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Sleep DisordersASEQNCT07277725

Acupressure and Sleep Quality in Elderly Care

A study testing Acupressure Therapy in people with Sleep Disorders, run by Duzce University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Sleep Disorders
What is being tested?
Acupressure Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Apr 2018to 30 Jun 2018
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • stanbul University-Cerrahpaşa ,Graduate School of Health Sciences ,Department of Internal Medicine Nursing

    Istanbul

  • stanbul University-Cerrahpaşa

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Conditions
Sleep Disorders
Being tested
Acupressure Therapy
Keywords
Acupressure, Geriatric, Nursing, Aged care services, Quality of sleep, Sleep Disorder
Medical subject headings
Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupressure TherapyBehavioural

    Also called Manual Acupressure Therapy, Acupressure at HT7, P6, SP6 Points

    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

Study groups in NCT07277725
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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).
Receives: Behavioral: Acupressure Therapy
Control GroupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Outcome Measure

    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).

    Measured: Baseline (pre-intervention) and 4 weeks after intervention

Secondary outcomes (1)

  1. Secondary Outcome Measure

    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.

    Measured: Baseline (pre-intervention) and 4 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start1 Apr 2018
  3. Primary completion30 Jun 2018
  4. Study completion30 Jun 2018

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned to either the intervention group (receiving acupressure) or the control group (no intervention). Randomization was performed using a computer-assisted method to ensure balanced allocation between groups. Both groups were followed concurrently in a parallel design, with assessments conducted at the same time points.
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07277725
Sponsor's protocol ID
2018/25
Acronym
ASEQ
Status last verified
Dec 2025
First submitted
29 Nov 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 29628954

  • 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.

    PubMed 25988270

  • 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.

    PubMed 28884877

Questions about this trial

What is this clinical trial studying?

A study testing Acupressure Therapy in people with Sleep Disorders, run by Duzce University at 2 sites 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 5 inclusion and 4 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Primary Outcome Measure (time frame: Baseline (pre-intervention) and 4 weeks after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07277725, which also lists 3 linked publications.

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 19 Dec 2025.

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