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

U

University of Indonesia (UI)

Status

Completed

Conditions

Insomnia

Treatments

Procedure: Press needles
Procedure: Filiform Needles

Study type

Interventional

Funder types

Other

Identifiers

NCT04872712
21-02-0142

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups

Press Needles
Active Comparator group
Description:
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.
Treatment:
Procedure: Press needles
Filiform Needles
Active Comparator group
Description:
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.
Treatment:
Procedure: Filiform Needles

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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