SleepNCT04800939
The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness
A study testing Acupressure and Plasebo acupressure in people with Sleep, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Acupressure and Plasebo acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Mar 2021to 15 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness of Surgical Nurses During the COVID-19 Pandemic Process
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.
- Conditions
- Sleep
- Being tested
- Acupressure, Plasebo acupressure
- Keywords
- Acupressure, placebo acupressure, nurses, sleep quality, daytime sleepiness
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Also called Acupress
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.
Plasebo acupressureOther
Also called Acupress
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Plasebo acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from before implementation and 4th week of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start28 Mar 2021
- Primary completion15 Apr 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel, two-arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba CAM YANIK, Mersin University
- Investigators
- Gulay Altun Ugras, Doctorate, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800939
- Sponsor's protocol ID
- Mersin Uni
- Status last verified
- Nov 2022
- First submitted
- 11 Mar 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on the Sleep Quality and Daytime Sleepiness of Surgical Nurses During the COVID-19 Pandemic Process
- ClinicalTrials.gov ID
- NCT04800939
- Acronym / sponsor ID
- Mersin Uni
- Conditions
- Sleep
- Keywords
- Acupressure, placebo acupressure, nurses, sleep quality, daytime sleepiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, parallel, two-arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group | Experimental | Other: AcupressureThe experimental group will be given acupressure on their own, three times a week for four weeks, one hour before going to bed at night. |
| Placebo Acupressure Group | Other | Other: Plasebo acupressureThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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,
Key exclusion criteria (22 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureAlso: AcupressThe 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 | Acupressure Group |
| Plasebo acupressureAlso: AcupressIn 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 | Placebo Acupressure Group |
Primary outcome
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.
1 secondary outcome
Daytime sleepiness evaluated using the Epworth Sleepiness Scale
Time frame: Change from before implementation and 4th week of practice
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulay Altun Ugras, Doctorate study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and Plasebo acupressure in people with Sleep, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality evaluated using the Pittsburgh Quality Sleep Index (time frame: Change from before implementation and 4th week of practice.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.