NCT07410936

Brief Summary

This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on social jet lag, sleep patterns, and sleep quality in female health sciences students. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be performed daily for 12 weeks. Outcomes will be assessed at baseline and at the end of the intervention period, with the primary outcome being the change in social jet lag. Secondary outcomes include changes in sleep quality, daytime sleepiness, and participant blinding assessment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 7, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

Self-acupressureSocial jet lagSleep qualitySleep patternsCircadian rhythmUniversity studentsSham-controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change in Social Jet Lag (ΔSJL)

    Change in social jet lag (hours), calculated as the absolute difference between mid-sleep time on free days (MSF) and mid-sleep time on work/school days (MSW), derived from a Munich Chronotype Questionnaire (MCTQ)-based assessment and a 14-day sleep diary. Social jet lag values range from 0 hours upward, with higher values indicating greater circadian misalignment. The primary outcome is defined as the change in social jet lag from baseline to Week 12 (Week 12 - baseline).

    Baseline (T0) and Week 12 (end of 3-month follow-up); primary analysis uses change from baseline to Week 12 (T12 - T0)

Secondary Outcomes (3)

  • Participant blinding assessment (treatment guess)

    At 1 month and 3 months after baseline

  • Change in Pittsburgh Sleep Quality Index (PSQI) total score

    Baseline (T0) and Week 12; change from baseline to Week 12 (T12 - T0)

  • Change in Epworth Sleepiness Scale (ESS) score

    Baseline (T0) and Week 12; change from baseline to Week 12 (T12 - T0)

Other Outcomes (4)

  • Average nightly sleep duration (work/school days vs free days)

    Mean nightly sleep duration calculated over the 14 days immediately preceding baseline and over the 14 days immediately preceding Week 12.

  • Subjective sleep onset latency

    Mean sleep onset latency calculated over the 14 days immediately preceding baseline and over the 14 days immediately preceding Week 12.

  • Participant satisfaction (0-10)

    Week 12

  • +1 more other outcomes

Study Arms (2)

Self-Acupressure Intervention (HT7, SP6, Yintang)

EXPERIMENTAL

Participants receive structured training in self-administered acupressure at predefined acupoints (HT7, SP6, and Yintang) and are instructed to apply the protocol at home with the same frequency and session duration throughout the study period, using moderate, comfortable, non-painful pressure.

Other: Self-Acupressure Intervention

Sham Self-Acupressure

SHAM COMPARATOR

Participants receive training in sham self-acupressure matched to the experimental intervention in session duration and frequency. Sham acupressure is applied using the same instruction format and time schedule as the experimental arm, but at non-acupoint locations that are not recognized as therapeutic acupressure points. Participants are instructed to apply moderate, comfortable pressure (non-painful), consistent with the experimental arm.

Other: Sham Self-Acupressure

Interventions

Participants receive structured training in self-administered acupressure at predefined acupoints (HT7, SP6, and Yintang). Training is provided face-to-face at baseline. Participants are instructed to apply acupressure daily at home using moderate, comfortable, non-painful pressure. Each session is performed according to the study protocol for a total duration of 12 weeks.

Self-Acupressure Intervention (HT7, SP6, Yintang)

Participants receive structured training in sham self-acupressure matched to the experimental intervention in frequency, session duration, and pressure. Sham acupressure is applied daily at non-acupoint locations that are not recognized as therapeutic acupressure points, using moderate, comfortable, non-painful pressure, for a total duration of 12 weeks.

Sham Self-Acupressure

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female undergraduate students enrolled in midwifery or medical programs
  • Age 18 to 25 years
  • Regular academic schedule (work/school days and free days identifiable)
  • Willingness to participate and provide written informed consent
  • Ability to comply with daily self-acupressure practice for 12 weeks
  • Ability to complete sleep questionnaires and sleep diary

You may not qualify if:

  • Current diagnosis of a sleep disorder requiring medical treatment (e.g., obstructive sleep apnea, narcolepsy)
  • Use of medications known to significantly affect sleep or circadian rhythms (e.g., hypnotics, stimulants)
  • Shift work or night work during the study period
  • Transmeridian travel (≥2 time zones) within the past 4 weeks or planned during the study period
  • Chronic medical or psychiatric condition that may significantly affect sleep
  • Current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University Hospital

Niğde, Merkez, 51240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ParasomniasSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomnias

Central Study Contacts

Pınar Erdoğan, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors are blinded to group allocation. Blinding success will be assessed by asking participants at follow-up to guess their group assignment (active vs sham vs unsure).
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a two-arm, parallel-group, randomized, sham-controlled trial. Participants are individually randomized in a 1:1 ratio to either a self-acupressure intervention or a sham self-acupressure control. There is no crossover between study arms, and all participants are followed for 12 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

February 15, 2026

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly. De-identified data will be stored securely and used only for the purposes of this study and related publications, in accordance with institutional ethics approval.

Locations