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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04923061
Other study ID # MersinUniversityNursing
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 6, 2021
Est. completion date July 2022

Study information

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

Clinical Trial Summary

This research aims to determine the effect of acupressure applied to nurses actively working in internal clinics on sleep quality and fatigue during the COVID-19 pandemic process. This research hypothesizes that acupressure improves sleep quality and reduces fatigue.


Description:

In this study, 68 nurses working in internal clinics were randomly assigned to acupressure and placebo (sham) acupressure groups. In the acupressure group (n=34), the heart meridian 7th point (HT7), large intestine meridian 4th point (LI4), stomach meridian 36th point (ST36) and spleen meridian 6th point (SP6) will be applied to a total of four points. Depending on the preparation and compression time on each point, the session duration of each nurse will be 20 minutes on average. In the sham group (n=34), pressure will be made approximately 1-1.5 cm away from the HT7, LI4, ST36, SP6 points. In the Sham group, the acupressure application time will take 20 minutes on average. Reminder text messages (SMS) will be sent before the application on the days when the nurses will practice, so that they continue to do the application regularly. At the end of the application, after the data collection process is completed, the sham group will be taught the correct acupressure points. Nurses will apply acupressure three times a week for a total of 12 sessions for four weeks. 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 fatigue. The outcomes will be collected before and four weeks after the acupressure and sham acupressure administration.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 68
Est. completion date July 2022
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Nurses who care for COVID 19 patients during the pandemic process Nurses working in internal clinics during the data collection process Those who have recovered from COVID 19 Those who agreed to participate in the study No deformity or lesions in the areas where acupressure will be applied No acupressure experience No sleep disorder diagnosis and no medical treatment Not diagnosed with anxiety disorder and not receiving medical treatment Not diagnosed with depression and not receiving medical treatment Coffee, cigarette and alcohol free No mental disorder Night shift workers Those who can understand and speak Turkish Those who signed the Informed Consent Form Exclusion Criteria: Nurses who did not work in internal clinics during the data collection process Nurses who do not care for COVID 19 patients during the pandemic process Those with active COVID 19 Those who do not agree to participate in the study Those who have any deformity or lesion in the areas where acupressure will be applied Experiences of acupressure Heart and kidney failure, severe anemia, immunodeficiency problem Pregnant Diagnosed with sleep disorder and receiving treatment Anxiety disorder and treatment Depression diagnosed and treated Coffee, cigarette and alcohol addiction Having mental illness Fixed day shift workers Those who can not understand and speak Turkish Those who did not sign the Informed Consent Form

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acupressure
In the acupressure group, heart meridian 7th point (HT7), large intestine meridian 4th point, stomach meridian 36th point (ST36) and spleen meridian 6th point (SP6) will be applied. Tissue sensitivity will be reduced by heating and rubbing for about 20 seconds without direct pressure on the acupressure points, and the points will be ready for acupressure application. Subsequently, consecutive (breathing rhythm) compressions will be applied to the acupressure points determined by the researcher, without raising the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief Since the symmetry of the selected four different points will also be applied to the other extremity, a total of 16 minutes of compression will be applied to each point, provided that it is two minutes. Each nurse's session will be approximately 20 minutes, depending on the preparation and compression time on each point.
Sham acupressure group
In the sham group, acupressure will be applied on the bone region where the meridians do not pass, approximately 1-1.5 cm away from the HT7, LI4, ST36, 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 Fatigue evaluated using the Fatigue Severity Scale It is a Likert-type scale consisting of a total of nine items, each item being evaluated between 1 and 7 (1=I totally disagree, 7=I totally agree). The fatigue score is obtained by dividing the total score obtained from the scale by the number of scale items. The score that can be obtained from the scale varies between 9 and 63. A high score indicates an increased level of fatigue. Change from before implementation and 4th week of practice
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