Back to resultsComparing Press and Filiform Needle Acupuncture Effectiveness for Improving Insomnia in COVID-19 Healthcare Workers
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Press needles
Filiform Needles
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Acupuncture, Press Needle, Insomnia, Healthcare worker
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
Sites / Locations
- Cipto Mangunkusumo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Press Needles
Filiform Needles
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04872712
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Acupuncture, Press Needle, Insomnia, Healthcare worker
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Press Needles
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Filiform Needles
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Press needles
Intervention Description
Manual acupuncture using press needles
Intervention Type
Procedure
Intervention Name(s)
Filiform Needles
Intervention Description
Manual acupuncture using filiform needles
Primary Outcome Measure Information:
Title
Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire Score
Description
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.
Time Frame
6 weeks (4 times measurement : Before the treatment and every 2 weeks until week 6)
Title
Change in Melatonin Level via Blood Test
Description
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.
Time Frame
2 weeks ( 2 times measurement : Before the treatment and after the treatment is completed (treatment duration: 2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irma Nareswari, dr. Sp.Ak
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Press and Filiform Needle Acupuncture Effectiveness for Improving Insomnia in COVID-19 Healthcare Workers
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