Comparing Press and Filiform Needle Acupuncture Effectiveness for Improving Insomnia in COVID-19 Healthcare Workers

Comparison of the Effectiveness of Manual Acupuncture Therapy Between Press Needle and Filiform Needle for Symptoms of Insomnia and Melatonin Hormone Serum on COVID-19 Frontline Health Workers at RSCM.

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 Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Procedure: Press needles; Procedure: Filiform Needles

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Health care workers treating COVID-19 patients in Cipto Mangunkusumo Hospital.
• Has Symptoms of insomnia for at least 2 weeks (screened using the PHQ-9 instrument modified to question number 3a with an answer score of at least 1)
• 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 the Global Assessment 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Press needles; Manual acupuncture using press needles
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.	Procedure: Filiform Needles; Manual acupuncture using filiform needles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire Score	Pittsburgh Sleep Quality Index (PSQI) Questionnaire used have 19 questions related to sleep quality and disturbances, grouped into seven-component scores. The seven components of the score were then summed to produce the global PSQI score, which has a range from 0 as minimum and 21 as maximum score. Higher Total PSQI score indicates poorer sleep quality. The PSQI score was measured at 4 time points per subject (Before the treatment and every 2 weeks until week 6) to understand the change and impact before and after the treatment as well as the lasting effect within 4 weeks of treatment was finished.	6 weeks (4 times measurement : Before the treatment and every 2 weeks until week 6)
Change in Melatonin Level via Blood Test	Melatonin Level was measured through blood sampling and test to determine the level of melatonin (in pg/mL) in the human serum. The higher the Melatonin Level indicates better outcome. The Melatonin Level was measured 2 times for all subjects (Before and after the treatment which is in span of 2 weeks) to understand the change and impact before and after the treatment.	2 weeks ( 2 times measurement : Before the treatment and after the treatment is completed (treatment duration: 2 weeks)

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Irma Nareswari, dr. Sp.Ak, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: May 2, 2021
• First Submitted That Met QC Criteria: May 2, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture; Insomnia; Healthcare worker; Press Needle
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 21-02-0142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No