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The Effect of Acupressure on the Sleep Quality and Fatigue

Primary Purpose

Sleep, Fatigue

Status

Active

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Acupressure

Sham acupressure group

About this trial

This is an interventional other trial for Sleep focused on measuring Acupressure, Sham acupressure, Nurse, Sleep quality, Fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mersin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupressure group

Sham acupressure group

Arm Description

The experimental group will apply acupressure to themselves three times a week for a total of 12 sessions for four weeks.

The sham group will apply acupressure to themselves three times a week for a total of 12 sessions for four weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04923061

First Posted

June 5, 2021

Last Updated

April 4, 2022

Sponsor

Mersin University

1. Study Identification

Unique Protocol Identification Number

NCT04923061

Brief Title

The Effect of Acupressure on the Sleep Quality and Fatigue

Official Title

The Effect of Acupressure on Sleep Quality and Fatigue in Nurses Working in Internal Clinics During the COVID-19 Pandemic Process: A Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 6, 2021 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep, Fatigue

Keywords

Acupressure, Sham acupressure, Nurse, Sleep quality, Fatigue

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective, parallel, two-arm, randomized controlled clinical trial

Masking

Participant

Masking Description

As a result of the draw, group A was determined as acupressure and group B as sham acupressure group. Information showing that the nurses included in the research sample were assigned to groups A and B according to the randomization table will be placed in an opaque envelope. This envelope will be kept by the coordinator researcher (MG) and when the researcher with acupressure practice certificate (EC) goes to the nurse for the application, fills out the "Informed Consent Form" and opens the envelope to find out which group the nurse is in. Since all nurses included in the study will be taught to apply pressure to the pressure point, the participants will be blinded as the nurses do not know whether acupressure or sham acupressure is applied. The researcher (EC) cannot be blinded due to the nature of the research.

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupressure group

Arm Type

Experimental

Arm Description

The experimental group will apply acupressure to themselves three times a week for a total of 12 sessions for four weeks.

Arm Title

Sham acupressure group

Arm Type

Sham Comparator

Arm Description

The sham group will apply acupressure to themselves three times a week for a total of 12 sessions for four weeks.

Intervention Type

Other

Intervention Name(s)

Acupressure

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sham acupressure group

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sleep quality evaluated using the Pittsburgh Quality Sleep Index

Description

Time Frame

Change from before implementation and 4th week of practice.

Secondary Outcome Measure Information:

Title

Fatigue evaluated using the Fatigue Severity Scale

Description

Time Frame

Change from before implementation and 4th week of practice

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Meral Gun, Doctorate

Organizational Affiliation

Mersin University

Official's Role

Study Director

Facility Information:

Facility Name

Mersin University

City

Mersin

State/Province

Yenişehir

ZIP/Postal Code

33343

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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The Effect of Acupressure on the Sleep Quality and Fatigue

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