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

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Procedure: Press needles; Procedure: Filiform Needles

• Registration Number: NCT04872712
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-02
• Study Start: 2021-05-04
• Study First Posted: 2021-05-04
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Press Needles	Press needles	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.
Filiform Needles	Filiform Needles	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.

Primary Outcome Measures

Name	Time	Method
Change in Melatonin Level via Blood Test	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.
Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire Score	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.

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia