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The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness

Primary Purpose

Sleep

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupressure
Plasebo acupressure
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep focused on measuring Acupressure, placebo acupressure, nurses, sleep quality, daytime sleepiness

Eligibility Criteria

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

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.

Sites / Locations

  • Mersin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Acupressure Group

Placebo Acupressure Group

Arm Description

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.

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.

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

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.

Full Information

First Posted
March 11, 2021
Last Updated
November 7, 2022
Sponsor
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT04800939
Brief Title
The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness
Official Title
The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness of Surgical Nurses During the COVID-19 Pandemic Process
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 28, 2021 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep
Keywords
Acupressure, placebo acupressure, nurses, sleep quality, daytime sleepiness

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
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupressure Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Acupressure Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupressure
Other Intervention Name(s)
Acupress
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Plasebo acupressure
Other Intervention Name(s)
Acupress
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep quality evaluated using the Pittsburgh Quality Sleep Index
Description
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.
Time Frame
Change from before implementation and 4th week of practice.
Secondary Outcome Measure Information:
Title
Daytime sleepiness evaluated using the Epworth Sleepiness Scale
Description
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.
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
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulay Altun Ugras, 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
No

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The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness

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