The Effects of Qigong Exercises on Acute Anxiety, Mood, and Reaction Time Among Occupational Therapy Students: A Double-Blind, Crossover-Controlled Intervention Study
Phase: NA
Conditions: University Students
Sponsor: Medipol University

Study Protocol and Statistical Analysis Plan 
Official Title: Acute Effects of a Single 60-Minute Baduanjin Qigong Session on Anxiety, 
Mood, and Reaction Time in Undergraduate Students: A Randomized, Double-Blind, 
Crossover Trial 
NCT Number: [to be assigned by ClinicalTrials.gov] 
Date: [25.08.2025] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1. Background and Rationale 
Baduanjin Qigong, a traditional mind-body exercise combining breathing awareness, slow 
rhythmic movements, and mental focus, has been shown to reduce anxiety, stress, and 
depressive symptoms while improving cognitive and physiological outcomes. However, there 
is limited evidence regarding its acute psychological and cognitive effects in healthy young 
adults. 
This randomized, double-blind, crossover trial will examine the short-term effects of a single 
60-minute Baduanjin Qigong session compared with passive rest in undergraduate students. 
 
2. Study Objectives 
Primary Objective: 
To evaluate the acute effect of Baduanjin Qigong on state anxiety (STAI-Y1) immediately 
before and after the intervention. 
Secondary Objectives: 
To assess the effects on mood profile (POMS). 
To evaluate changes in reaction time measured by a computerized visual stimulus test. 
 
3. Study Design 
Design: Randomized, double-blind, crossover trial 
Arms: 
Arm 1 – Baduanjin Qigong: Standardized 60-minute protocol (15 minutes breathing-focused 
warm-up, eight movements of 5 minutes each, 10 minutes breathing-focused closing) led by 
experienced occupational therapists. 
Arm 2 – Passive Rest Control: 60 minutes of seated rest in a quiet room without access to 
electronic devices or distracting materials. 
Crossover: All participants will complete both arms in a randomized sequence with a 1-day 
wash-out period between conditions. 
 
4. Participants 
Population: Undergraduate occupational therapy students (18–25 years) at Medipol 
University. 
Sample Size: Power analysis (G*Power 3.1.9.4) indicated a minimum of 70 participants 
(95% power, 5% significance level). 
Inclusion Criteria: 

Age 18–25 years 
No chronic illness, psychiatric diagnosis, or contraindication for physical exercise 
No prior regular practice of Qigong, yoga, or similar mind-body exercises 
Voluntary participation with informed consent 
Exclusion Criteria: 
Use of antidepressants or psychotropic medication 
Acute pain, infection, or chronic cardiorespiratory disease 
Inability to complete computerized reaction time testing 
 
5. Blinding 
Participants: Unaware of which condition is considered the active intervention 
Outcome Assessors: Independent evaluators blinded to group allocation 
Double-Blind Integrity: Randomization and session scheduling managed by separate 
researchers not involved in data collection 
 
6. Outcome Measures 
Primary Outcome: 
State Anxiety (STAI-Y1) – assessed immediately before and after each intervention session. 
Secondary Outcomes: 
Mood Profile (POMS) – assessed immediately before and after each session. 
Reaction Time – measured using a computerized visual stimulus response test before and 
after each session. 
 
7. Statistical Analysis Plan (SAP) 
Software: SPSS v26.0 
Data Screening: Normality checked using Shapiro–Wilk test; homogeneity of variance 
assessed. 
Primary Analysis: 
Paired t-tests (or Wilcoxon signed-rank test if non-parametric) for within-condition pre/post 
changes. 
Repeated measures ANOVA for condition × time effects in crossover design. 
Secondary Analysis: 

Correlation analyses (Pearson/Spearman) between anxiety, mood, and reaction time changes. 
Effect Size: Cohen’s d or partial eta squared reported. 
Significance Level: α = 0.05 (two-tailed). 
Missing Data: Intention-to-treat (ITT) principle; last observation carried forward for missing 
post-test values. 
 
8. Ethical Considerations 
Approved by the [Insert University Name] Ethics Committee. 
All participants will provide informed consent prior to study entry. 
Confidentiality of participant data will be maintained; data will be stored in encrypted format. 
 
9. Dissemination Plan 
Results will be published in peer-reviewed journals and presented at scientific conferences. 
De-identified data may be shared upon reasonable request.