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The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness

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ClinicalTrials.gov Identifier: NCT04800939
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Tugba CAM YANIK, Mersin University

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.

Condition or disease Intervention/treatment Phase
Sleep Other: Acupressure Other: Plasebo acupressure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, parallel, two-arm, randomized controlled clinical trial
Masking: Single (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.
Primary Purpose: Other
Official Title: The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness of Surgical Nurses During the COVID-19 Pandemic Process
Estimated Study Start Date : April 5, 2021
Estimated Primary Completion Date : June 22, 2021
Estimated Study Completion Date : July 22, 2022

Arm Intervention/treatment
Experimental: Acupressure Group
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
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.
Other Name: Acupress

Placebo Acupressure Group
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
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.
Other Name: Acupress




Primary Outcome Measures :
  1. Sleep quality evaluated using the Pittsburgh Quality Sleep Index [ Time Frame: Change from before implementation and 4th week of practice. ]
    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 :
  1. Daytime sleepiness evaluated using the Epworth Sleepiness Scale [ Time Frame: Change from before implementation and 4th week of practice ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800939


Contacts
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Contact: Tugba CAM YANIK, Master +90 324 361 00 01 ext 4224 tugbacam@mersin.edu.tr

Locations
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Turkey
Mersin University Recruiting
Mersin, Yenişehir, Turkey, 33343
Contact: Mersin Uni         
Sponsors and Collaborators
Mersin University
Investigators
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Study Director: Gulay Altun Ugras, Doctorate Mersin University
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Responsible Party: Tugba CAM YANIK, Research Assistant, Mersin University
ClinicalTrials.gov Identifier: NCT04800939    
Other Study ID Numbers: Mersin Uni
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tugba CAM YANIK, Mersin University:
Acupressure
placebo acupressure
nurses
sleep quality
daytime sleepiness
Additional relevant MeSH terms:
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Sleepiness