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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04800939
Other study ID # Mersin Uni
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 28, 2021
Est. completion date May 15, 2021

Study information

Verified date November 2022
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 15, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Acupressure
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.
Plasebo acupressure
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.

Locations

Country Name City State
Turkey Mersin University Mersin Yenisehir

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep quality evaluated using the Pittsburgh Quality Sleep Index 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.
Secondary Daytime sleepiness evaluated using the Epworth Sleepiness Scale 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
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