NCT07277725

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 29, 2025

Last Update Submit

December 13, 2025

Conditions

Keywords

AcupressureGeriatricNursingAged care servicesQuality of sleepSleep Disorder

Outcome Measures

Primary Outcomes (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).

    Baseline (pre-intervention) and 4 weeks after intervention

Secondary Outcomes (1)

  • Secondary Outcome Measure

    Baseline (pre-intervention) and 4 weeks after intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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).

Interventions

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

Also known as: Manual Acupressure Therapy, Acupressure at HT7, P6, SP6 Points
Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Istanbul, Turkey (Türkiye)

Location

stanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 29628954BACKGROUND
  • 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.

    PMID: 25988270BACKGROUND
  • 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.

    PMID: 28884877BACKGROUND

MeSH Terms

Conditions

Sleep Wake DisordersSleep Initiation and Maintenance Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomnias

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Zeliha Tülek, Professor Doctor

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 11, 2025

Study Start

April 1, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
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.
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.
More information

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