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Completed

NCT Number: NCT04872712

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Press needles

Procedure

Manual acupuncture using press needles

Filiform Needles

Procedure

Manual acupuncture using filiform needles

Primary outcomes

  1. Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire Score

    Time frame: 6 weeks (4 times measurement : Before the treatment and every 2 weeks until week 6)

    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.

  2. Change in Melatonin Level via Blood Test

    Time frame: 2 weeks ( 2 times measurement : Before the treatment and after the treatment is completed (treatment duration: 2 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2021
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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