Evaluation of the effects of intradermal needle therapy on sleep quality in patients following laparoscopic hysterectomy
- Conditions
- perioperative disease
- Registration Number
- ITMCTR2200005653
- Lead Sponsor
- Guangdong Hospital of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
Patients eligible for inclusion will be selected with reference to the Total Hysterectomy: Surgical Method for Benign Disease edited by Waters et al. (Beijing People's Military Medical Publishing House, 2012). Briefly, study inclusion criteria will be as follows: (1) women diagnosed with non-malignant uterine tumors or adnexal masses, or with early-stage tumors (including stage IA1 tumors and carcinoma in situ) that meet the surgical indications for laparoscopic total hysterectomy; (2) individuals 18-65 years of age; (3) American society of anesthesiologists (ASA) grade I-II patients, with anesthesia being achieved via tracheal intubation, an operative duration < 4 h, and < 300 mL of intraoperative blood loss; (4) individuals without any history of short-term or chronic insomnia; (5) patients without reported preoperative mental health disorders, illnesses, or a history of substance abuse or sedative drug abuse; and (6) patients that agree to participate in the study and provide written informed consent
Patients will be excluded from participation in the present study if they meet any of the following criteria: (1) patients with a history of sleep disorders, mental health disorders, or sedative drug abuse; (2) patients with severe primary or secondary diseases affecting major organs including the brain, kidney, liver, or heart; (3) patients with local skin wounds, infections, or tape allergies at the target acupoints; (4) patients that have participated in other clinical trials within the past year; and (5)patients diagnosed with diabetes.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index Scale (PSQI);
- Secondary Outcome Measures
Name Time Method Postoperative pain, as measured using a visual analog scale (VAS);The 10-item identity-consequence fatigue scale short form (ICFS-10);The time to first postoperative anal exhaust and defecation;The total duration of postoperative hospitalization.;The Hospital Anxiety and Depression Scale-Anxiety (HADS-A);