such as intracranial metal implants, pacemakers, personal or family history of epilepsy); 2.Long-term use of opioids, sedative medications (within three months), or a diagnosis of chronic pain syndrome; 3.Severe mental or cognitive dysfunction that prevents them from communicating or cooperating with the assessment; 4.History of drug or alcohol abuse; 5.Pre-operative pre-existing neurological deficits; 6.Pregnant or breastfeeding women; 7.Any other circumstances that the researcher considers unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Quality of Recovery;

Secondary

MeasureTime frame
Resting and movement pain scores;Record of the use of postoperative analgesic drugs;Adverse events / Serious adverse events;

Countries

China

Contacts

Public ContactHu Xin

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

hx02q89@rjh.com.cn+86 21 64370045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026