- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07816419
Yogic Eye Exercises for Computer Vision Syndrome in Female Design Students
Effect of a Four-Week Yogic Eye Exercise Program on Computer Vision Syndrome Symptoms in Female University Students: A Single-Arm Pre-Post Study
Computer vision syndrome (CVS) is a cluster of eye and musculoskeletal complaints - dryness, redness, blurred vision, foreign body sensation, excessive tearing, and neck, shoulder or back pain - that arises from prolonged work at a digital display. It is common among university students, and optical, pharmacological and nutritional treatments have given inconsistent results. Yoga-based eye exercises have been proposed as a brief, inexpensive alternative that requires no equipment.
This study tested whether a short, structured programme of yogic eye exercises reduces self-reported CVS symptoms in female undergraduates in a graphic design and digital media programme, a group whose coursework demands sustained, colour-critical near work at a screen.
All 36 female students enrolled in the programme took part. Each attended one supervised training session and then performed a 13-minute sequence of relaxation exercises (slow blinking, gazing at a distant target, acupressure around the eyes) and strengthening exercises (eye rolling, nose-tip gazing) three days a week for four weeks, a total of 12 sessions, reporting completion of each session on the same day.
Nine symptoms - five ocular and four musculoskeletal - were rated on a four-point scale (never, rarely, sometimes, always) at the start and again at the end of week 4. The main question was whether the average of all nine ratings fell over the four weeks. Every participant served as her own comparison; there was no control group and no masking.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Design. Single-arm, pre-post interventional study in which each participant served as her own control, conducted in the Graphic Design and Digital Media programme of Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia. No control group was recruited and no masking was applied.
Participants. All 36 female students enrolled in the programme were invited and all agreed, so the convenience sample was a complete enumeration of the eligible cohort. The programme admits female students only. All participants were in the 18-22 year age band.
Intervention. Participants were trained in a single supervised group session before baseline and given written and illustrated instructions. Each session comprised relaxation exercises (slow blinking; gazing at a fine detail of a distant target; acupressure massage of periocular points) followed by strengthening exercises (eye-rolling movements; nose-tip gazing, in which the participant focuses on the extended thumb, moves it slowly toward the nose tip, holds for five seconds and moves it away). The combined sequence took approximately 13 minutes and was performed three days per week for four consecutive weeks, giving 12 sessions in total. After the training session participants practised independently and reported completion of each session the same day in a monitored group thread, so adherence was verified session by session rather than recalled at the end.
Assessment. Symptoms were assessed with an adapted electronic questionnaire administered at baseline and at the end of week 4. The instrument was developed by reviewing validated instruments in the literature, refining items with subject-matter experts and pilot testing in six female students. It recorded demographic details, medical history relevant to ocular surface dryness, habitual computer use, and nine symptom items each rated on a 4-point Likert scale (1 = never, 2 = rarely, 3 = sometimes, 4 = always). The identical instrument and platform were used at both time points.
Analysis. The primary outcome, the total symptom score, and the two domain scores were compared with the paired-samples t-test, with the Wilcoxon signed-rank test reported alongside where normality was not supported; item-level differences were tested with the Wilcoxon signed-rank test. Because nine item-level comparisons were made, p-values were adjusted by the Holm-Bonferroni procedure. No data were imputed and no subgroup or interaction analyses were performed. No formal a priori sample size calculation was performed; the study enrolled the entire eligible cohort.
Registration. This record was created retrospectively. The study was investigator-initiated and approved by the Princess Nourah bint Abdulrahman University Institutional Review Board on 20 December 2020, before the first participant was enrolled on 15 March 2021. The design, intervention and outcome measures recorded here are those specified in the approved protocol and are unchanged.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Riyadh, Arabia Saudyjska, 11671
- : Princess Nourah bint Abdulrahman University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Female undergraduate enrolled in the Graphic Design and Digital Media programme at Princess Nourah bint Abdulrahman University
- Use of a computer for at least one month before the study
- Able to read and understand English
- Provided written informed consent
Exclusion Criteria:
- Diagnosis of Sjögren syndrome
- Diagnosis of keratoconjunctivitis sicca
- Use of medications known to reduce tear production, for example antihistamines
- Use of isotretinoin
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Yogic eye exercise programme
All participants received the same intervention: a 13-minute session of yogic relaxation and strengthening eye exercises, performed three days per week for four consecutive weeks (12 sessions).
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A 13-minute sequence performed three days per week for four consecutive weeks (12 sessions in total). Relaxation component: slow blinking; gazing at a fine detail of a distant target; acupressure massage of periocular points. Strengthening component: eye-rolling movements; nose-tip gazing (focus on the extended thumb, move it slowly toward the nose tip, hold five seconds, move away; repeat twice, approximately 25 seconds per cycle). Delivery: one supervised group training session before baseline, written and illustrated instructions, then independent home practice with same-day reporting of each completed session in a monitored group thread. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline in total symptom score at week 4
Ramy czasowe: Baseline and week 4
|
Arithmetic mean of all nine self-reported symptom items - five ocular (eye dryness, red eye, foreign body sensation, blurred vision, excessive tearing) and four musculoskeletal (shoulder pain, back pain, loss of sensation in the fingers, loss of sensation in the hands) - each rated on a 4-point Likert scale (1 = never, 2 = rarely, 3 = sometimes, 4 = always).
The total score ranges from 1 to 4; lower scores indicate fewer symptoms.
Collected by self-completed electronic questionnaire.
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Baseline and week 4
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline in ocular symptom domain score at week 4
Ramy czasowe: Baseline and week 4
|
Mean of five self-reported ocular symptom items - eye dryness, red eye, foreign body sensation, blurred vision and excessive tearing - each rated on a 4-point Likert scale (1 = never to 4 = always).
The domain score ranges from 1 to 4; lower scores indicate fewer symptoms.
|
Baseline and week 4
|
|
Change from baseline in muscular symptom domain score at week 4
Ramy czasowe: Baseline and week 4
|
Mean of four self-reported musculoskeletal symptom items - shoulder pain, back pain, loss of sensation in the fingers and loss of sensation in the hands - each rated on a 4-point Likert scale (1 = never to 4 = always).
The domain score ranges from 1 to 4; lower scores indicate fewer symptoms.
|
Baseline and week 4
|
|
Change from baseline in each individual symptom item at week 4
Ramy czasowe: Baseline and week 4
|
Each of the nine symptom items analysed separately: eye dryness, red eye, foreign body sensation, blurred vision, excessive tearing, shoulder pain, back pain, loss of sensation in the fingers, loss of sensation in the hands.
Each is rated on a 4-point Likert scale (1 = never to 4 = always); lower scores indicate fewer symptoms.
|
Baseline and week 4
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Baseline screen-use behaviour
Ramy czasowe: Baseline
|
Descriptive characterisation of daily computer use (<2, 2-4, 4-6, >6 hours), daily screen viewing in darkness (same bands), and whether computer use was continuous or interrupted by breaks.
|
Baseline
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- KingSaudU_20-0528E
- 20-0528E (Inny identyfikator: Princess Nourah bint Abdulrahman University Institutional Review Board (IRB registration with KACST: H-01-R-059))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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