Effects of Self-Acupressure on Social Jet Lag, Sleep Patterns, and Sleep Quality in Female Health Sciences Students: A Sham-Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Social Jet Lag (ΔSJL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Self-Acupressure Intervention (Other)
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.
干预措施: Sham Self-Acupressure (Other)
结局指标
主要结局
Change in Social Jet Lag (ΔSJL)
时间窗: 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).
次要结局
- 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))
研究者
Pınar Erdoğan
Assoc. Prof.
Nigde Omer Halisdemir University