- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410936
Self-Acupressure and Social Jet Lag in Female Health Sciences Students
Effects of Self-Acupressure on Social Jet Lag, Sleep Patterns, and Sleep Quality in Female Health Sciences Students: A Sham-Controlled Randomized Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Social jet lag, defined as the misalignment between biological circadian rhythms and socially imposed schedules, is highly prevalent among university students and is associated with impaired sleep quality, daytime sleepiness, and adverse health outcomes. Female students in health sciences programs may be particularly vulnerable due to academic workload and irregular schedules. Non-pharmacological, self-administered interventions that can be easily integrated into daily routines may offer a practical approach to improving sleep-related outcomes in this population.
This study is a randomized, parallel-group, sham-controlled trial designed to investigate the effects of a 12-week self-acupressure intervention on social jet lag and sleep-related outcomes. Eligible participants are female health sciences students who will be randomized in a 1:1 ratio to either a self-acupressure intervention group or a sham self-acupressure control group. Both groups receive standardized training and apply their respective protocols daily for the same duration and frequency.
The experimental intervention consists of self-administered acupressure applied to predefined acupoints (HT7, SP6, and Yintang) using moderate, comfortable, non-painful pressure. The sham intervention is matched in duration, frequency, and pressure but is applied to non-acupoint locations not recognized as therapeutic acupressure points. This design aims to control for nonspecific effects such as attention, expectation, and tactile stimulation.
Outcomes are assessed at baseline and at the end of the 12-week intervention period. The primary outcome is the change in social jet lag. Secondary outcomes include changes in sleep quality, daytime sleepiness, sleep pattern parameters, and assessment of participant blinding success. Blinding effectiveness is evaluated by asking participants to guess their group assignment at follow-up.
The study is conducted under minimal risk conditions, and all participants provide written informed consent prior to enrollment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pınar Erdoğan, Assoc. Prof.
- Phone Number: +905233646954
- Email: drpinarerdogan@gmail.com
Study Locations
-
-
Merkez
-
Niğde, Merkez, Turkey (Türkiye), 51240
- Recruiting
- Niğde Ömer Halisdemir University Hospital
-
Contact:
- Pınar Erdoğan, Assoc. Prof.
- Phone Number: 05233646954
- Email: drpinarerdogan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Acupressure Intervention (HT7, SP6, Yintang)
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.
|
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.
|
|
Sham Comparator: Sham Self-Acupressure
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Social Jet Lag (ΔSJL)
Time Frame: Baseline (T0) and Week 12 (end of 3-month follow-up); primary analysis uses change from baseline to Week 12 (T12 - T0)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant blinding assessment (treatment guess)
Time Frame: At 1 month and 3 months after baseline
|
Participant-reported guess of group assignment, assessed using a single-item categorical question with three response options: "active self-acupressure," "sham self-acupressure," or "unsure."
The proportion of correct guesses will be used to evaluate the success of blinding.
Blinding will be considered successful if the proportion of correct guesses does not significantly exceed chance level.
|
At 1 month and 3 months after baseline
|
|
Change in Pittsburgh Sleep Quality Index (PSQI) total score
Time Frame: Baseline (T0) and Week 12; change from baseline to Week 12 (T12 - T0)
|
Change in Pittsburgh Sleep Quality Index (PSQI) total score.
The PSQI total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
The outcome is defined as the change in total score from baseline to Week 12 (Week 12 - baseline).
|
Baseline (T0) and Week 12; change from baseline to Week 12 (T12 - T0)
|
|
Change in Epworth Sleepiness Scale (ESS) score
Time Frame: Baseline (T0) and Week 12; change from baseline to Week 12 (T12 - T0)
|
Change in Epworth Sleepiness Scale (ESS) score.
The ESS total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
The outcome is defined as the change in total score from baseline to Week 12 (Week 12 - baseline).
|
Baseline (T0) and Week 12; change from baseline to Week 12 (T12 - T0)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average nightly sleep duration (work/school days vs free days)
Time Frame: Mean nightly sleep duration calculated over the 14 days immediately preceding baseline and over the 14 days immediately preceding Week 12.
|
Average nightly sleep duration (hours), calculated separately for work/school days and free days using a 14-day sleep diary.
|
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
Time Frame: Mean sleep onset latency calculated over the 14 days immediately preceding baseline and over the 14 days immediately preceding Week 12.
|
Self-reported time to fall asleep (minutes) recorded in the 14-day sleep diary.
|
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)
Time Frame: Week 12
|
Participant-reported satisfaction with the intervention assessed using a single-item numeric rating scale ranging from 0 to 10, where 0 indicates no satisfaction and 10 indicates maximum satisfaction.
Higher scores indicate greater satisfaction.
|
Week 12
|
|
Intervention adherence (% of sessions)
Time Frame: Week 12 (calculated over the 12-week intervention period).
|
Adherence calculated as the percentage of completed sessions out of the total prescribed sessions during the 12-week intervention period, based on participant logs.
|
Week 12 (calculated over the 12-week intervention period).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22504254-050.04/18-60
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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