Evaluation of the efficacy and safety of intradermal needle therapy on the sleep quality of patients following laparoscopic hysterectomy: study protocol for a randomized controlled trial

Abstract

Background: Sleep disorder is a commonly reported complication in patients who have undergone a hysterectomy, which increases perioperative complications and delays patient recovery. Several pharmacological and non-pharmacological approaches have been employed to improve the quality of sleep of patients during the postoperative period, but these strategies have certain limitations. Intradermal needle therapy is now among the most common treatments for insomnia in traditional Chinese medicine (TCM).The present study was developed to explore the effects of intradermal needle therapy (as an adjunct to physiotherapy-based treatments for postoperative sleep impairment) on the postoperative sleep quality of patients who have undergone a laparoscopic hysterectomy.Methods: This is a prospective, single-center, single-blind, randomized controlled trial. In total, 80 eligible patients will be randomly allocated to the control and experimental groups at a 1:1 ratio. Random numbers and grouping schemes will be generated using the SPSS 25.0 software package. Following the completion of the laparoscopic hysterectomy procedure, the patients will be returned to the medical ward and undergo authentic or sham intradermal needle therapy as appropriate. For patients in the experimental group, following sterilization, intradermal needles will be inserted into the bilaterally "Shenmen" (HT36) and "Sanyinjiao" (SP6) acupoints; the needles will be replaced after 24 h. False intradermal needles that exhibit similar surface characteristics but lack needles will be employed in the control group. Patients will undergo a single 3-day treatment course. The primary outcome is the Pittsburgh Sleep Quality Index. The secondary outcomes are the 10-Item Short-Form Identity-Consequence Fatigue Scale, the Hospital Anxiety and Depression Scale-Anxiety, and postoperative pain scores, which will be rated using a visual analog scale. Time to postoperative defecation and the duration of hospitalization will also be recorded.Discussion: The present study seeks to examine the efficacy of the intradermal needle as a therapeutic tool for improving the sleep quality of patients after surgery who have undergone a laparoscopic hysterectomy to provide a foundation for future large-scale clinical studies.

Effect of intradermal needle therapy at combined acupoints on patients’ gastrointestinal function following surgery for gastrointestinal tumors

“…Due to its notable therapeutic advantages, INT has recently been applied in the treatment of a range of conditions. A recent protocol developed a randomized controlled trial to examine whether INT at the Shenmen (HT36) and Sanyinjiao (SP6) acupoints would improve postoperative sleep quality in patients undergoing laparoscopic hysterectomy[ 15 ]. One study explored the effects of INT on hemiplegia recovery after stroke[ 16 ], while another study summarized the effectiveness of INT for treating gastric diseases by describing clinical cases[ 17 ].…”