Clinical trial NCT04872712: Comparing Press and Filiform Needle Acupuncture Effectiveness for Improving Insomnia in COVID-19 Healthcare Workers
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Acupuncture
Press Needle
Insomnia
Healthcare worker
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire Score
timeFrame: 6 weeks (4 times measurement : Before the treatment and every 2 weeks until week 6)
measure: Change in Melatonin Level via Blood Test
timeFrame: 2 weeks ( 2 times measurement : Before the treatment and after the treatment is completed (treatment duration: 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Irma Nareswari, dr. Sp.Ak
role: PRINCIPAL_INVESTIGATOR
References: