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

NCT ID: NCT04872712

Last Updated: 2022-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-04

Study Completion Date

2021-10-31

Brief Summary

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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

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Press needles

Intervention Type PROCEDURE

Manual acupuncture using press 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.

Group Type ACTIVE_COMPARATOR

Filiform Needles

Intervention Type PROCEDURE

Manual acupuncture using filiform needles

Interventions

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Press needles

Manual acupuncture using press needles

Intervention Type PROCEDURE

Filiform Needles

Manual acupuncture using filiform needles

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Irma Nareswari, B.MedSc, Sp.Ak

Head of Medical Acupuncture Study Programme University of Indonesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irma Nareswari, dr. Sp.Ak

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

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Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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21-02-0142

Identifier Type: -

Identifier Source: org_study_id

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