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Trial details
Effects of a mindfulness program on the welfare of university students
Current status:
Approved
|
Date registered:
19/09/2023
Trial version(s)
Current: 21/06/2023
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2023065390
Protocol number
FM446
MOH registration number
-
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
21/06/2023
Primary sponsor
Saint Joseph University of Beirut
Primary sponsor: Country of origin
Lebanon
Public title
Effects of a mindfulness program on the welfare of university students
Acronym
-
Scientific title
The effects of a mindfulness program on the reduction of symptoms of anxiety and depression and on the perception of pain and stress in university students
Acronym
-
Brief summary of the study: English
The study aims to evaluate the effects of mindfulness through mindfulness sessions administered by a professional to university students in the health field. Thus, it is a question of following the evolution of the symptoms of anxiety and depression of a group adhering to the training of mindfulness compared to a control group, by means of specific questionnaires. The impact of the mindfulness trait on different students will also be studied. In addition, the influence of this training on the perception of pain will be the subject of a test subjecting the various participants to a painful stimulus and recording their responses in two stages, before and after the mindfulness intervention. Finally, the study aims to compare the reaction of students to acute stress before and after the intervention, by inflicting an uncomfortable nerve stimulation in response to arithmetic mental tasks. Some physiological parameters of stress (heart rate, body temperature, skin conductance and salivary cortisol) will be assessed.
Brief summary of the study: Arabic
تهدف الدراسة إلى تقييم تأثيرات اليقظة الذهنية من خلال جلسات اليقظة التي يديرها متخصص لطلاب في المجال الصحي. وبالتالي ، فإن الأمر يتعلق بمتابعة تطور أعراض القلق والاكتئاب لدى مجموعة ملتزمة بتدريب اليقظة مقارنة بمجموعة، عن طريق استبيانات محددة. سيتم أيضًا دراسة تأثير سمة اليقظة على الطلاب المختلفين. بالإضافة إلى ذلك ، سيكون تأثير هذا التدريب على إدراك الألم موضوع اختبار يُخضع مختلف المشاركين لمحفز مؤلم ويسجل ردودهم على مرحلتين ، قبل وبعد تدخل اليقظة. أخيرًا ، تهدف الدراسة إلى مقارنة تفاعل الطلاب مع ا القلق الحاد قبل التدخل وبعده ، من خلال إحداث تحفيز عصبي غير مريح استجابةً للمهام الذهنية الحسابية. سيتم تسجيل بعض العوامل الفسيولوجية للقلق (معدل ضربات القلب ودرجة حرارة الجسم وموصلية الجلد والكورتيزول اللعابي).
Health conditions/problem studied: Specify
This study is conducted with healthy young adult volunteers and could reduce their symptoms of anxiety, depression and stress. Moreover, mindfulness can have a positive impact on the perception of stress and pain. Therefore, it could be beneficial to students in the health field.
Interventions: Specify
5-7 mindfulness sessions administered by a professional Intervention 2: stress test using TENS (transcutaneous electrical nerve stimulation) Intervention 3: pain induction test using CPT (cold pressor test)
Key inclusion and exclusion criteria: Inclusion criteria
Healthy university students in the health field (aged between 18 and 30 y.o.)
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
30
Key inclusion and exclusion criteria: Exclusion criteria
Has already followed a mindfulness program - Suffers from active chronic pain - Suffers from acute pain at the present moment (wounds, sores, etc.) - Suffers from uncorrected visual disturbance - Suffers from psychiatric disorders - Suffers from a neurological disorder (or other disorder that may alter the perception of pain) - Substance abuse - Taking psychiatric drugs or painkillers - Previous trauma (sexual harassment, explosion, etc.)
Type of Study
Type
Interventional
Type of intervention
Lifestyle changes
Trial scope
Other
Trial scope: Specify scope
Awareness technique - better lifestyle
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
N/A
Study design: Purpose
Other
Study design: Specify purpose
Improving welfare and quality of life
Study design: Assignment
Parallel
Pharmaceutical class
N/A
Therapeutic indication
stress
Therapeutic benefit
stress, anxiety and pain management
Biospecimen retention
Samples without DNA
Biospecimen description
saliva
Target sample size
55
Actual enrollment target size
36
Date of first enrollment: Type
Actual
Date of first enrollment: Date
03/07/2023
Date of study closure: Type
Actual
Date of study closure: Date
21/09/2023
Recruitment status
Recruiting
Date of completion
01/12/2023
IPD sharing statement plan
Yes
IPD sharing statement description
.Individual participant data will be available. 2.Individual participant data that underlie the results reported in the article, will be shared after deidentification. 3.Study protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code will be available. 4.The above data will be shared with researchers who provide a methodologically sound proposal. 5.Sharing data could be done for any purpose of analyses. 6.Proposals should be directed to sandra.kobaitermaarrawi@usj.edu.lb. To gain access, data requestors will need to sign a data access agreement. Proposals may be submitted up to 36 months following article publication. After that time, data will be available in our university Lab database.
Additional data URL
-
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Saint Joseph University of Beirut
FM446
Sources of Monetary or Material Support
Name
Name - Saint Joseph University of Beirut - Faculty of Medicine and Research Council
Secondary Sponsors
Name
-
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Sandra
Kobaiter Maarrawi
USJ
Lebanon
01 421 677
sandra.kobaitermaarrawi@usj.edu.lb
USJ-FM
Scientific
Elsa
Rhayem
USJ
Lebanon
76 536 226
elsa.rhayem@net.usj.edu.lb
USJ-FM
Scientific
Antoun
Yammine
USJ
Lebanon
71 957 527
antoun.yammine@net.usj.edu.lb
USJ-FM
Scientific
Nay
El Hajj
USJ
Lebanon
71 706 646
nay.hajj@net.usj.edu.lb
USJ
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Saint Joseph University of Beirut – Faculty of Medicine – Laboratory of Research in Neuroscience
Sandra Kobaiter Maarrawi
Neuroscience
Approved
Saint Joseph University of Beirut – Faculty of Medicine – Laboratory of Research in Neuroscience
Joseph Maarrawi
Neurosurgery
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
13/12/2022
Pr Michel Scheuer
michel.scheuer@usj.edu.lb
00961 1 421 000 ext 2228
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
stress
2-Propanol (T51.2)
stress
anxiety and depression
2-Propanol (T51.2)
anxiety
Interventions
Intervention
Description
Keyword
Mindfulness
focused awareness and non-judgmental acceptance of the present moment
Mindfulness
Primary Outcomes
Name
Time points
Measure
stress
pre and post intervention
STAI score
pain tolerance
pre and post intervention
cold pressor test – withdrawal duration and pain score
Key Secondary Outcomes
Name
Time points
Measure
Mindfulness traite
pre and post intervention
FFMQ score
Salivary cortisol
pre and post intervention
ELISA concentration
stress
during tests, pre and post intervention
body temperature
stress
during tests, pre and post intervention
skin conductance
stress
during tests, pre and post intervention
heart rate
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial