THE ROLE OF MANUAL ACUPUNCTURE USING PRESS NEEDLES COMPARED WITH FILIFORM NEEDLES IN IMPROVING SYMPTOMS OF INSOMNIA AND MELATONIN HORMONE FOR HEALTHCARE WORKERS TREATING COVID-19 PATIENTS.

Overview

The purpose of this study is to compare the effectiveness of manual acupuncture between 2 types of needles in subsiding insomnia symptoms of healthcare workers who were responsible for treating COVID-19 Patients in Cipto Mangunkusumo hospital.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 7, 2022

Detailed Description

The purpose of this study is to compare the effectiveness of manual acupuncture between press needles and filiform needles for subsiding insomnia symptoms based on changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire score and examination of Melatonin in blood. If the press needles proven to be superior, this method would also be more beneficial during this pandemic as this can shorten the time and/or frequency of the therapy sessions, hence reducing interaction and risk of COVID-19 transmission.

Interventions

  • Procedure: Press needles
    • Manual acupuncture using press needles
  • Procedure: Filiform Needles
    • Manual acupuncture using filiform needles

Arms, Groups and Cohorts

  • Active Comparator: Press Needles
    • The subjects/population of this study is Health Workers with insomnia symptoms who work at at Cipto Mangunkusumo Hospital treating COVID-19 patients. Subjects group with Press Needles treatment will be treated with 2-week needle retention, 20-second pressing 3 times a day and needle replacement performed every 5 days. The needles are inserted 0.9 mm deep at the acupuncture points HT7 Shenmen, PC6 Neiguan, ST36 Zusanli and SP6 Sanyinjiao.
  • Active Comparator: Filiform Needles
    • The subjects/population of this study is Health Workers with insomnia symptoms who work at at Cipto Mangunkusumo Hospital treating COVID-19 patients. Subjects group with filiform needles treatment will be treated with 20-minute needle retention, 3 times a week for 2 weeks (total of 6 therapy sessions). The needles are inserted approximately 12 mm deep at the acupuncture points HT7 Shenmen and PC6 Neiguan and 25 mm deep at the ST36 Zusanli and SP6 Sanyinjiao.

Clinical Trial Outcome Measures

Primary Measures

  • Pittsburgh Sleep Quality Index questionnaire
    • Time Frame: 6 weeks (4 times measurement : Before the treatment and every 2 weeks until week 6)
    • questionnaire for Insomnia
  • Hormone Melatonin
    • Time Frame: 2 weeks ( 2 times measurement : Before the treatment and after the treatment is completed (treatment duration: 2 weeks)
    • Hormone marker for sleep

Participating in This Clinical Trial

Inclusion Criteria

  • Health care workers treating COVID-19 patients in Cipto Mangunkusumo Hospital. – Has Symptoms of insomnia for at least 2 weeks (as reflected by the score of at least 1 for the question 3a in the modified PHQ-9 questionnaire). – Age 20 – 50 years. – Has negative COVID-19 rapid test or PCR swab result in the 7 days prior to the study. – Willing to participate in research by signing an informed consent. – Willing to follow the research process to completion. Exclusion Criteria:

  • If you answered Yes to PHQ-9 number 3a never or 3b with a yes – Insomnia is caused by moderate pain (with Numeric Rating Scale > 4) – Insomnia patients with medical therapy such as benzodiazepines, non-benzodiazepines, melatonin drugs and antidepressants – Has severe social and occupational dysfunction (with Global Assesment of Functioning < 50). – Has a history of contraindications to acupuncture such as medical emergencies, pregnancy, thrombocytopenia with a platelet count below 50,000 per microliter of blood, history of blood clotting disorders / taking blood thinners, puncturing over malignant tumors, or infection or scarring in the acupuncture area. – The patient is febrile with a temperature more than 38 Celsius – Have had acupuncture in the last 7 days prior to study. – No limbs – Cognitive impairments or impaired consciousness

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Irma Nareswari, B.MedSc, Sp.Ak, Head of Medical Acupuncture Study Programme University of Indonesia – Indonesia University
  • Overall Official(s)
    • Irma Nareswari, dr. Sp.Ak, Principal Investigator, Fakultas Kedokteran Universitas Indonesia
  • Overall Contact(s)
    • Irma Nareswari, dr. Sp.Ak, 6281385657878, i.nareswarifkuirscm@yahoo.com

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