Circadian Rhythm Disruption, Sleep Disturbance, Sleep Quality, Social Jet Lag
Conditions
Keywords
Self-acupressure, Social jet lag, Sleep quality, Sleep patterns, Circadian rhythm, University students, Sham-controlled trial
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.
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.
Interventions
OTHERSelf-Acupressure Intervention
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.
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.
Sponsors
Nigde Omer Halisdemir University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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).
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Jet Lag (ΔSJL) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant blinding assessment (treatment guess) | 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. |
| Change in Pittsburgh Sleep Quality Index (PSQI) total score | 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). |
| Change in Epworth Sleepiness Scale (ESS) score | 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). |
Countries
Turkey (Türkiye)
Contacts
CONTACTPınar Erdoğan, Assoc. Prof.
Outcome results
None listed