Acupressure and Sleep Quality in Elderly Care (ASEQ)

December 13, 2025 updated by: ozlemakkas, Duzce University

The Effect of Acupressure on Sleep Quality Among Elderly People in Institutional Care

This study was carried out in a prospective randomized controlled experimental design in order to evaluate the effect of acupressure on sleep quality and day sleepiness in individuals living in an elderly care center. The study sample consisted of 75 elderly individuals, 38 in experimental and 37 in control groups, who met the inclusion criteria, living in three different care institutions in Düzce. The data were collected using the Elderly Information Form, the Pittsburgh Sleep Quality Index (PSQI), and the Epworth Sleepiness Scale (ESS). Twelve sessions of acupressure were applied to the individuals in the experimental group every other day three times a week for four weeks. Acupressure was applied to Shenmen (HT7), Neiguan (P6), and Sanyinjiao (SP6) acupressure points. The PSQI and ESS were applied on the elderly in the experimental group before and after the application, and on the elderly in the control group before the application and at the end of the 12-session acupressure application in the experimental group. The PSQI and ESS were applied in both groups again one month after the last application. It was found that subjective sleep quality and sleep duration increased, sleep latency decreased, habitual sleep efficiency was regulated, and sleep disorders and daytime dysfunction declined through the application of acupressure in the elderly receiving institutional care. It was determined that the total PSQI score decreased and the quality of sleep increased in the experimental group following the application. Moreover, the ESS score and day sleepiness decreased in the experimental group following the application. Consequently, it was concluded that acupressure could be a supplementary and supportive method to be used for sleep disorders in the elderly.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • stanbul University-Cerrahpaşa ,Graduate School of Health Sciences ,Department of Internal Medicine Nursing
      • Istanbul, Turkey (Türkiye)
        • stanbul University-Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 65 years and older
  • Able to provide informed consent
  • Living in the nursing home during the study period
  • Willing to participate in acupressure sessions and assessments
  • Adequate cognitive ability to complete questionnaires (PSQI, ESS)

Exclusion Criteria:

  • Severe cognitive impairment or dementia preventing questionnaire completion
  • Presence of acute psychiatric disorder or severe communication difficulties
  • Current use of sedative/hypnotic medications affecting sleep quality
  • Severe medical conditions (e.g., terminal illness, unstable cardiovascular disease) that contraindicate participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Participants in the intervention group received acupressure therapy. Acupressure was applied to Shenmen (HT7), Neiguan (P6), and Sanyinjiao (SP6) points. Sessions were conducted three times per week, every other day, for four weeks (12 sessions in total).
Behavioral: Acupressure Therapy
The intervention consisted of acupressure therapy applied to Shenmen (HT7), Neiguan (P6), and Sanyinjiao (SP6) points. Sessions were administered three times per week, every other day, for four consecutive weeks, totaling 12 sessions. Each session lasted approximately 20 minutes and was performed by a trained researcher. Participants were assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS) before and after the intervention
Other Names:
  • Manual Acupressure Therapy
  • Acupressure at HT7, P6, SP6 Points
No Intervention: Control Group
Participants in the control group did not receive any intervention during the study period. They were assessed at the same time points as the intervention group using the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure
Time Frame: Baseline (pre-intervention) and 4 weeks after intervention
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) was developed in 1989 by Buysse and colleagues to assess sleep quality. The scale provides a quantitative measure that allows the identification of "good sleep" and "poor sleep." It evaluates sleep quality, sleep quantity, the presence of sleep disturbances, and their severity over the past month. The scale consists of 24 questions, 19 of which are self-report items. The remaining 5 items are answered by a bed partner or roommate, used solely for clinical information, and are not included in the scoring. The PSQI includes seven components evaluating different aspects of sleep: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, A PSQI score of 5 or higher reflects clinically significant impairment in sleep quality. Based on these thresholds, sleep quality is categorized as good (0-4 points) or poor (5-21 points).
Baseline (pre-intervention) and 4 weeks after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Outcome Measure
Time Frame: Baseline (pre-intervention) and 4 weeks after intervention
Change in daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS). Epworth Sleepiness Scale (ESS) The Epworth Sleepiness Scale (ESS) was developed by Johns in 1991 to assess general daytime sleepiness in adults. The scale consists of 8 self-report items. The Cronbach's alpha reliability coefficient of the ESS was reported as 0.88 in individuals with sleep disorders (Johns, 1991). The ESS evaluates an individual's general level of daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in 8 different everyday situations, asking participants to rate their likelihood of falling asleep on a typical day when they are not excessively tired. Each item is scored between 0 and 3, and the total score ranges from 0 to 24. A total score between 2 and 10 indicates normal daytime sleepiness, whereas a score of 11 or higher suggests increased daytime sleepiness.
Baseline (pre-intervention) and 4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duzce University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Zeliha Tülek, Professor Doctor, Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan Description: De-identified participant-level data will be shared, including:

Pittsburgh Sleep Quality Index (PSQI) scores at baseline and 4 weeks post-intervention

Epworth Sleepiness Scale (ESS) scores at baseline and 4 weeks post-intervention

Demographic variables (age, sex) relevant to analysis

IPD Sharing Time Frame

De-identified individual participant data (IPD) from the published thesis are already available. Specifically, data include Pittsburgh Sleep Quality Index (PSQI) scores, Epworth Sleepiness Scale (ESS) scores, and demographic variables (age, sex). Since the thesis has been published, these datasets are accessible upon request.

IPD Sharing Access Criteria

De-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, informed consent form) will be available to qualified researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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