NCT04923061

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

June 5, 2021

Last Update Submit

April 4, 2022

Conditions

Keywords

AcupressureSham acupressureNurseSleep qualityFatigue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Fatigue evaluated using the Fatigue Severity Scale

    Change from before implementation and 4th week of practice

Study Arms (2)

Acupressure group

EXPERIMENTAL

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

Other: Acupressure

Sham acupressure group

SHAM COMPARATOR

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

Other: Sham acupressure group

Interventions

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.

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.

Sham acupressure group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, Yenişehir, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FatigueSleep Initiation and Maintenance Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Meral Gun, Doctorate

    Mersin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, parallel, two-arm, randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 5, 2021

First Posted

June 11, 2021

Study Start

April 6, 2021

Primary Completion

June 30, 2021

Study Completion

July 1, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations