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

Insomnia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872712
• Other study ID #: 21-02-0142
• Status: Completed
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Procedure:
• Press needles
Manual acupuncture using press needles
• Filiform Needles
Manual acupuncture using filiform needles

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)