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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04872712
Enrollment
34
Registered
2021-05-04
Start date
2021-05-04
Completion date
2021-10-31
Last updated
2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Acupuncture, Press Needle, Insomnia, Healthcare worker

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.

Interventions

PROCEDUREPress needles

Manual acupuncture using press needles

PROCEDUREFiliform Needles

Manual acupuncture using filiform needles

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator do not know the respondents. There will be 3 Outcomes Assessors who will randomly assess the respondents. The laboratory assistant will not be informed of the treatments provided to the respondents.

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire Score6 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.
Change in Melatonin Level via Blood Test2 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.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026