- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07277725
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- 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
-
-
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Istanbul, Turkey (Türkiye)
- stanbul University-Cerrahpaşa ,Graduate School of Health Sciences ,Department of Internal Medicine Nursing
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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
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 |
Intervention / Treatment |
|---|---|
|
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).
|
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:
|
|
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
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).
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Baseline (pre-intervention) and 4 weeks after intervention
|
Secondary Outcome Measures
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.
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Baseline (pre-intervention) and 4 weeks after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
- Yeung WF, Ho FY, Chung KF, Zhang ZJ, Yu BY, Suen LK, Chan LY, Chen HY, Ho LM, Lao LX. Self-administered acupressure for insomnia disorder: a pilot randomized controlled trial. J Sleep Res. 2018 Apr;27(2):220-231. doi: 10.1111/jsr.12597. Epub 2017 Sep 8.
- Yeh CH, Kwai-Ping Suen L, Chien LC, Margolis L, Liang Z, Glick RM, Morone NE. Day-to-Day Changes of Auricular Point Acupressure to Manage Chronic Low Back Pain: A 29-day Randomized Controlled Study. Pain Med. 2015 Oct;16(10):1857-69. doi: 10.1111/pme.12789. Epub 2015 May 19.
- Samadi P, Alipour Z, Lamyian M. The Effect of Acupressure at Spleen 6 Acupuncture Point on the Anxiety Level and Sedative and Analgesics Consumption of Women during Labor: A Randomized, Single-blind Clinical Trial. Iran J Nurs Midwifery Res. 2018 Mar-Apr;23(2):87-92. doi: 10.4103/ijnmr.IJNMR_199_16.
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)
April 1, 2018
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
November 29, 2025
First Submitted That Met QC Criteria
November 29, 2025
First Posted (Estimated)
December 11, 2025
Study Record Updates
Last Update Posted (Actual)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 13, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Sleep Initiation and Maintenance Disorders
- Sleep Wake Disorders
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Acupressure
Other Study ID 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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