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
机构:[1]Department of Gynecology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China大德路总院妇科大德路总院妇科广东省中医院[2]Nursing Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China大德路总院珠海院区护理部护理部护理部广东省中医院[3]Department of Psychological Sleep, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China广东省中医院
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. Trial registration: Chinese Clinical Trial Registry (identifier: ChiCTR2200056890).
第一作者机构:[1]Department of Gynecology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China
通讯作者:
通讯机构:[1]Department of Gynecology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China[*1]Deputy Chief of Nursing, 261 Datong Road, Yuexiu District, Guangzhou 510105, China.
推荐引用方式(GB/T 7714):
He Guang-Lian,Gong Xiao-Zhen,He Jing-Ling,et al.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[J].ANNALS OF TRANSLATIONAL MEDICINE.2022,10(14):doi:10.21037/atm-22-2980.
APA:
He, Guang-Lian,Gong, Xiao-Zhen,He, Jing-Ling,Yang, Qing,Mai, Jia-Yong...&Guo, Qing-Hua.(2022).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.ANNALS OF TRANSLATIONAL MEDICINE,10,(14)
MLA:
He, Guang-Lian,et al."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".ANNALS OF TRANSLATIONAL MEDICINE 10..14(2022)