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CompletedNCT04800939Updated Nov 8, 2022

The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness

An interventional study of Acupressure and Plasebo acupressure in Sleep, sponsored by Mersin University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Mersin University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sleep

Keywords

  • Acupressure
  • placebo acupressure
  • nurses
  • sleep quality
  • daytime sleepiness
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • 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

  • Other
    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

Interventions

  • OtherAcupressure

    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

  • OtherPlasebo 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.

    Also known as: Acupress

05

What researchers measure

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.

    Time frame: Change from before implementation and 4th week of practice.

Secondary outcomes

  1. 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.

    Time frame: Change from before implementation and 4th week of practice

06

Study locations

1 site
  • Mersin University
    Mersin, Yenişehir 33343, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04800939
Lead sponsor
Mersin University
Responsible party
Tugba CAM YANIK (Research Assistant, Mersin University) — Principal investigator
First posted
Mar 16, 2021
Start date
Mar 28, 2021
Primary completion
Apr 15, 2021
Completion
May 15, 2021
Last update
Nov 8, 2022

Study contacts

Gulay Altun Ugras, Doctorate
study director · Mersin University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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