Yoga for Physical and Mental Health

Stress Clinical Trial

Official title:

Physical and Mental Health. Effects of Yoga as a Therapeutic Tool.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06304662
• Other study ID #: *University of Jaén
• Status: Completed
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: February 19, 2024

Study information

• Verified date: March 2024
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 19, 2024
• Est. primary completion date: February 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• University students who do not participate in any physical exercise program
• Sufficient physical autonomy to participate in the physical activities required by the study
• That they are able to understand the instructions, programs and protocols of this project. Exclusion Criteria:- University students who have serious physical or mental conditions
• Lack of commitment to regular attendance
• Extensive previous experience in yoga

Related Conditions & MeSH terms

• Stress

Intervention

Other:
• Yoga intervention
Over 12 weeks, students will attend 50-minute yoga sessions twice a week. Sessions start with 10 minutes of mindful breathing and gentle warm-up movements, followed by 30 minutes of tailored yoga postures for relaxation and stretching. Students progress from basic to advanced postures, with adaptations for individual needs. Each session ends with a guided meditation for inner calm. A 10-minute cool-down encourages deep relaxation. Emphasis is on stress reduction, flexibility, and mindfulness, tailored to university life challenges. Continuous assessment ensures sessions meet students' evolving needs and optimize yoga's benefits in the university setting.

Locations

Country	Name	City	State
Spain	Agustín Aibar Almazán	Jaén

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	D2 test	Evaluates selective attention and concentration in the school context. The participant's task is to check carefully, starting from left to right, what is written on each line and must mark all the letters that have two small lines (two below, two above or one below and one above) with a "d". ". These elements are considered relevant. The other combinations (the "d" and the "p", with and without dashes) are considered irrelevant and should not be marked. The participant has 20 s for each line. This test has shown excellent reliability, with ranges between 0.90 and 0.97 for both Cronbach's a and the test-retest, and has also shown convergent and divergent validity.	Up to twelve weeks
Primary	Mindful Attention Awareness Scale (MAAS)	It evaluates, in a global way, the dispositional capacity of an individual to be attentive and aware of the experience of the present moment in everyday life. The scale is a 15-item univariate self-report with a view of the mindfulness construct centered on the attention / consciousness variable.	Up to twelve weeks
Primary	Handgrip Strength	Dynamometer will be employed to assess hand grip strength.	Up to twelve weeks
Primary	Anxiety and Depression	Hospital Anxiety and Depression Scale (HADS). This scale consists of 14 items with 4 response alternatives ranging from 0 to 3 for a total of 0 to 21 points. It has 2 subscales and the score is obtained by adding the scores of each item that make it up, the interpretation criteria being the following: Range of normality (0-7), Possible case of anxiety or depression (8-10) and Case of anxiety or depression (11-21).	Up to twelve weeks
Primary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-assessment questions or items and 5 more to be completed by the person with whom the participant shares a bed or room (although the latter is only used to provide clinical information). These items generate a total score and 7 components or domains: sleep quality; sleep latency; sleep duration; sleep efficiency; sleep disorders; use of sleeping medications; daytime dysfunction. The PSQI total score ranges from 0 to 21, with a higher score indicating poorer sleep quality.	Up to twelve weeks
Primary	Stress level	Perceived Stress Scale (PSS). This scale is a self-report instrument that evaluates the level of perceived stress during the last month, it consists of 14 items with a response format of a five-point scale (0 = never, 1 = almost never, 2 = occasionally when, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10 and 13 (in the following sense: 0=4, 1=3, 2=2, 3=1 and 4 =0) and then adding the 14 items. The direct score obtained indicates that a higher score corresponds to a higher level of perceived stress.	Up to twelve weeks
Primary	The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)	is a 14-items questionnaire of mental well-being including subjective well-being and psychological functioning. All items in a 5-point Likert scale are worded positively and addressed aspects of positive mental health and measure the frequency of the subject's attitudes from "never" to "always". Higher scores indicate mental well-being. The Italian version of the WEMWB proved to be a reliable instrument, as indicated by a Cronbach's alpha that ranged from 0.83 to 0.864. The authors of the Italian WEMWBS reported for the students a mean score of 41.45 ± 6.66.	Up to twelve weeks
Primary	State Anxiety Inventory (STAI)	This version includes 40 items (i.e. 20 for each subscale). In the Spanish adaptation, the response scale ranges from 0 to 3 points, by contrast with the original STAI, in which it ranges from 1 to 4 points (Spielberger et al., 1970). In the state anxiety subscale, item scores range between 0 = nada [not at all], 1 = algo [somewhat], 2 = bastante [moderately] and 3 = mucho [very much]. In the trait anxiety subscale, response options range between 0 = casi nunca [almost never], 1 = a veces [sometimes], 2 = a menudo [often] and 3 = casi siempre [almost always]. Although each subscale has a theoretical range from 20 to 80, the scores can be compared to those of the original scale by adding 20 to the scores obtained.	Up to twelve weeks
Primary	Attentional Control: Shifting and Distraction (AC-S and AC-D)	are two questionnaires derived from the Attentional Control Scale developed by Derryberry and Reed16. Attentional distraction and Attentional Shifting differences are 2 different factors which Attentional Control Scale have. For the study ACS is separated into 2 different scales (AC-D and AC-S) each having 4 different statements which were rescored to provide consistency. All items on both questionnaires are graded on a 5-point Likert scale, with 1 being almost never and 5 being always. Higher score for both questionnaires indicates higher attentional distraction and difficulties in attentional shifting. The psychometric properties of this questionnaire have been tested also in its Italian version, indicating a Cronbach's alfa of 0.83 for AC-S and 0.75 for AC-D9. The authors of the original version of AC-S and AC-D reported over a population of Canadian students a mean score of 2.76±0.65 for the AC-S scale 3.30±0.79 for the AC-D scale	Up to twelve weeks
Primary	Positive and Negative Affect Schedule	measures two general dimensions: i) Positive affect (PA) refers to how energetic, enthusiastic, and alert a person feels. The participant has to express how much he/she experience generally each affect in a 5-point-scale from "not at all" to "very much". Low PA is associated with melancholy and lethargy, whereas high PA is associated with great energy, focus, and enjoyment. ii) Negative affect (NA) is a condition of overall distress and unpleasant engagement, with a low NA indicating peace and serenity. The Italian version of the PANAS proved to be a reliable instrument, as indicated by a Cronbach's alpha that ranged from 0.83 to 0.8711. The authors of the Italian version of PANAS reported a mean score of 27±7 in the PA subscale while a mean score of 16±6.2 in the NA subscale in a sample of N=600 participants, with a mean age of 27.9±9.78.	Up to twelve weeks
Primary	Difficulties in Emotion Regulation Scale (DERS)	Es una de las pruebas más utilizadas para evaluar los problemas de control emocional en adultos. La escala de autoinforme de 36 ítems se utiliza para generar puntuaciones en las siguientes seis subescalas preguntando a los encuestados cómo se conectan con sus emociones: a) no aceptación de las respuestas emocionales; b) dificultad para participar en un comportamiento dirigido a objetivos; c) dificultades en el control de los impulsos; d) falta de conciencia emocional; e) Acceso limitado a estrategias de regulación de las emociones; yf) falta de claridad emocional. Para calificar cada ítem se utiliza una escala Likert de 5 puntos, desde 1 que es "casi nunca" hasta 5 que es "casi siempre". Una puntuación más alta indica mayores dificultades en la regulación de las emociones, en otras palabras, una mayor desregulación emocional.	Up to twelve weeks