NCT04800939

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

March 28, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

18 days

First QC Date

March 11, 2021

Last Update Submit

November 7, 2022

Conditions

Keywords

Acupressureplacebo acupressurenursessleep qualitydaytime sleepiness

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)

  • Daytime sleepiness evaluated using the Epworth Sleepiness Scale

    Change from before implementation and 4th week of practice

Study Arms (2)

Acupressure Group

EXPERIMENTAL

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.

Other: Acupressure

Placebo Acupressure Group

OTHER

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.

Other: Plasebo acupressure

Interventions

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.

Also known as: Acupress
Acupressure Group

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.

Also known as: Acupress
Placebo Acupressure Group

Eligibility Criteria

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

You may qualify if:

  • 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),
  • +7 more criteria

You may not qualify if:

  • 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,
  • +7 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

Sleep Initiation and Maintenance DisordersDisorders of Excessive Somnolence

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gulay Altun Ugras, Doctorate

    Mersin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
According to the randomization table, the information showing the nurses included in the research sample is assigned to the A and B groups will be put in an opaque envelope. This envelope will be kept by the coordinator researcher (GAU) when the researcher (TÇY), who has an acupressure application certificate, goes to the nurse's application. After filling out the "Informed Consent Form," he will open the envelope and learn which group the nurse is in. Since all nurses included in the study will be applied to the compression point, the participants will be blinded because they do not know that they are a study or control group. The researcher (TÇY), on the other hand, cannot be blinded due to the nature of the research. A statistician will analyze the data, and the findings will be reported.
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

March 11, 2021

First Posted

March 16, 2021

Study Start

March 28, 2021

Primary Completion

April 15, 2021

Study Completion

May 15, 2021

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations