- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04800939
The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness
November 7, 2022 updated by: Tugba CAM YANIK, Mersin University
The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness of Surgical Nurses During the COVID-19 Pandemic Process
This randomized controlled trial evaluates the effect of acupressure application on nurses' sleep quality and daytime sleepiness providing care in surgical clinics.
This study hypothesizes that acupressure improves sleep quality and reduces daytime sleepiness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Methods: In the study, 60 nurses were randomly assigned to acupressure and placebo acupressure groups.
To the acupressure group (n = 30), an average of 10 minutes will be applied to the Shen Men, the 7th acupoint (HT7) of the heart meridian located between the ulna and pisiform bones, on the radial side of the flexor carpi ulnaris tendon, and the Sanyinjia points on the splenic meridian (SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the tibia.
In the placebo acupressure group (n = 30), the points 1.5 cm away from the HT7 and SP6 points (four points in total) will be applied for an average of 10 minutes.
The primary outcome of the research is the effect of acupressure on the sleep quality of nurses.
The secondary outcome of the study is to determine the effect of acupressure on daytime sleepiness.
The outcomes will be collected before and four weeks after the acupressure and placebo acupressure administration.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yenişehir
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Mersin, Yenişehir, Turkey, 33343
- Mersin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
The experimental group criteria to be included in the study;
- Caring for COVID-19 patients during the research,
- Working in surgery services before the pandemic,
- Agree to participate in the survey (those who signed the Informed Consent Form),
- Do not have physical problems that prevent acupressure application to HT7 (wrist) and SP6 (over four fingers of the ankle) points,
- No experience of acupressure,
- Not diagnosed with sleep disorder and not receiving medical treatment,
- No coffee, cigarette, and alcohol addiction,
- No mental illness,
- Working in the night shift,
- Don't work more than three-night shifts a week.
The control group criteria to be included in the study;
- Caring for COVID-19 patients during the research,
- Working in surgery services before the pandemic,
- Agree to participate in the survey (those who signed the Informed Consent Form),
- Do not have physical problems that prevent acupressure application to points 1.5 cm away from HT7 (wrist) and SP6 (4 fingers above the ankle) points,
- No experience of acupressure,
- Not diagnosed with sleep disorder and not receiving medical treatment,
- No coffee, cigarette, and alcohol addiction,
- No mental illness,
- Working in the night shift,
- Do not work more than three-night shifts a week.
Exclusion Criteria:
The experimental group criteria not to be included in the study;
- Do not care for COVID-19 patients during the research,
- Do not work in surgery services before the pandemic,
- Do not agree to participate in the study,
- Having physical problems that prevent acupressure application to HT7 (wrist) and SP6 (over four fingers of the ankle) points,
- Diagnosed with sleep disorder and receiving medical treatment,
- Using drugs that cause sleep problems (antidepressants, analgesics, beta-adrenoreceptor antagonists, dopamine agonists, etc.),
- Addicted to coffee, cigarette, and alcohol,
- With mental illness,
- Working more than three-night shifts a week,
- Working on a fixed day shift.
The control group criteria not to be included in the study;
- Do not care for COVID-19 patients during the research,
- Do not work in surgery services before the pandemic,
- Do not agree to participate in the study,
- Having physical problems that prevent acupressure application to points 1.5 cm away from HT7 (wrist) and SP6 (4 fingers above the ankle) points,
- Diagnosed with sleep disorder and receiving medical treatment,
- Using drugs that cause sleep problems (antidepressants, analgesics, beta adrenoreceptor antagonists, dopamine agonists, etc.),
- Addicted to coffee, cigarette, and alcohol,
- With mental illness,
- Working more than three-night shifts a week,
- Working on a fixed day shift.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupressure Group
The experimental group will be given acupressure on their own, three times a week for four weeks, one hour before going to bed at night.
|
The experimental group will start with HT7 points and continue with SP6 points.
The application will be carried out by determining the priority order of the points with the draw.
Attention will be paid to the intensity and duration of the pressure deemed appropriate.
Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage.
Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm.
With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved.
After, the point determined will be pressed manually for 2 minutes.
Other Names:
|
|
Other: Placebo Acupressure Group
The control group will be given plasebo acupressure on their own, three times a week for four weeks, one hour before going to bed at night.
|
In the control group, the application will start with the points 1.5 cm around the HT7 and SP6 points.
The application process will continue in the same way with acupressure group and the pressure intensity will be less.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality evaluated using the Pittsburgh Quality Sleep Index
Time Frame: Change from before implementation and 4th week of practice.
|
The total scale score is in the range of 0 (minimum) -21 (maximum), and the high total Pittsburgh Quality Sleep Index (PSQI) score indicates that sleep quality is low.
A total PSQI score between 0-4 indicates good sleep quality, while between 5-21 shows that sleep quality is low.
|
Change from before implementation and 4th week of practice.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daytime sleepiness evaluated using the Epworth Sleepiness Scale
Time Frame: Change from before implementation and 4th week of practice
|
This scale, which is a four-point Likert type, aims to evaluate the probability of sleepiness during the individual's daily life between 0-3 points.
The scale score is in the range of 0 (minimum) -24 (maximum), and a total Epworth Sleepiness Scale score of 11 or above indicates excessive daytime sleepiness.
|
Change from before implementation and 4th week of practice
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gülay Altun Uğraş, doctorate, Mersin University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2021
Primary Completion (Actual)
April 15, 2021
Study Completion (Actual)
May 15, 2021
Study Registration Dates
First Submitted
March 11, 2021
First Submitted That Met QC Criteria
March 14, 2021
First Posted (Actual)
March 16, 2021
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 7, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mersin Uni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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