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Evaluation of the effects of intradermal needle therapy on sleep quality in patients following laparoscopic hysterectomy

Evaluation of the effects of intradermal needle therapy on sleep quality in patients following laparoscopic hysterectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005653
Enrollment
Unknown
Registered
2022-02-22
Start date
2022-02-22
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

perioperative disease

Interventions

Experimental group:basic postoperative care and undergo authentic intradermal needle therapy
Control group:basic postoperative care and sham intradermal needle therapy will be performed

Sponsors

Guangdong Hospital of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index Scale (PSQI);

Secondary

MeasureTime frame
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);

Countries

China

Contacts

Public ContactGuanglian He
15920107152@163.com15920107152

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026